NCT02091804

Brief Summary

The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control/wait list group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Maternal and Child Health 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
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.7 years

First QC Date

March 14, 2014

Last Update Submit

October 5, 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)

Wait-List group

ACTIVE COMPARATOR

Individuals randomized to the control group will receive the intervention program immediately after their 3-month research visit.

Behavioral: Wait-List group

Immediate Group

EXPERIMENTAL

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

Behavioral: Immediate Group

Interventions

Immediate GroupBEHAVIORAL

The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session lasts approximately 30 minutes, and begins with brief (\~10 min) discussions and education on the target topic for that week . The remaining 20 minutes will alternate between 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. 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.

Immediate Group
Wait-List groupBEHAVIORAL

The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session lasts approximately 30 minutes, and begins with brief (\~10 min) discussions and education on the target topic for that week . The remaining 20 minutes will alternate between 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. 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.

Wait-List 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)

Nimiipuu Health Community Clinic

Lapwai, Idaho, 83540, 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, Barbosa-Leiker C, Burduli E, Buchwald DS. Randomized Controlled Trial of the Promoting First Relationships(R) Preventive Intervention for Primary Caregivers and Toddlers in an American Indian Community. Prev Sci. 2020 Jan;21(1):98-108. doi: 10.1007/s11121-019-01053-x.

    PMID: 31754964RESULT

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
Professor, Dept. of Family and Child Nursing

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 19, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)