- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06408818
Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships
Online Parent Media Literacy Program to Promote Preadolescent Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27713
- innovation Research and Training
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The adult must be the legal guardian of a child ages 9 to 12 years old.
- The parent must be able and willing to receive email and text communication as part of the study.
- 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.
- The parent-child pair must be fluent in English as the study materials are written in English.
- The parent must indicate that they will give the child participant privacy to complete the questionnaires.
- Both the adult and child must agree to participate.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Program: Media Aware Parent -Tween
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.
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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.
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Active Comparator: Active Control Resource
Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.
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Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Pretest in Child Report of Frequency of Parent-child Communication
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Parent Report of Frequency of Parent-child Communication
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of General Parent-child Communication Quality
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Parent Report of General Parent-child Communication Quality
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of Active Parental Media Mediation
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Parent Report of Active Parental Media Mediation
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of Parental Restrictive Media Mediation
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Parent Report of Parental Restrictive Media Mediation
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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]. Higher scores indicate a more favorable outcome. |
Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of Awareness of Family Media Rules
Time Frame: Posttest (about four weeks after pretest questionnaire completion)
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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.
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Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Parent Report of Awareness of Family Media Rules
Time Frame: Posttest (about four weeks after pretest questionnaire completion)
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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.
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Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of Acceptance of Gender Stereotypical Roles
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of Attitudes Toward Puberty
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Change From Pretest in Child Report of Body-esteem
Time Frame: Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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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.
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Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TweenHealthStudy-R21-23-006-01
- 5R21HD108440-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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