A Primary Prevention Trial to Strengthen Child Attachment in a Native Community

Not Applicable

Completed

• Conditions: Parent-child Interaction
• Interventions: Behavioral: PFR Group; Behavioral: Resource & Referral Group

• Registration Number: NCT02139332
• Lead Sponsor: University of Washington

Brief Summary

The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Study Start: 2015-06
• Primary Completion: 2019-03
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFR Group	PFR Group	Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.
Resource & Referral group	Resource & Referral Group	Individuals randomized to the control group will receive a resource \& Referral service immediately after their baseline research visit.

Primary Outcome Measures

Name	Time	Method
Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months	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 Outcome Measures

Name	Time	Method
Change in Caregiver stress from baseline at 3 months and 6 months	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	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
Change in Caregiver helplessness from baseline at 3 months and 6 months	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")

Trial Locations

Locations (1)

MBIRI; 🇺🇸 Eagle Butte, South Dakota, United States