Clinical trial NCT03599648: The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay
Official title: Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development Delay
Behavior Problem
Keywords: intervention
behavioral parent training
mindfulness-based stress reduction
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Loma Linda University
First posted: 2018-07-26
Enrollment: 959
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Pro-Parenting Study seeks to determine the added benefit of targeting both parenting stress and parent management strategies to more effectively reduce behavior problems among children with developmental delay (DD). Findings from this study will improve the scientific understanding of evidence-based interventions for behavior problems among children with DD and the mechanisms underlying therapeutic change.

Detailed description: Behavior problems are a common and concerning challenge among children with developmental delay (DD). Approximately 50% of children with DD have a comorbid mental disorder or serious behavior problems- a prevalence three times as high as that found in typically developing youths. Behavioral parent training (BPT) is the gold-standard intervention for treating child behavior problems in typically developing children and in children with DD. However, high levels of parental stress are associated with reduced or no response to BPT for children with DD. Consequently, parental stress may attenuate the efficacy of the gold-standard, empirically supported treatment for behavior problems among children with DD. As such, parental stress is a critical point of intervention for improving both parent and child outcomes in families of children with DD. The purpose of this study is to quantify the therapeutic benefit of adding a parent stress-reduction intervention prior to delivering BPT in order to more effectively reduce child behavior problems, and to investigate the mechanisms through which intervention outcomes occur.

Eligibility criteria: Inclusion Criteria:

* Parent has a child ages 3 to 5 years with an agency-identified DD in one or more functional areas who is receiving early intervention or early childhood/ preschool special education through an individualized family service plan (IFSP) or individualized education plan (IEP);
* Parent reports elevated child behavior problems, as indicated by a T-score of 60 or above on the Total Problems scale of the Child Behavior Checklist;
* Parent reports elevated parenting stress, as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4.

Exclusion Criteria:

* Parent screens positive for active psychosis, substance abuse, or suicidality;
* Parent is currently receiving any form of psychological or behavioral treatment at the time of referral; or
* The child has sensory impairments or nonambulatory conditions that would necessitate the need for significant modifications to the lab and home visit protocols.

Primary outcomes:
measure: Change From Baseline in Child Behavior Problems (Parent Report)
timeFrame: baseline, immediately after 16-week intervention, 6 months, 12 months
Secondary outcomes:
measure: Change From Baseline in Parenting Behavior (Parent Report)
timeFrame: baseline, immediately after 16-week intervention, 6 months, 12 months
measure: Change From Baseline in Parenting Stress (Parent Self-Report)
timeFrame: baseline, immediately after 16-week intervention, 6 months, 12 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Portland
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Laura L McIntyre, PhD
role: PRINCIPAL_INVESTIGATOR
References: