Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-26 @ 7:30 AM
Study NCT ID:
NCT04093492
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbasir@mcw.edu', 'phone': '414-266-6820', 'title': 'Dr. Mir A Basir', 'organization': 'Medical College of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of study participation; total weeks depends on gestational age at enrollment (16 to 21 weeks GA) and gestational age at delivery (i.e., up to 27 weeks).', 'description': 'Adverse events were not assessed for support persons, as we did not have access to their medical records.', 'eventGroups': [{'id': 'EG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. 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These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ACOG Links', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Parent Prematurity Knowledge Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '29.3', 'spread': '7.1', 'groupId': 'OG002'}, {'value': '25.6', 'spread': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 25th week of pregnancy.", 'description': 'Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items. Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Parent Prematurity Knowledge Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '27.9', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '25.7', 'spread': '3.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 30th week of pregnancy.", 'description': 'Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items. Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Parent Prematurity Knowledge Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '24.2', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '20.5', 'spread': '6.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 34th week of pregnancy.", 'description': 'Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. 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These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '29.5', 'groupId': 'OG001'}, {'value': '76.8', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '57.1', 'spread': '31.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 25th week of pregnancy.", 'description': "Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preparation for Decision Making Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '69.2', 'spread': '23.6', 'groupId': 'OG002'}, {'value': '61.1', 'spread': '14.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 30th week of pregnancy.", 'description': "Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). 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These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '54.2', 'spread': '28.5', 'groupId': 'OG001'}, {'value': '69.3', 'spread': '24.0', 'groupId': 'OG002'}, {'value': '63.6', 'spread': '23.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 34th week of pregnancy.", 'description': "Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participant', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '49.9', 'spread': '5.6', 'groupId': 'OG002'}, {'value': '52.3', 'spread': '8.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '53.8', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '49.5', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '52.4', 'spread': '6.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 25th week of pregnancy.", 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '48.5', 'spread': '7.9', 'groupId': 'OG002'}, {'value': '53.0', 'spread': '8.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 30th week of pregnancy.", 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '50.9', 'spread': '9.0', 'groupId': 'OG002'}, {'value': '53.0', 'spread': '7.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': "Assessed at participant's 34th week of pregnancy.", 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decision Self-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '91.6', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '88.3', 'spread': '13.4', 'groupId': 'OG002'}, {'value': '95.0', 'spread': '8.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline', 'description': "Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decision Self-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'OG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'OG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '85.8', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '86.8', 'spread': '12.3', 'groupId': 'OG002'}, {'value': '86.8', 'spread': '15.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 34 weeks of pregnancy', 'description': "Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Patients', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'FG001', 'title': 'American College of Obstetricians and Gynecologists (ACOG) Links - Patients', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'FG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'FG003', 'title': 'American College of Obstetricians and Gynecologists (ACOG) Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}], 'periods': [{'title': '25 Weeks Gestational Age (GA)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Delivered before assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'No response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': '30 Weeks GA', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Unless a participant chose to withdraw, they were considered enrolled and eligible for future assessments (i.e., a participant may have not responded to the 25 week questionnaire but still have been eligible and responded to the 30 week questionnaire). Therefore the number of participants who start a period may not be equal to the number who completed the previous period.', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'Unless a participant chose to withdraw, they were considered enrolled and eligible for future assessments (i.e., a participant may have not responded to the 25 week questionnaire but still have been eligible and responded to the 30 week questionnaire). Therefore the number of participants who start a period may not be equal to the number who completed the previous period.', 'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Delivered before assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'No response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '34 Weeks GA', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Unless a participant chose to withdraw, they were considered enrolled and eligible for future assessments (i.e., a participant may have not responded to the 25 week questionnaire but still have been eligible and responded to the 34 week questionnaire). Therefore the number of participants who start a period may not be equal to the number who completed the previous period.', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'Unless a participant chose to withdraw, they were considered enrolled and eligible for future assessments (i.e., a participant may have not responded to the 25 week questionnaire but still have been eligible and responded to the 34 week questionnaire). Therefore the number of participants who start a period may not be equal to the number who completed the previous period.', 'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Delivered before assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'No response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'BG001', 'title': 'ACOG Links - Pregnant Participants', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'BG002', 'title': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.