Clinical trial NCT03331016: Heart to Heart: Testing a Sexual Health Training for Foster and Kinship Caregivers
Official title: Evaluating the Effectiveness of a Sexual Health Curriculum for Foster and Kinship Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Conflict, Family
Pregnancy Related
Sexually Transmitted Diseases
Family and Household
Keywords: Foster caregiver
Kinship caregiver
Foster youth
Unintended pregnancy
Curriculum
Intervention
sexually transmitted infections
Behaviorism
Monitoring
Communication
Adolescent development
sexually transmitted diseases
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized stepped wedge design with waitlist controls
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Sexual Health Knowledge Scale (adapted from Sexual Knowledge and Attitude Test for Adolescents by Fullard, Scheier, & Lief, 2005)
timeFrame: 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).
measure: Parental Monitoring Scale (Stattin & Kerr, 2000)
timeFrame: 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).
measure: Parenting Outcome Expectancy Scale
timeFrame: 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).
measure: Conflict Behavior Questionnaire (Robin & Foster, 1989)
timeFrame: 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).
measure: Media Communication and Monitoring (non-validated scale)
timeFrame: 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).
measure: Barriers to Talking about Sex (non-validated scale)
timeFrame: 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).
measure: Sexual Communication Behaviors Scale (adapted from Dutra, Miller, Forehand, 1999)
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Pasadena City College
state: California
city: Sylmar
country: United States
facility: Los Angeles Mission College
state: California
Study officials:
References:
citation: 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.