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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331016
• Other study ID #: D-022514-S
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2019
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Pasadena City College	Pasadena	California
United States	Los Angeles Mission College	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).