NCT03331016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

October 6, 2017

Last Update Submit

September 25, 2019

Conditions

Sexual BehaviorConflict, FamilyPregnancy RelatedSexually Transmitted DiseasesFamily and Household

Keywords

Foster caregiverKinship caregiverFoster youthUnintended pregnancyCurriculumInterventionsexually transmitted infectionsBehaviorismMonitoringCommunicationAdolescent developmentsexually transmitted diseases

Outcome Measures

Primary Outcomes (7)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

Study Arms (2)

Waitlist Control Group

OTHER

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

EXPERIMENTAL

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

Behavioral: Heart to Heart Training

Interventions

Heart to Heart TrainingBEHAVIORAL

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.

Intervention GroupWaitlist Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pasadena City College

Pasadena, California, 91106, United States

Location

Los Angeles Mission College

Sylmar, California, 91342, United States

Location

Related Publications (1)

  • 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.

    PMID: 34992327DERIVED

MeSH Terms

Conditions

Sexual BehaviorSexually Transmitted DiseasesCommunication

Condition Hierarchy (Ancestors)

BehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized stepped wedge design with waitlist controls
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2017

First Posted

November 6, 2017

Study Start

August 2, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(2)