Clinical Trials Directory

Trials / Completed

CompletedNCT02139332

A Primary Prevention Trial to Strengthen Child Attachment in a Native Community

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
225 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPFR GroupThe intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session begins with a brief discussion and education on the target topic for that week . Then 20 minutes is spent on video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior (alternating weeks). Trained PFR specialists who are community members use the 5 "consultation strategies," labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts.
BEHAVIORALResource & Referral GroupThe Resource \& Referral program consists of 1) an initial needs assessment to determine if the enrolled family has any unmet needs (housing, financial, health, mental health, etc…), 2) a tailored resource and referral packet will be mailed to the participant with the most important referrals marked, 3) a follow-up call will be made two weeks after mailing the packet to verify that the participant has received it, and 4) a second follow-up call will be made three months after the initial session, to assess types of services actually received, barriers to receiving services, and reassessing resources needed and providing additional referrals if needed.

Timeline

Start date
2015-06-01
Primary completion
2019-03-01
Completion
2021-06-30
First posted
2014-05-15
Last updated
2021-09-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02139332. Inclusion in this directory is not an endorsement.