N/A
N=959
The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay
Development Delay · Behavior Problem
Bottom Line
View on ClinicalTrials.gov: NCT03599648 ↗Enrolled (actual)
959
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline in Child Behavior Problems (Parent Report) — 73.60; 77.95; 71.49; 71.69 score on a scale — p=.361
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BPT-M (Behavioral); BPT-E (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oregon
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Child Behavior Problems (Parent Report) |
73.60; 77.95; 71.49; 71.69; 67.85; 70.67 | .361 |
| SECONDARY Change From Baseline in Parenting Behavior (Parent Report) |
3.85; 3.90; 4.02; 4.12; 4.10; 4.13 | .035 sig |
| SECONDARY Change From Baseline in Parenting Stress (Parent Self-Report) |
113.70; 115.28; 101.23; 100.10; 97.72; 96.89 | .000 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03599648). 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.