Evaluation of Parent Toolkit 2.0 (Morehouse Family Health Study)

Not Applicable

Recruiting

• Conditions: Sexual Behavior; Adolescent Behavior; Sexually Transmitted Diseases; Contraception Behavior; Parent-Child Relations
• Interventions: Behavioral: Morehouse Family Health Study's General Health Guide; Behavioral: Morehouse Family Health Study's Parent Toolkit 2.0

• Registration Number: NCT06579781
• Lead Sponsor: Child Trends

Brief Summary

Child Trends will conduct a randomized control trial evaluation of Parent Toolkit 2.0, an innovative intervention for parents and caregivers of middle and high school students. Child Trends will collaborate with Morehouse School of Medicine and Tressa Tucker \& Associates, LLC to implement and evaluate the program with 1,000 parent-teen pairs across Georgia. The program includes three components that will be delivered across a three-week period: (1) an online self-paced Parent Guide with information, tips, tools, and resources on adolescent health, including sexual health; (2) four videos modeling parent-teen communication around sex and contraception; and (3) two group-based sessions for parent participants to discuss program content and improve communication skills. The program aims to increase parent knowledge and parent-teen communication about adolescent health, sexual health, and relationships to help youth adopt health-promoting behaviors such as delaying sexual initiation and increasing contraceptive use.

Detailed Description

Child Trends, in partnership with the Morehouse School of Medicine (MSM), will implement Parent Toolkit 2.0. The Georgia Campaign for Adolescent Power \& Potential developed the Parent Toolkit intervention and Morehouse School of Medicine's (MSM) Health Promotion Research Center tested and adapted it through an OPA Innovation Network grant.

Child Trends plans to conduct an individual randomized controlled trial (RCT) to evaluate the effectiveness of Parent Toolkit 2.0 in delaying sexual initiation and increasing contraceptive use among youth who engage in sexual activity. Youth outcomes are expected to improve as a result of the expansion of parental knowledge and improvement of parent-teen communication about adolescent health, sexual health, and relationships. Associated outcomes will be measured through two surveys, one of which will be distributed immediately after the intervention ends while the other will be administered nine months after the end of the intervention.

The intended population is youth ages 12-15 living in rural and micropolitan areas in central, north, and southeast Georgia, and their parents or caregivers. A "caregiver" in this context is defined as someone who lives with the child at least 50 percent of the time and who is one of the main people responsible for the child. The parents or caregivers will be the program participants since they are the intended recipients of all intervention-related resources such as the toolkit, videos, and group-based virtual sessions. By contrast, the youth enrolled in the study will not directly engage in the programming.

As a part of this study, treatment group parent/caregiver participants will be asked to:

* Review a self-paced parent guide and four videos modeling parent-teen communication on Canvas

* Attend two 1-hour group sessions with other parents

* Complete baseline and post-intervention surveys

* Participate in an optional focus group discussion

Control group parent/caregiver participants will be asked to:

* Review a self-paced parent guide on Canvas

* Complete baseline and post-intervention surveys

* Participate in an optional focus group discussion

Treatment and control group youth participants will be asked to:

* Complete baseline, post-intervention, and nine-month follow-up surveys

* Participate in an optional focus group discussion

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Status Verified: 2024-10
• Study Start: 2024-10-21
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2028-04-30
• Study Completion: 2028-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Condition	Morehouse Family Health Study's General Health Guide	Adult participants in the control condition will receive access to an online general health guide for parents that was adapted for this study from a pre-existing health guide.
Treatment Condition	Morehouse Family Health Study's Parent Toolkit 2.0	Adult participants in the treatment condition will receive access to the Parent Toolkit 2.0 intervention, which includes an online interactive guide, four videos modeling parent-teen communication around sex and contraception, and two group-based, virtual sessions with other parents and caregivers.

Primary Outcome Measures

Name	Time	Method
No recent penile-vaginal or oral sex	9 months after end of program	Yes = Has not had penile-vaginal or oral sex in past 3 months; No = Has had penile-vaginal or oral sex in past three months.

Secondary Outcome Measures

Name	Time	Method
No recent penile-vaginal sex	9 months after end of program	Yes = Has not had consensual penile-vaginal sex in past 3 months; No = Has had consensual penile-vaginal sex in past 3 months.
Never had penile-vaginal sex	9 months after end of program	Yes = Has never had consensual penile-vaginal sex; No = Has had consensual penile-vaginal sex.
Never had penile-vaginal or oral sex	9 months after end of program	Yes = Has never had consensual penile-vaginal or oral sex; No = Has had consensual penile-vaginal or oral sex.
Protected penile-vaginal sex or no penile-vaginal sex	9 months after end of program	Yes = Always used pill, shot, patch, ring, IUD, implant, or condom during penile-vaginal sex OR did not have penile-vaginal sex; No = Had penile-vaginal sex without using pill, shot, patch, ring, IUD, implant, or condom every time
Parent-child communication	Immediately after end of program and 9 months after end of program	Score of talking with parent/caregiver about important topics, such as online safety, love languages, healthy relationships, peer pressure and bullying, puberty, sexual activity, reproduction, birth control, condoms, STIs, and going to the doctor for sexual health care. Scores will range from 0 to 16, with a higher score indicating a better outcome.
Parent-child relationship closeness	Immediately after end of program and 9 months after end of program	Score of parent-child relationship, including frequency of having fun doing something with parent, having a good conversation with parent about something that matters to the youth, going to parent when the youth was feeling unhappy or needing help, resolving conflicts together with parent, and comfort talking with parent about important topics. Scores will range from 0 to 6, with a higher score indicating a better outcome.
Self-efficacy to avoid sex and to use contraceptives	Immediately after end of program and 9 months after end of program	Score of confidence in being able to not have penis-in-vagina sex if the youth does not want to and to use birth control every time youth has penile-vaginal sex. Scores will range from 0 to 6, with higher scores indicating more self-efficacy.
Emotional wellbeing	Immediately after end of program and 9 months after end of program	Score of mental health during past week, including feeling depressed or very sad, fearful, bothered by things that do not usually bother youth, trouble keeping mind on what youth is doing, that everything youth did used up a lot of their energy, hopeful about the future, hard to go to sleep or stay asleep, happy, lonely, could not get going. Scores will range from 0 to 30, with higher scores indicating better mental health.
Intention to avoid sex and to use contraceptives	Immediately after end of program and 9 months after end of program	Score of intentions to not have penis-in-vagina sex in the next year and to use (or support their partner in using) birth control during penile-vaginal sex in next year. Scores will range from 0 to 3, with higher scores indicating stronger intentions.

Trial Locations

Locations (1)

Community Outreach; 🇺🇸 Cairo, Georgia, United States