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Clinical Trials/NCT02139332
NCT02139332
Completed
N/A

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

University of Washington1 site in 1 country225 target enrollmentJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parent-child Interaction
Sponsor
University of Washington
Enrollment
225
Locations
1
Primary Endpoint
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cathryn Booth-LaForce

Principal Investigator

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Primary caregiver for a child aged 10 to 30 months
  • Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
  • Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
  • Caregiver has telephone access
  • Caregiver is willing to have researchers come to their house
  • Caregiver is English speaking
  • Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing

Exclusion Criteria

  • Caregiver is
  • Hospitalized or imprisoned
  • Living in a Treatment facility or shelter
  • Unable to give consent
  • Live in a household that already has a dyad enrolled in the study.

Outcomes

Primary Outcomes

Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months

Time Frame: Baseline, 3-month and 6-month follow-ups

We are using the Nursing Child Assessment Satellite Training Teaching Scales to assess quality of caregiver-child interactions. Caregivers select an activity that their child cannot perform, such as drawing, and spend up to 5 minutes teaching this activity to the child. The interaction is video-recorded and coded for the caregiver's sensitivity to cues, response to distress, and fostering of social, emotional, and cognitive growth, as well as for the child's clarity of cues and responsiveness to the caregiver.

Secondary Outcomes

  • Change in Caregiver stress from baseline at 3 months and 6 months(Baseline, 3-month and 6-month follow-ups)
  • Change in Child Social-emotional Competence from baseline at 3 months and 6 months(Baseline, 3-month and 6-month follow ups)
  • Change in Caregiver helplessness from baseline at 3 months and 6 months(Baseline, 3-month and 6-month follow-ups)

Study Sites (1)

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