Heart to Heart: Testing a Sexual Health Training for Foster and Kinship Caregivers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Heart to Heart is a brief pregnancy prevention training program delivered to foster and kinship caregivers to prevent unintended pregnancy in foster youth. The training delivers easy to understand information on sexual health, contraception, and adolescent development. It also includes a brief behavioral training, and information on effective communication, monitoring strategies, and social support. The curriculum was piloted in Los Angeles. Investigators will test the intervention in a randomized control trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mid-life Women: Preventing Unintended Pregnancy and STIs

NCT02330133

Reproductive Health

COMPLETED PHASE2

Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings

NCT05796687

Teen Pregnancy

RECRUITING NA

Study of Time to Pregnancy in Normal Fertility

NCT00161395

Fertility Pregnancy

COMPLETED PHASE2

Louisville Teen Pregnancy Prevention Project

NCT01411878

Pregnancy Sexually Transmitted Diseases

COMPLETED NA

Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success

NCT03311061

Teen Pregnancy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Dr. Ahrens and her team will evaluate the effectiveness of this training using a randomized stepped wedge study design with a target enrollment of 100 foster and kinship caregivers. Recruitment will be carried out in collaboration with the Los Angeles Department of Child and Family Services, foster family agencies and support groups. After completing a baseline survey, participants will be randomly assigned to either the intervention group or the waitlist control group. (With a target 1:1 ratio of controls to intervention subjects, but in consideration of greater levels of attrition in the waitlist control group due to the 6-month wait before being offered the training, participants will be randomized in a ratio of 4:3 to control vs intervention group). The intervention group will receive the training soon after enrollment, and will then complete 3 follow-up surveys over the following 6 months. Participants assigned to the waitlist control group will first complete 3 surveys over 6 months, receive the intervention at the 6 month mark, then take 3 follow-up surveys over the following 6-month period. Dr. Ahrens and team will use these survey data to measure the effectiveness of the training based on the outcome measures. Participants will be surveyed at multiple timepoints both because the different outcomes are expected to occur within different time intervals (e.g. knowledge may change right away, while behaviors will take longer), and to assess whether these outcomes change over time (e.g. whether knowledge gained in the training is lasting).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Behavior Conflict, Family Pregnancy Related Sexually Transmitted Diseases Family and Household

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized stepped wedge design with waitlist controls

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Waitlist Control Group

Waitlist Control Group will serve as control group for 6 months, receiving no intervention during that time but completing periodic surveys to assess outcomes among controls (knowledge, attitudes, behaviors). They will also later receive the intervention (training program) and be followed for 6 more months.

Group Type OTHER

Heart to Heart Training

Intervention Type BEHAVIORAL

Training for foster and kinship caregivers on sexual health and how to effectively communicate with and monitor youth in their care, with the aim of reducing unintended pregnancies and sexually transmitted infections in this youth population.

Intervention Group

Intervention Group will receive the intervention (training program) right away, then will be followed for 6 months.

Group Type EXPERIMENTAL

Heart to Heart Training

Intervention Type BEHAVIORAL

Training for foster and kinship caregivers on sexual health and how to effectively communicate with and monitor youth in their care, with the aim of reducing unintended pregnancies and sexually transmitted infections in this youth population.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heart to Heart Training

Training for foster and kinship caregivers on sexual health and how to effectively communicate with and monitor youth in their care, with the aim of reducing unintended pregnancies and sexually transmitted infections in this youth population.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Is a foster or kinship caregiver in Los Angeles County.
* Has a youth age 11-21 who has lived with them for at least 3 months in the past year.
* Anticipates that at least one youth age 11-21 will continue to live with them for the next 12 months.
* Is available for either training group (immediate or in 6 months).

Exclusion Criteria

* Does not anticipate youth will stay in their home for 12 months
* Does not have a youth age 11-21 in their home
* Cannot commit to being randomized to either training group.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes