NCT06579781

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Oct 2024Sep 2028

First Submitted

Initial submission to the registry

August 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2028

Last Updated

April 30, 2025

Status Verified

October 1, 2024

Enrollment Period

3.5 years

First QC Date

August 20, 2024

Last Update Submit

April 25, 2025

Conditions

Keywords

teen pregnancySTIsparent-teen communicationparentingadolescent sexual health

Outcome Measures

Primary Outcomes (1)

  • No recent penile-vaginal or oral sex

    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.

    9 months after end of program

Secondary Outcomes (9)

  • No recent penile-vaginal sex

    9 months after end of program

  • Never had penile-vaginal sex

    9 months after end of program

  • Never had penile-vaginal or oral sex

    9 months after end of program

  • Protected penile-vaginal sex or no penile-vaginal sex

    9 months after end of program

  • Parent-child communication

    Immediately after end of program and 9 months after end of program

  • +4 more secondary outcomes

Study Arms (2)

Control Condition

ACTIVE COMPARATOR

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.

Behavioral: Morehouse Family Health Study's General Health Guide

Treatment Condition

EXPERIMENTAL

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.

Behavioral: Morehouse Family Health Study's Parent Toolkit 2.0

Interventions

Parent Toolkit 2.0 is designed to equip parents and caregivers with skills to talk to their teens about sex and contraception and ultimately influence their teens' decision-making and behaviors around sex. The Georgia Campaign for Adolescent Power \& Potential (GCAPP) developed the Parent Toolkit intervention. Morehouse School of Medicine's (MSM) Health Promotion Research Center tested and adapted it through an OPA Innovation Network grant, creating Parent Toolkit 2.0.

Treatment Condition

General Health Guide provides information to parents on how to promote health in their families.

Control Condition

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • \- Does not have their own email address or phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Outreach

Cairo, Georgia, 39827, United States

RECRUITING

MeSH Terms

Conditions

Sexual BehaviorAdolescent BehaviorSexually Transmitted DiseasesContraception Behavior

Condition Hierarchy (Ancestors)

BehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsReproductive Behavior

Study Officials

  • Jennifer Manlove, PhD

    Child Trends

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Cook, MSPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 30, 2024

Study Start

October 21, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

September 29, 2028

Last Updated

April 30, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations