Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06408818
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2024-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tscull@irtinc.us', 'phone': '9194937700', 'title': 'Dr. Tracy Scull', 'organization': 'innovation Research and Training'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from pretest to posttest completion: approximately 4 weeks.', 'description': 'Participants were grouped as dyads for the purposes of recruitment and analyses. Therefore, parent and child were grouped when reporting adverse events. Notably, there were no adverse events to report in any dyads, including among both parents and children.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.', 'otherNumAtRisk': 196, 'deathsNumAtRisk': 196, 'otherNumAffected': 0, 'seriousNumAtRisk': 196, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.', 'otherNumAtRisk': 194, 'deathsNumAtRisk': 194, 'otherNumAffected': 0, 'seriousNumAtRisk': 194, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Frequency of Parent-child Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.18', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will respond to questions about the frequency with which their parent has talked with them about 12 topics related to prepubescent health on a Likert-type scale \\[1 = Never; 2 = A little; 3 = A lot\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Parent Report of Frequency of Parent-child Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.42', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent will respond to questions about the frequency with which they have talked with their child about 12 topics related to prepubescent health on a Likert-type scale \\[1 = Never; 2 = A little; 3 = A lot\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of General Parent-child Communication Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will indicate the extent to which they agree with nine statements about communication with their parent on a Likert-type scale \\[1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Parent Report of General Parent-child Communication Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.08', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent will indicate the extent to which they agree with nine statements about communication with their child on a Likert-type scale \\[1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Active Parental Media Mediation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.46', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '3.69', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child\'s perception of parent\'s use of active media mediation will be assessed using two items (e.g., "How often does your parent tell you what they see in media is different than real life?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Parent Report of Active Parental Media Mediation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.17', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parents\' use of active media mediation will be assessed using two items (e.g., "How often do you tell your child what they see in media is different than real life?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Parental Restrictive Media Mediation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child\'s perception of parent\'s use of restrictive media mediation will be assessed using one item (e.g., "How often does your parent limit the amount of your screen time (watching shows, going online, playing video games, or using social media)?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\]. Higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Parent Report of Parental Restrictive Media Mediation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.88', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent\'s use of restrictive media mediation will be assessed using one item (e.g., "How often do you limit the amount of your child\'s screen time (watching shows, going online, playing video games, or using social media)?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\].\n\nHigher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Awareness of Family Media Rules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.96', 'groupId': 'OG000'}, {'value': '90.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'NUMBER', 'timeFrame': 'Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will indicate on one item whether their family has rules about media use. Response options are "yes (1)," "no (0)," and "unsure (2)". Yes (1) indicates a more favorable outcome.', 'unitOfMeasure': 'percentage of participants with "1"', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted using multiple imputed data. Therefore, the percentage values will not yield a whole participant because results are pooled between 50 imputations.'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Parent Report of Awareness of Family Media Rules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.88', 'groupId': 'OG000'}, {'value': '92.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.79', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'NUMBER', 'timeFrame': 'Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent will indicate on one item whether their family has rules about media use. Response options are "yes (1)," "no (0)," and "unsure (2)". Yes (1) indicates a more favorable outcome.', 'unitOfMeasure': 'percentage of participants w/ "1"', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted using multiple imputed data. Therefore, the percentage values will not yield a whole participant because results are pooled between 50 imputations.'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Acceptance of Gender Stereotypical Roles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.86', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will respond to the 7 items to indicate their agreement with statements about gender using a 5-point Likert scale (1 = "disagree a lot" to 5 = "agree a lot"). Reponses on items are averaged, and higher scores indicate a less favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Attitudes Toward Puberty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will respond to one item (i.e., "I like the fact that I am becoming a woman/man") on a 4-point scale from 1 = disagree a lot to 4 = Agree a lot to assess participants\' attitudes towards puberty. Higher scores indicate a more favorable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Pretest in Child Report of Body-esteem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'OG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.32', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': "Child will respond to four statements about how they feel about their body (e.g., I'm proud of my body) on a 5-point scale \\[1 = Never; 2 = Seldom; 3 = Sometimes; 4 = Often; 5 =Always\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'FG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Total participants completed pretest (parent and child)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'Parent Completed Pretest', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Child Completed Pretest', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Parent Completed Posttest', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Child Completed Posttest', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'comment': 'Total participants completed posttest (parent and child)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.\n\nMedia Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.'}, {'id': 'BG001', 'title': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.\n\nActive Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Parents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.79', 'spread': '6.89', 'groupId': 'BG000'}, {'value': '40.98', 'spread': '6.72', 'groupId': 'BG001'}, {'value': '40.89', 'spread': '6.79', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.87', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '10.55', 'spread': '1.07', 'groupId': 'BG001'}, {'value': '10.71', 'spread': '1.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One parent from each condition was missing data on parent age.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Parent Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Parent Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}, {'title': 'Parent Non-binary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Child Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Child Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': 'Child Non-binary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Data for one child was missing in Intervention group.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Parent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The overall sample size includes parents and children combined. The demographics were broken out by parent and child.