Beginning Relationships in a Native Community (P20-RP3)

Promoting First Relationships: A Strengths-based Primary Prevention Project in a Native Community

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.

Study Overview

• Status: Completed
• Conditions: Parent-child Interaction
• Intervention / Treatment: Behavioral: Wait-List group; Behavioral: Immediate Group

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Lapwai, Idaho, United States, 83540
      • Nimiipuu Health Community Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wait-List group; Individuals randomized to the control group will receive the intervention program immediately after their 3-month research visit.	Behavioral: Wait-List group; 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.
Experimental: Immediate Group; Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.	Behavioral: Immediate Group; 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.

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	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	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	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	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

• Sponsor: University of Washington
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Washington State University
• Investigators: Principal Investigator: Cathryn Booth-LaForce, PhD, University of Washington

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Attachment theory; Parent- child relationship; Child mental health; Behavioral health
• Other Study ID Numbers: STUDY00001796; 1P20MD006871 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No