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

Evaluating the Effectiveness of a Sexual Health Curriculum for Foster and Kinship Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Pregnancy Related; Sexual Behavior; Family and Household; Conflict, Family
• Intervention / Treatment: Behavioral: Heart to Heart Training

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91106
      • Pasadena City College
    • Sylmar, California, United States, 91342
      • Los Angeles Mission College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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.
Experimental: Intervention Group; Intervention Group will receive the intervention (training program) right away, then will be followed for 6 months.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Health Knowledge Scale (adapted from Sexual Knowledge and Attitude Test for Adolescents by Fullard, Scheier, & Lief, 2005)	Assessing caregivers' basic knowledge about sexual health via Sexual Knowledge and Attitude Test for Adolescents measure. Total score range = 0-8, higher = better.	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).
Parental Monitoring Scale (Stattin & Kerr, 2000)	Assessing the degree to which caregivers are aware of youth's whereabouts and activities. Total score range = 5-25, higher = better.	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).
Parenting Outcome Expectancy Scale	Change in parent expectations about discussing sexual health topics over time. Total score range = 6-30, higher = better.	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).
Conflict Behavior Questionnaire (Robin & Foster, 1989)	Assessing amount of conflict between caregiver and foster youth. Total score range = 20-80, higher = better.	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).
Media Communication and Monitoring (non-validated scale)	Change in media discussions and monitoring behaviors - 2 question questionnaire developed by Megan Moreno questions available upon request. Total score range = 5-10, higher = better)	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).
Barriers to Talking about Sex (non-validated scale)	Change in number of barriers to caregivers talking about sex with teens in their home. Questionnaire developed by research team based on focus group data.	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).
Sexual Communication Behaviors Scale (adapted from Dutra, Miller, Forehand, 1999)	Change in number of sexual health topics discussed with youth and how helpful caregivers perceive conversations to be. Total score range = 0-11, lower = better); 3 subscales: 1) Number of topics = 0-6, higher = better; 2) Frequency of communication = 0-4, higher = better; 3) Helpfulness of conversations = 1-3, higher = better.	We will assess change from baseline over 6 months in each arm (outcomes will be measured at baseline, 1 month, 3 months, and 6 months).

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Publications and helpful links

General Publications

• Ahrens KR, Udell W, Albertson K, Lowry S, Hoopes T, Coatney A. Development and two-phased pilot RCT of a foster/kinship caregiver intervention to improve sexual health communication with youth. Child Youth Serv Rev. 2021 Mar;122:105877. doi: 10.1016/j.childyouth.2020.105877. Epub 2020 Dec 25.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Monitoring; Intervention; Communication; sexually transmitted diseases; sexually transmitted infections; Unintended pregnancy; Foster caregiver; Kinship caregiver; Foster youth; Curriculum; Behaviorism; Adolescent development
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: D-022514-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators do not have specific plans to make IPD available to other researchers, but they are open to it if there is interest from other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No