Clinical Trials Directory

Trials / Completed

CompletedNCT03106636

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
442 (actual)
Sponsor
University of Oregon · Academic / Other
Sex
All
Age
30 Months – 6 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALKEEP-PThe 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.
BEHAVIORALKEEP-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.

Timeline

Start date
2014-05-20
Primary completion
2018-10-01
Completion
2018-10-01
First posted
2017-04-10
Last updated
2020-07-14
Results posted
2020-07-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03106636. Inclusion in this directory is not an endorsement.