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Parents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The overall sample size includes parents and children combined. The demographics were broken out by parent and child.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Parents and children who were eligible and completed pretest. (Intervention included 98 parent-child pairs and control included 97 parent-child pairs)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-22', 'size': 160610, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-04T10:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2024-05-07', 'resultsFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-24', 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Pretest in Child Report of Frequency of Parent-child Communication', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will respond to questions about the frequency with which their parent has talked with them about 12 topics related to prepubescent health on a Likert-type scale \\[1 = Never; 2 = A little; 3 = A lot\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Parent Report of Frequency of Parent-child Communication', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent will respond to questions about the frequency with which they have talked with their child about 12 topics related to prepubescent health on a Likert-type scale \\[1 = Never; 2 = A little; 3 = A lot\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of General Parent-child Communication Quality', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will indicate the extent to which they agree with nine statements about communication with their parent on a Likert-type scale \\[1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Parent Report of General Parent-child Communication Quality', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent will indicate the extent to which they agree with nine statements about communication with their child on a Likert-type scale \\[1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of Active Parental Media Mediation', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child\'s perception of parent\'s use of active media mediation will be assessed using two items (e.g., "How often does your parent tell you what they see in media is different than real life?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Parent Report of Active Parental Media Mediation', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parents\' use of active media mediation will be assessed using two items (e.g., "How often do you tell your child what they see in media is different than real life?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of Parental Restrictive Media Mediation', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child\'s perception of parent\'s use of restrictive media mediation will be assessed using one item (e.g., "How often does your parent limit the amount of your screen time (watching shows, going online, playing video games, or using social media)?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\]. Higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Parent Report of Parental Restrictive Media Mediation', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent\'s use of restrictive media mediation will be assessed using one item (e.g., "How often do you limit the amount of your child\'s screen time (watching shows, going online, playing video games, or using social media)?"). Participants will rate items on a 5-point Likert scale \\[1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often\\].\n\nHigher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of Awareness of Family Media Rules', 'timeFrame': 'Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will indicate on one item whether their family has rules about media use. Response options are "yes (1)," "no (0)," and "unsure (2)". Yes (1) indicates a more favorable outcome.'}, {'measure': 'Change From Pretest in Parent Report of Awareness of Family Media Rules', 'timeFrame': 'Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Parent will indicate on one item whether their family has rules about media use. Response options are "yes (1)," "no (0)," and "unsure (2)". Yes (1) indicates a more favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of Acceptance of Gender Stereotypical Roles', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will respond to the 7 items to indicate their agreement with statements about gender using a 5-point Likert scale (1 = "disagree a lot" to 5 = "agree a lot"). Reponses on items are averaged, and higher scores indicate a less favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of Attitudes Toward Puberty', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': 'Child will respond to one item (i.e., "I like the fact that I am becoming a woman/man") on a 4-point scale from 1 = disagree a lot to 4 = Agree a lot to assess participants\' attitudes towards puberty. Higher scores indicate a more favorable outcome.'}, {'measure': 'Change From Pretest in Child Report of Body-esteem', 'timeFrame': 'Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)', 'description': "Child will respond to four statements about how they feel about their body (e.g., I'm proud of my body) on a 5-point scale \\[1 = Never; 2 = Seldom; 3 = Sometimes; 4 = Often; 5 =Always\\]. Reponses on items are averaged, and higher scores indicate a more favorable outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preadolescent Health', 'Media Literacy', 'Parent-Child Communication', 'Gender Stereotypes', 'Body-Image', 'Puberty', 'Sexual Health', 'Relationship Health'], 'conditions': ['Parenting', 'Parent-Child Relations', 'Communication']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn if Media Aware Parent - Tween, an online program for parents of children ages 9-12, helps parents have effective conversations with their child about health and media.', 'detailedDescription': 'Parent-child pairs (N=300 pairs) will be recruited to participate in a randomized controlled trial. Parent consent and parent permission and youth assent will be sought. Participant pairs will be randomized into one of two study arms: intervention and active control. All participants will complete a web-based pre-test questionnaire. Youth and parents will then receive access to their randomly assigned resource. Approximately four weeks after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The adult must be the legal guardian of a child ages 9 to 12 years old.\n* The parent must be able and willing to receive email and text communication as part of the study.\n* The parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone.\n* The parent-child pair must be fluent in English as the study materials are written in English.\n* The parent must indicate that they will give the child participant privacy to complete the questionnaires.\n* Both the adult and child must agree to participate.\n\nExclusion Criteria:\n\n* Only one parent-child pair per family may participate in the study. If the parent has more than one child aged 9 to 12 that is willing to participate, the parent will be prompted to select the child participant based on the following: if the parent's last name begins with a letter from A to M, select the youngest eligible child willing to participate or if the parent's last name begins with a letter from N to Z, select the oldest eligible child willing to participate.\n* In an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study."}, 'identificationModule': {'nctId': 'NCT06408818', 'briefTitle': 'Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships', 'organization': {'class': 'OTHER', 'fullName': 'Innovation Research & Training'}, 'officialTitle': 'Online Parent Media Literacy Program to Promote Preadolescent Health', 'orgStudyIdInfo': {'id': 'TweenHealthStudy-R21-23-006-01'}, 'secondaryIdInfos': [{'id': '5R21HD108440-02', 'link': 'https://reporter.nih.gov/quickSearch/5R21HD108440-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Program: Media Aware Parent -Tween', 'description': 'Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.', 'interventionNames': ['Behavioral: Media Aware Parent - Tween']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control Resource', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.', 'interventionNames': ['Behavioral: Active Control Resource']}], 'interventions': [{'name': 'Media Aware Parent - Tween', 'type': 'BEHAVIORAL', 'description': 'Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.', 'armGroupLabels': ['Intervention Program: Media Aware Parent -Tween']}, {'name': 'Active Control Resource', 'type': 'BEHAVIORAL', 'description': 'Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.', 'armGroupLabels': ['Active Control Resource']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'innovation Research and Training', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovation Research & Training', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}