Clinical trial NCT02091804: Beginning Relationships in a Native Community
Official title: Promoting First Relationships: A Strengths-based Primary Prevention Project in a Native Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-child Interaction
Keywords: Attachment theory
Parent- child relationship
Child mental health
Behavioral health
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Washington State University
First posted: 2014-03-19
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow-ups
Secondary outcomes:
measure: Change in Caregiver helplessness from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow-ups
measure: Change in Caregiver stress from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow-ups
measure: Change in Child Social-emotional Competence from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow ups
Other outcomes:
Locations:
city: Lapwai
country: United States
facility: Nimiipuu Health Community Clinic
state: Idaho
Study officials:
affiliation: University of Washington
name: Cathryn Booth-LaForce, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.