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

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ClinicalTrials.gov Identifier: NCT03331016
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kym Ahrens, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Conflict, Family Pregnancy Related Sexually Transmitted Diseases Family and Household Behavioral: Heart to Heart Training Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized stepped wedge design with waitlist controls
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Effectiveness of a Sexual Health Curriculum for Foster and Kinship Caregivers
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Sexual Health Knowledge Scale (adapted from Sexual Knowledge and Attitude Test for Adolescents by Fullard, Scheier, & Lief, 2005) [ 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). ]
    Assessing caregivers' basic knowledge about sexual health via Sexual Knowledge and Attitude Test for Adolescents measure. Total score range = 0-8, higher = better.

  2. Parental Monitoring Scale (Stattin & Kerr, 2000) [ 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). ]
    Assessing the degree to which caregivers are aware of youth's whereabouts and activities. Total score range = 5-25, higher = better.

  3. Parenting Outcome Expectancy Scale [ 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). ]
    Change in parent expectations about discussing sexual health topics over time. Total score range = 6-30, higher = better.

  4. Conflict Behavior Questionnaire (Robin & Foster, 1989) [ 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). ]
    Assessing amount of conflict between caregiver and foster youth. Total score range = 20-80, higher = better.

  5. Media Communication and Monitoring (non-validated scale) [ 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). ]
    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)

  6. Barriers to Talking about Sex (non-validated scale) [ 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). ]
    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.

  7. Sexual Communication Behaviors Scale (adapted from Dutra, Miller, Forehand, 1999) [ 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). ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331016


Contacts
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Contact: Kym Ahrens, MD, MPH 206-884-1031 kym.ahrens@seattlechildrens.org
Contact: Katie Albertson 206-884-1584 katie.albertson@seattlechildrens.org

Locations
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United States, California
Pasadena City College Not yet recruiting
Pasadena, California, United States, 91106
Contact: Theresa Reed       txreed@pasadena.edu   
Los Angeles Mission College Recruiting
Sylmar, California, United States, 91342
Contact: Maria Granados, MA    818-364-7736    granadmi@lamission.edu   
Sponsors and Collaborators
Seattle Children's Hospital

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Responsible Party: Kym Ahrens, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03331016     History of Changes
Other Study ID Numbers: D-022514-S
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kym Ahrens, Seattle Children's Hospital:
sexually transmitted infections
sexually transmitted diseases
Foster caregiver
Kinship caregiver
Foster youth
Unintended pregnancy
Curriculum
Intervention
Behaviorism
Monitoring
Communication
Adolescent development

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female