Beginning Relationships in a Native Com… | Clinical Trial

Key information

Conditions

Parent-child Interaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nimiipuu Health Community Clinic

Lapwai, Idaho, 83540, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

--Caregiver is

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.

Treatment and study plan

Immediate Group

Behavioral

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

Behavioral

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.

Primary outcomes

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

Time frame: Baseline, 3-month and 6-month follow-ups

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.

Secondary outcomes

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

Time frame: Baseline, 3-month and 6-month follow-ups

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")
Change in Caregiver stress from baseline at 3 months and 6 months

Time frame: Baseline, 3-month and 6-month follow-ups

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.
Change in Child Social-emotional Competence from baseline at 3 months and 6 months

Time frame: Baseline, 3-month and 6-month follow ups

Children's social-emotional competencies are measured with the Infant-Toddler Social Emotional Assessment, a caregiver-report questionnaire

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Washington State University

Registry information

Official study title

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

Acronym: P20-RP3

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2018
First posted: Mar 19, 2014
Registry last updated: Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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