Clinical trial NCT03106636: Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers (KEEP-P)
Official title: Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Keywords: Preschool-aged
Foster children
child welfare
Fostercare
Parent training
early adversity
curriculum based
early intervention
preschool
foster placement disruptions
manualized intervention
group based intervention
high-risk children
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Oregon Social Learning Center
First posted: 2017-04-10
Enrollment: 442
Sex: ALL
Minimum age (years): 30
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Preschool and Kindergarten Behavior Scales (PKBS)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Observed Level of Child Inhibitory Control Via Delay Choice Paradigm
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Dimensional Change Card Sort (DCCS)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Observed Level of Child Inhibitory Control Via Bear/Dragon Task
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Observed Level of Child Working Memory Via Spin the Pots Task
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Silly Animal Categories
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Philip A Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
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