NCT02139332

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

May 13, 2014

Last Update Submit

August 27, 2021

Conditions

Parent-child Interaction

Keywords

Attachment theoryParent- child relationshipChild mental healthBehavioral health

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (3)

  • Change in Caregiver helplessness from baseline at 3 months and 6 months

    Baseline, 3-month and 6-month follow-ups

  • 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

Study Arms (2)

Resource & Referral group

ACTIVE COMPARATOR

Individuals randomized to the control group will receive a resource \& Referral service immediately after their baseline research visit.

Behavioral: Resource & Referral Group

PFR Group

EXPERIMENTAL

Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.

Behavioral: PFR Group

Interventions

PFR GroupBEHAVIORAL

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.

PFR Group
Resource & Referral GroupBEHAVIORAL

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.

Resource & Referral group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MBIRI

Eagle Butte, South Dakota, 57625, United States

Location

Related Publications (2)

  • Oxford M, Booth-LaForce C, Echo-Hawk A, Madesclaire O, Parrish L, Widner M, Petras A, Abrahamson-Richards T, Nelson K, Buchwald D; CATCH Project Team. Promoting First Relationships(R): Implementing a Home Visiting Research Program in Two American Indian Communities. Can J Nurs Res. 2020 Jun;52(2):149-156. doi: 10.1177/0844562120914424. Epub 2020 Mar 26.

    PMID: 32216455BACKGROUND

  • Booth-LaForce C, Oxford ML, O'Leary R, Rees J, Petras A, Buchwald DS. Implementation fidelity of the Promoting First Relationships intervention program in a Native community. Transl Behav Med. 2023 Jan 20;13(1):34-41. doi: 10.1093/tbm/ibac060.

    PMID: 36227860DERIVED

MeSH Terms

Interventions

Health Resources

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Cathryn Booth-LaForce, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 15, 2014

Study Start

June 1, 2015

Primary Completion

March 1, 2019

Study Completion

June 30, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)