Clinical trial NCT06579781: Evaluation of Parent Toolkit 2.0 (Morehouse Family Health Study)
Official title: Rigorous Evaluation of Morehouse School of Medicine's Parent Toolkit 2.0 Intervention (Morehouse Family Health Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Behavior
Adolescent Behavior
Sexually Transmitted Diseases
Contraception Behavior
Parent-Child Relations
Keywords: teen pregnancy
STIs
parent-teen communication
parenting
adolescent sexual health
Lead sponsor: Child Trends
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria for Adult Participants:

* 25 to 70 years old
* Lives in an eligible zip code in Georgia
* Parent or caregiver of 12- to 15-year-old child who wants to participate in this study with them
* Lives with child at least 50% of the time

Exclusion Criteria for Adult Participants:

* Lives in a home with a child who is already enrolled in this study
* Raises child with an adult who is already enrolled in this study

Inclusion Criteria for Child Participants:

* 12-15 years old
* Lives with a parent or caregiver who wants to participate in this study with them
* Able to complete surveys on own or with help of support person

Exclusion Criteria for Child Participants:

- Does not have their own email address or phone number

Primary outcomes:
measure: No recent penile-vaginal or oral sex
timeFrame: 9 months after end of program
Secondary outcomes:
measure: No recent penile-vaginal sex
timeFrame: 9 months after end of program
measure: Never had penile-vaginal sex
timeFrame: 9 months after end of program
measure: Never had penile-vaginal or oral sex
timeFrame: 9 months after end of program
measure: Protected penile-vaginal sex or no penile-vaginal sex
timeFrame: 9 months after end of program
measure: Parent-child communication
timeFrame: Immediately after end of program and 9 months after end of program
measure: Parent-child relationship closeness
timeFrame: Immediately after end of program and 9 months after end of program
measure: Self-efficacy to avoid sex and to use contraceptives
timeFrame: Immediately after end of program and 9 months after end of program
measure: Emotional wellbeing
timeFrame: Immediately after end of program and 9 months after end of program
measure: Intention to avoid sex and to use contraceptives
timeFrame: Immediately after end of program and 9 months after end of program
Other outcomes:
Locations:
city: Cairo
country: United States
facility: Community Outreach
state: Georgia
Study officials:
affiliation: Child Trends
name: Jennifer Manlove, PhD
role: PRINCIPAL_INVESTIGATOR
References: