N/A N=416 Randomized Single-blind Prevention

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

Child Behavior

Bottom Line

View on ClinicalTrials.gov: NCT03106636 ↗

Enrolled (actual)

416

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form — 80.87; 86.18; 74.62; 80.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: KEEP-P (Behavioral); KEEP-P+ (Behavioral)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Oregon
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Parenting Stress Via Self-report Measure Parenting Stress Index IV (PSI-IV) Short Form	80.87; 86.18; 74.62; 80.8; -5.29; -5.72	—
PRIMARY Caregiver's Perceived Sense of Competency in Parenting Via Self-report Measure Parent Sense of Competency Scale (PSOC)	49.42; 49.82; 51.6; 50.15; 2.14; 0.3	—
PRIMARY Observed Level of Developmentally-supportive Parenting Via Observational Measure Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)	42.58; 43.36; 42.85; 43.08; 0.14; -0.76	—
PRIMARY Frequency of Family Routines Via Self-report Measure Family Routines Questionnaire (FRQ)	51.66; 50.43; 52.63; 52.09; 1.37; 1.3	—
PRIMARY Mindful Parenting Via Self-report Measure Interpersonal Mindfulness in Parenting (IEMP)	37.87; 37.17; 38.8; 37.56; 0.81; 0.69	—
PRIMARY Child Attachment Behaviors Via Caregiver-report Measure Attachment Diary (ADRY)	7.53; 8.42; 7.75; 7.87; 0.22; -0.49	—
PRIMARY Child Internalizing/Externalizing Symptoms and Total Behavior Score Via Caregiver-report Measure Child Behaviour Checklist (CBCL)	59.6; 61.65; 57.18; 57.47; -3.24; -3.76	—
PRIMARY Preschool and Kindergarten Behavior Scales (PKBS)	55.86; 54.63; 50.6; 52.39; -3.44; -3.09	—
PRIMARY Parental Stress Via Caregiver-report Measure Parent Daily Report (PDR)	6.56; 7.26; 4.48; 4.58; -1.9; -2.8	—
PRIMARY Child Social-emotional Development Via Caregiver-report Measure Ages and Stages Questionnaire: Social-Emotional (ASQ:SE)	121.35; 125.81; 105; 119.13; -14.33; -2.39	—
PRIMARY Observed Level of Child Inhibitory Control Via Delay Choice Paradigm	4.86; 5.55; 5.24; 4.54; 0.19; -0.89	—
PRIMARY Dimensional Change Card Sort (DCCS)	1.76; 1.61; 2.12; 2.05; 0.48; 0.43	—
PRIMARY Observed Level of Child Inhibitory Control Via Bear/Dragon Task	21.52; 20.42; 23.6; 22.42; 1.56; 3.24	—
PRIMARY Observed Level of Child Working Memory Via Spin the Pots Task	0.58; 0.55; 0.62; 0.59; 0.05; 0.06	—
PRIMARY Silly Animal Categories	0.64; 0.61; 0.67; 0.71; 0.05; 0.1	—
PRIMARY Child Executive Function Via Kansas Reflection-Impulsivity Scale for Preschoolers (KRISP)	35.76; 33.52; 37.81; 35.8; 2.16; 3.96	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03106636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.