Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)

NCT ID: NCT03106636

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-20
• Study Completion Date: 2018-10-01

Brief Summary

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P). The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for preschoolers and their caregivers. The investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Detailed Description

Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P).

Preschool-aged foster and other high-risk children are at increased risk for numerous negative outcomes. However, there is very limited use of evidence-based interventions for these young children. Major barriers to progress in this area include a lack of available evidence-based programs for high-risk children across the preschool years and the tendency for the few existing evidence-based interventions to be resource intensive in terms of funding and the level of staff expertise required to be implemented with fidelity. Readily scalable, evidence-based interventions for foster and other high-risk preschoolers are clearly needed to reduce the widespread disparities. The goal of the proposed study is to conduct a randomized clinical trial of a new, low-cost, manualized, group-based intervention for caregivers of preschool aged children. The investigators propose to evaluate two versions of the intervention: (a) a basic version that employs a curriculum consisting of 12 weekly psychoeducational caregiver support groups and (b) an augmented version that consists of the caregiver support groups with extended curriculum including with the addition of information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development (FIND) video coaching program. Across four waves of data collection (baseline, immediately postintervention, and 12 and 18 months postbaseline), the investigators will examine the extent to which the two intervention conditions show improved parenting, reduced rates of disrupted placements, and improved child outcomes. The investigators will conduct multivariate modeling to examine mediating mechanisms underlying the hypothesized immediate and longer- term intervention effects.

Finally, the investigators will conduct a comprehensive economic evaluation to examine the incremental costs associated with implementing the intervention and the benefits realized in the intervention conditions in terms of increased positive outcomes for children.

Conditions

Child Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

KEEP-P

Caregivers are randomly assigned to one of two groups. The KEEP-P group completes a basic version of the curriculum. The intervention content is delivered by a KEEP-P group facilitator in a 2-hour weekly group format. Duration of the program is 12 weeks.

Group Type: ACTIVE_COMPARATOR

KEEP-P

Intervention Type: BEHAVIORAL

The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P is a basic version that employs a curriculum of 12 weekly psychoeducational caregiver support groups Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition shows improved parenting, reduced rates of disrupted placements, and improved child outcomes.

KEEP-P+

Caregivers are randomly assigned to one of two groups. The KEEP-P+ group completes an augmented version of the intervention with curriculum that includes the addition of information about recent findings in early brain development and a video coaching component based on the Filming Interactions to Nurture Development (FIND) program. The intervention content is delivered by a KEEP-P group facilitator in a 2-hour weekly group format. Duration of the program is 12 weeks.

Group Type: EXPERIMENTAL

KEEP-P+

Intervention Type: BEHAVIORAL

The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P+ is an augmented version that consists of the caregiver support groups with extended curriculum including information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development video coaching program. Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Interventions

KEEP-P

The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P is a basic version that employs a curriculum of 12 weekly psychoeducational caregiver support groups Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition shows improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Intervention Type: BEHAVIORAL

KEEP-P+

The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P+ is an augmented version that consists of the caregiver support groups with extended curriculum including information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development video coaching program. Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition show improved parenting, reduced rates of disrupted placements, and improved child outcomes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Preschool-aged foster children
• Preschool-aged children referred to early intervention/childhood special education services

Exclusion Criteria

• Children will be excluded from recruitment if they or their primary caregiver are not sufficiently fluent in English to complete the assessment or if it is determined that the child would not be able to complete the assessment procedures due to a severe developmental, medical, or physical disorder.

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Social Learning Center

OTHER

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Phil Fisher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip A Fisher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

University of Oregon

Eugene, Oregon, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

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Other Identifiers

06112013.016

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Identifier Source: org_study_id