An interventional study of Heart to Heart Training in Sexual Behavior, Conflict, Family and Pregnancy Related, sponsored by Seattle Children's Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Prevention
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.
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).
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's enrollment of 62 is below the median of 264 across 179 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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).
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.
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).
Parenting Outcome Expectancy Scale
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).
Conflict Behavior Questionnaire (Robin & Foster, 1989)
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).
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)
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).
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.
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).
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.
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).
Plan to share: No — 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.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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