\n\nPreemie Prep for Parents (P3) Outpatient Mobile Intervention: The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.'}, {'id': 'BG003', 'title': 'ACOG Links - Support Persons', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.\n\nACOG links: Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-24 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': '25-34 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}]}, {'title': '35-46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '158', 'groupId': 'BG004'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}, {'title': 'Black', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'American Indian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'American Indian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Row population is divided by ethnicity (Hispanic/non-Hispanic).'}, {'title': 'Gestational age at enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': '16 weeks GA', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': '17 weeks GA', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': '18 weeks GA', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': '19 weeks GA', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': '20 weeks GA', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': '21 weeks GA', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': '22 weeks GA', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': '9-12th grade, no diploma', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'High school diploma or equivalent', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Some college', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': '2-year degree', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': '4-year degree', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Graduate or professional degree', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-09', 'size': 259642, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-09T14:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2019-09-13', 'resultsFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-06', 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parent Prematurity Knowledge Questionnaire', 'timeFrame': "Assessed at participant's 25th week of pregnancy.", 'description': 'Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items. Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.'}, {'measure': 'Parent Prematurity Knowledge Questionnaire', 'timeFrame': "Assessed at participant's 30th week of pregnancy.", 'description': 'Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items. Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.'}, {'measure': 'Parent Prematurity Knowledge Questionnaire', 'timeFrame': "Assessed at participant's 34th week of pregnancy.", 'description': 'Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.'}, {'measure': 'Preparation for Decision Making Scale', 'timeFrame': "Assessed at participant's 25th week of pregnancy.", 'description': "Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision."}, {'measure': 'Preparation for Decision Making Scale', 'timeFrame': "Assessed at participant's 30th week of pregnancy.", 'description': "Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision."}, {'measure': 'Preparation for Decision Making Scale', 'timeFrame': "Assessed at participant's 34th week of pregnancy.", 'description': "Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision."}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Assessed at baseline', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.'}, {'measure': 'Anxiety', 'timeFrame': "Assessed at participant's 25th week of pregnancy.", 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.'}, {'measure': 'Anxiety', 'timeFrame': "Assessed at participant's 30th week of pregnancy.", 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.'}, {'measure': 'Anxiety', 'timeFrame': "Assessed at participant's 34th week of pregnancy.", 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.'}, {'measure': 'Decision Self-Efficacy', 'timeFrame': 'Assessed at baseline', 'description': "Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy."}, {'measure': 'Decision Self-Efficacy', 'timeFrame': 'Assessed at 34 weeks of pregnancy', 'description': "Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gestational age', 'multi-media', 'mobile application', 'anxiety', 'clinical trial', 'random allocation'], 'conditions': ['Premature Birth', 'Decision Making', 'Prenatal Care', 'Resuscitation', 'Infant, Premature']}, 'referencesModule': {'references': [{'pmid': '39647248', 'type': 'DERIVED', 'citation': "Basir MA, McDonnell SM, Brazauskas R, Kim UO, Ahamed SI, McIntosh JJ, Pizur-Barnekow K, Pitt MB, Kruper A, Leuthner SR, Flynn KE. Effect of fathers in Preemie Prep for Parents (P3) program on couple's preterm birth preparedness. Patient Educ Couns. 2025 Mar;132:108599. doi: 10.1016/j.pec.2024.108599. Epub 2024 Dec 4."}, {'pmid': '38010656', 'type': 'DERIVED', 'citation': 'McDonnell SM, Flynn KE, McIntosh JJ, Brazauskas R, Kim UO, Ahamed SI, Basir MA. Video Education in Early Pregnancy and Parent Knowledge of Neonatal Resuscitation Options: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2344645. doi: 10.1001/jamanetworkopen.2023.44645.'}, {'pmid': '37523163', 'type': 'DERIVED', 'citation': 'Flynn KE, McDonnell SM, Brazauskas R, Ahamed SI, McIntosh JJ, Pitt MB, Pizur-Barnekow K, Kim UO, Kruper A, Leuthner SR, Basir MA. Smartphone-Based Video Antenatal Preterm Birth Education: The Preemie Prep for Parents Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 31;177(9):921-9. doi: 10.1001/jamapediatrics.2023.1586. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.', 'detailedDescription': 'This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making.\n\nParticipants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age.\n\nAt study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Gender is a de facto criteria of inclusion, in that we will first be recruiting pregnant women. However, her partner or support person, should they wish to participate, may be of any gender.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman or her partner\n* At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications.\n* Gestational age of 16-21 weeks at recruitment.\n* Owns a smartphone.\n* Able to speak English\n\nExclusion Criteria:\n\n• Pregnancies with known significant birth defects.'}, 'identificationModule': {'nctId': 'NCT04093492', 'briefTitle': 'Preemie Prep For Parents (P3): Home Antenatal Prematurity Education', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education', 'orgStudyIdInfo': {'id': 'PRO00033902'}, 'secondaryIdInfos': [{'id': 'R21HD092664', 'link': 'https://reporter.nih.gov/quickSearch/R21HD092664', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention', 'description': 'The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.', 'interventionNames': ['Other: Preemie Prep for Parents (P3) Outpatient Mobile Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACOG links', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.', 'interventionNames': ['Other: ACOG links']}], 'interventions': [{'name': 'Preemie Prep for Parents (P3) Outpatient Mobile Intervention', 'type': 'OTHER', 'description': 'The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.', 'armGroupLabels': ['Preemie Prep for Parents (P3) Outpatient Mobile Intervention']}, {'name': 'ACOG links', 'type': 'OTHER', 'description': 'Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.', 'armGroupLabels': ['ACOG links']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mir A Basir', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}