A Primary Prevention Trial to Strengthen Child Attachment in a Native Community (FPT PFR)

August 27, 2021 updated by: Cathryn Booth-LaForce, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Eagle Butte, South Dakota, United States, 57625
        • MBIRI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary caregiver for a child aged 10 to 30 months
  2. Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
  3. Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
  4. Caregiver has telephone access
  5. Caregiver is willing to have researchers come to their house
  6. Caregiver is English speaking
  7. 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

  1. Hospitalized or imprisoned
  2. Living in a Treatment facility or shelter
  3. Unable to give consent
  4. Live in a household that already has a dyad enrolled in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resource & Referral group
Individuals randomized to the control group will receive a resource & Referral service immediately after their baseline research visit.
Behavioral: Resource & Referral Group
The 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.
Experimental: PFR Group
Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.
Behavioral: PFR Group
The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3-month and 6-month follow-ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Caregiver helplessness from baseline at 3 months and 6 months
Time Frame: Baseline, 3-month and 6-month follow-ups
Caregiver helplessness is measured by the Caregiving Helplessness Questionnaire, comprising 45 items specific to interactions with the child. We evaluate 2 subscales for this study: Mother-Child Frightened and Mother Helplessness ("mother" is changed to "caregiver")
Baseline, 3-month and 6-month follow-ups
Change in Caregiver stress from baseline at 3 months and 6 months
Time Frame: Baseline, 3-month and 6-month follow-ups
Caregiver stress is measured by the Parenting Stress Index/Short Form, a 36-item questionnaire with 3 subscales: caregiver distress, caregiver-child dysfunctional interaction, and difficult child.
Baseline, 3-month and 6-month follow-ups
Change in Child Social-emotional Competence from baseline at 3 months and 6 months
Time Frame: Baseline, 3-month and 6-month follow ups
Children's social-emotional competencies are measured with the Infant-Toddler Social Emotional Assessment, a caregiver-report questionnaire
Baseline, 3-month and 6-month follow ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Cathryn Booth-LaForce, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00010153
  • 5R01NR014153-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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