Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05139251
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Women's parenting stress as assessed by the Parental Stress scale (PSS)", 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'PSS is an 18-item questionnaire and the participants rate each item on a scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), a higher score indicating more stress'}, {'measure': 'Change in social support as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v 2.0 Emotional Support', 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'The PROMIS emotional support tool has 16 items and the participants respond each item using a 5-point rating scale from 1(never)-5(always) a higher score indicating more emotional support'}, {'measure': 'Change in social support as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v 2.0 Informational Support', 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'The PROMIS informational support is a 10 items and participants respond each item using a 5-point rating scale (Health Measures) anchored by 1(never)-5(always) with a higher score indicating a better outcome'}, {'measure': "Change in women's empowerment as assessed by the Personal Progress Scale-Revised (PPS-R)", 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'PPS-R is a 28-item self-report measure on which participants rate the extent to which they agreed or disagreed with each item on a 7-point scale.'}, {'measure': 'Change in self efficacy as assessed by the General Self- Efficacy Scale (GSE)', 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'GSE is a 10 item scale. Participants respond to statements such as "I can solve most problems if I invest the necessary effort" on a 4-point Likert scale anchored by 1(not at all true)-4( exactly true),the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.'}, {'measure': 'Change in parent satisfaction as assessed by the Parenting Sense of Competence Scale (PSOC)', 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'The PSOC is a 17-item scale and each item is rated on a 6-point Likert scale anchored by 1(strongly disagree to 6( strongly agree).A higher score indicates a higher parenting sense of competency'}, {'measure': "Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Infant", 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'DECA (Infant) is a 33 item questionnaire for parents about their infants (1mont-18 months) It is a 5 point behavior rating scale scored from never to very frequently which provides an assessment of within-child protective factors central to social and emotional health and resilience.'}, {'measure': "Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Toddler", 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'DECA (Toddler) is a 36 item questionnaire. It is a 5 point behavior rating scale scored from never to very frequently which provides an assessment of within-child protective factors central to social and emotional health and resilience.'}, {'measure': "Change in children's behavior as assessed by the Devereux Early Childhood Assessments (DECA)-Preschoolers", 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'DECA (preschoolers) is a 38 item questionnaire. It is a 5 point behavior rating scale scored from never to very frequently which provides an assessment of within-child protective factors central to social and emotional health and resilience.'}, {'measure': 'Change in perceived parent child connectedness as assessed by the Mothers Object Relational Scale- Short Form (MORS- SF) and MORS- Child scale.', 'timeFrame': 'Baseline, 1 month post intervention, 3 months post intervention', 'description': 'this is a 14 item scale and each item is scored from 0( never)-5(always)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positive parenting', 'Women experiencing homelessness', 'Inter-personal violence'], 'conditions': ['Positive Parenting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to strengthen the skills and self-efficacy of women by addressing the social and emotional trauma that they have experienced from inter-personal violence (IPRV) and homelessness and to promote positive parenting strategies through Play and Learning Strategies (ePALS), an evidence based intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women's report of physical, sexual or psychological abuse from a partner/ family member/ acquaintance/ stranger within the last 24 months\n* have at least one child under the age of 5 years old\n\nExclusion Criteria:\n\n* non-English speaking\n* physical presence of a male partner at the time of enrollment"}, 'identificationModule': {'nctId': 'NCT05139251', 'briefTitle': 'Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Positive Parenting: Empowering Young Mothers Experiencing Homelessness With a History of Inter-personal Violence to Improve Parenting Strategies', 'orgStudyIdInfo': {'id': 'HSC-SN-21-0869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS', 'interventionNames': ['Other: Recovering from Intimate partner violence through Strengths and Empowerment (RISE)', 'Other: ePALS']}], 'interventions': [{'name': 'Recovering from Intimate partner violence through Strengths and Empowerment (RISE)', 'type': 'OTHER', 'description': 'RISE intervention will be implemented for a period of 4 weeks at the beginning of the program. Four components/modules of the RISE intervention which includes a) education on health effects of violence, b) improving coping and self-care, c) enhancing social support, and d) addressing sexual violence will be used. Toward the beginning of each session the participant will complete a brief survey including a 10-item general self-efficacy scale to be graphed and discussed together to provide more immediate feedback to women about their progress, and at times, inform module selection. At the conclusion of each RISE session, women are asked to set a goal related to the topic in consultation with the clinician', 'armGroupLabels': ['Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS']}, {'name': 'ePALS', 'type': 'OTHER', 'description': "Participants and their children will then receive 6 weekly sessions of ePALS. The ePALS sessions include rapport building, recognizing and understanding children's signals, contingently responding to signals, labeling objects and actions, learning book reading strategies, maintaining children's focus of attention, helping children with self-regulation, and language scaffolding techniques. Each parent will have a personal parenting coach who remotely supports their progress through the program.\n\nAfter a parent views a PALS coaching session, they will videotape themselves trying the strategy for that week with their child. Then their coach sets up a zoom call and together they talk about the PALS strategy and view the video. The coach facilitates parental appraisal of their behavior and discuss what they thought worked with their child and what they want to do differently.", 'armGroupLabels': ['Recovering from Intimate partner violence through Strengths and Empowerment (RISE) +ePALS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Doncy Eapen, PhD, RN, FNP-BC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Doncy Eapen', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}