A Primary Prevention Trial to Strengthen Child Attachment in a Native Community (FPT PFR)

University of Washington

Status: Completed

Conditions: Parent-child Interaction

Treatments: Behavioral: PFR Group; Behavioral: Resource & Referral Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02139332

STUDY00010153

5R01NR014153-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 2 patient groups

Resource & Referral group

Active Comparator group

Description:

Individuals randomized to the control group will receive a resource \& Referral service immediately after their baseline research visit.

Treatment:

Behavioral: Resource & Referral Group

PFR Group

Experimental group

Description:

Individuals randomized to the Immediate group will receive the intervention program immediately after completing the baseline assessment.

Treatment:

Behavioral: PFR Group