CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 959 enrolled
Drug / intervention
BPT-M +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03599648
NCT03599648N/ACompleted

Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay

University of Oregon·interventional·Posted Jul 26, 2018·Updated Mar 11, 2025

In Brief

A clinical study evaluating BPT-M and BPT-E for Development Delay and Behavior Problem. Completed, enrolled 959 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 26, 2018
Enrollment StartSep 14, 2018
Primary CompletionJul 18, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.9 years ago

Interventions

BPT-Mbehavioral

Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life. The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills.

BPT-Ebehavioral

Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources.