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

Primary Purpose

Sexual Behavior, Conflict, Family, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart to Heart Training
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Behavior focused on measuring Foster caregiver, Kinship caregiver, Foster youth, Unintended pregnancy, Curriculum, Intervention, sexually transmitted infections, Behaviorism, Monitoring, Communication, Adolescent development, sexually transmitted diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pasadena City College
  • Los Angeles Mission College

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Waitlist Control Group

Intervention Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
Parenting Outcome Expectancy Scale
Change in parent expectations about discussing sexual health topics over time. Total score range = 6-30, higher = better.
Conflict Behavior Questionnaire (Robin & Foster, 1989)
Assessing amount of conflict between caregiver and foster youth. Total score range = 20-80, higher = better.
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2017
Last Updated
September 25, 2019
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03331016
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized stepped wedge design with waitlist controls
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist Control Group
Arm Type
Other
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention Group will receive the intervention (training program) right away, then will be followed for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Heart to Heart Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sexual Health Knowledge Scale (adapted from Sexual Knowledge and Attitude Test for Adolescents by Fullard, Scheier, & Lief, 2005)
Description
Assessing caregivers' basic knowledge about sexual health via Sexual Knowledge and Attitude Test for Adolescents measure. Total score range = 0-8, higher = better.
Time Frame
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).
Title
Parental Monitoring Scale (Stattin & Kerr, 2000)
Description
Assessing the degree to which caregivers are aware of youth's whereabouts and activities. Total score range = 5-25, higher = better.
Time Frame
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).
Title
Parenting Outcome Expectancy Scale
Description
Change in parent expectations about discussing sexual health topics over time. Total score range = 6-30, higher = better.
Time Frame
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).
Title
Conflict Behavior Questionnaire (Robin & Foster, 1989)
Description
Assessing amount of conflict between caregiver and foster youth. Total score range = 20-80, higher = better.
Time Frame
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).
Title
Media Communication and Monitoring (non-validated scale)
Description
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)
Time Frame
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).
Title
Barriers to Talking about Sex (non-validated scale)
Description
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.
Time Frame
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).
Title
Sexual Communication Behaviors Scale (adapted from Dutra, Miller, Forehand, 1999)
Description
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.
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pasadena City College
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
Los Angeles Mission College
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
34992327
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.
Results Reference
derived

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

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