Sexual BehaviorNCT06579781
Evaluation of Parent Toolkit 2.0 (Morehouse Family Health Study)
A study testing Morehouse Family Health Study's Parent Toolkit 2.0 and Morehouse Family Health Study's General Health Guide in people with Sexual Behavior and Adolescent Behavior, run by Child Trends at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Adolescent Behavior, Sexually Transmitted Diseases
- What is being tested?
- Morehouse Family Health Study's Parent Toolkit 2.0 and Morehouse Family Health Study's General Health Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 29 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Does not have their own email address or phone number
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Community Outreach
Cairo, Georgia, 39827
Tressa Tucker, PhD, (310) 625-1913, tressatuckerconsulting@comcast.net
About this study
Official title: Rigorous Evaluation of Morehouse School of Medicine's Parent Toolkit 2.0 Intervention (Morehouse Family Health Study)
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.
Read the 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
- Conditions
- Sexual Behavior, Adolescent Behavior, Sexually Transmitted Diseases, Contraception Behavior, Parent-Child Relations
- Being tested
- Morehouse Family Health Study's Parent Toolkit 2.0, Morehouse Family Health Study's General Health Guide
- Keywords
- teen pregnancy, STIs, parent-teen communication, parenting, adolescent sexual health
- Medical subject headings
- Sexual Behavior, Adolescent Behavior, Sexually Transmitted Diseases, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morehouse Family Health Study's Parent Toolkit 2.0Behavioural
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.
Morehouse Family Health Study's General Health GuideBehavioural
General Health Guide provides information to parents on how to promote health in their families.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Morehouse Family Health Study's Parent Toolkit 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months after end of program
Secondary outcomes (9)
No recent penile-vaginal sex
Yes = Has not had consensual penile-vaginal sex in past 3 months; No = Has had consensual penile-vaginal sex in past 3 months.
Measured: 9 months after end of program
Never had penile-vaginal sex
Yes = Has never had consensual penile-vaginal sex; No = Has had consensual penile-vaginal sex.
Measured: 9 months after end of program
Never had penile-vaginal or oral sex
Yes = Has never had consensual penile-vaginal or oral sex; No = Has had consensual penile-vaginal or oral sex.
Measured: 9 months after end of program
Protected penile-vaginal sex or no penile-vaginal sex
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
Measured: 9 months after end of program
Parent-child communication
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.
Measured: Immediately after end of program and 9 months after end of program
Parent-child relationship closeness
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.
Measured: Immediately after end of program and 9 months after end of program
Self-efficacy to avoid sex and to use contraceptives
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.
Measured: Immediately after end of program and 9 months after end of program
Emotional wellbeing
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.
Measured: Immediately after end of program and 9 months after end of program
Intention to avoid sex and to use contraceptives
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.
Measured: Immediately after end of program and 9 months after end of program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start21 Oct 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Child Trends
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Manlove, Child Trends
- Investigators
- Jennifer Manlove, PhD, Principal investigator, Child Trends
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579781
- Sponsor's protocol ID
- Child Trends
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigorous Evaluation of Morehouse School of Medicine's Parent Toolkit 2.0 Intervention (Morehouse Family Health Study)
- ClinicalTrials.gov ID
- NCT06579781
- Acronym / sponsor ID
- Child Trends
- Conditions
- Sexual Behavior, Adolescent Behavior, Sexually Transmitted Diseases, Contraception Behavior, Parent-Child Relations
- Keywords
- teen pregnancy, STIs, parent-teen communication, parenting, adolescent sexual health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Child TrendsUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Active comparator | Behavioral: Morehouse Family Health Study's General Health GuideAdult 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 | Experimental | Behavioral: Morehouse Family Health Study's Parent Toolkit 2.0Adult 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- 12-15 years old
Key exclusion criteria (3 listed)
- 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
- Does not have their own email address or phone number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morehouse Family Health Study's Parent Toolkit 2.0Parent 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. | Behavioural | Treatment Condition |
| Morehouse Family Health Study's General Health GuideGeneral Health Guide provides information to parents on how to promote health in their families. | Behavioural | Control Condition |
Primary outcome
No recent penile-vaginal or oral sex
Time frame: 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.
9 secondary outcomes
No recent penile-vaginal sex
Time frame: 9 months after end of program
Never had penile-vaginal sex
Time frame: 9 months after end of program
Never had penile-vaginal or oral sex
Time frame: 9 months after end of program
Protected penile-vaginal sex or no penile-vaginal sex
Time frame: 9 months after end of program
Parent-child communication
Time frame: Immediately after end of program and 9 months after end of program
Parent-child relationship closeness
Time frame: Immediately after end of program and 9 months after end of program
Self-efficacy to avoid sex and to use contraceptives
Time frame: Immediately after end of program and 9 months after end of program
Emotional wellbeing
Time frame: Immediately after end of program and 9 months after end of program
Intention to avoid sex and to use contraceptives
Time frame: Immediately after end of program and 9 months after end of program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Manlove, PhD principal investigator
Child Trends
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morehouse Family Health Study's Parent Toolkit 2.0 and Morehouse Family Health Study's General Health Guide in people with Sexual Behavior and Adolescent Behavior, run by Child Trends at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asari Offiong, PhD ((240) 223-9306, aoffiong@childtrends.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No recent penile-vaginal or oral sex (time frame: 9 months after end of program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.