Skip to content

Beginning Relationships in a Native Community

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02091804
Acronym
P20-RP3
Enrollment
34
Registered
2014-03-19
Start date
2014-09-30
Completion date
2018-05-31
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parent-child Interaction

Keywords

Attachment theory, Parent- child relationship, Child mental health, Behavioral health

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.

Interventions

BEHAVIORALImmediate 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.

BEHAVIORALWait-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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Washington State University
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 monthsBaseline, 3-month and 6-month follow-upsWe 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.

Secondary

MeasureTime frameDescription
Change in Caregiver helplessness from baseline at 3 months and 6 monthsBaseline, 3-month and 6-month follow-upsCaregiver 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)
Change in Caregiver stress from baseline at 3 months and 6 monthsBaseline, 3-month and 6-month follow-upsCaregiver 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.
Change in Child Social-emotional Competence from baseline at 3 months and 6 monthsBaseline, 3-month and 6-month follow upsChildren's social-emotional competencies are measured with the Infant-Toddler Social Emotional Assessment, a caregiver-report questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026