Beginning Relationships in a Native Community
- Conditions
- Parent-child Interaction
- Interventions
- Behavioral: Wait-List groupBehavioral: Immediate Group
- Registration Number
- NCT02091804
- 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/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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wait-List group Wait-List group Individuals randomized to the control group will receive the intervention program immediately after their 3-month research visit. Immediate Group Immediate Group Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.
- 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 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")
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
Trial Locations
- Locations (1)
Nimiipuu Health Community Clinic
🇺🇸Lapwai, Idaho, United States