The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay

NCT03599648 | Completed Results DMC

• 1 other identifier: R01HD093667-01A1
• Study Type: interventional
• Target: 959
• Locations: 1 country
• Sites: 2

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.

Conditions

Development Delay; Behavior Problem

Keywords

intervention; behavioral parent training; mindfulness-based stress reduction

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Child Behavior Problems (Parent Report)

  Parents report on child behavior using the Child Behavior Checklist-Ages 1.5-5 years (Achenbach, 2000), a 99-item questionnaire that assesses behavioral problems in young children. Parents were asked to rate how accurately each item described their child's behavior over the past 2 months using a 3-pt scale (0=not true/ 1= somewhat or sometimes true/ 2= very true or often true). A Total Behavior Problems score was derived by taking the sum of all 99 items, with a possible range of 0-198. A high score indicates greater problem behavior.

  baseline, immediately after 16-week intervention, 6 months, 12 months

Secondary Outcomes (2)

• Change From Baseline in Parenting Behavior (Parent Report)

  baseline, immediately after 16-week intervention, 6 months, 12 months

• Change From Baseline in Parenting Stress (Parent Self-Report)

  baseline, immediately after 16-week intervention, 6 months, 12 months

Study Arms (3)

BPT-E

EXPERIMENTAL

Behavioral parent training (BPT) plus a psychoeducation program. Includes a 10-week standard BPT, plus a 6-week psychoeducation program delivered prior to the standard BPT.

Behavioral: BPT-E

BPT-M

EXPERIMENTAL

Behavioral parent training (BPT) plus mindfulness-based stress reduction (MBSR). Includes a 10-week standard BPT, plus a 6-week MBSR delivered prior to the standard BPT.

Behavioral: BPT-M

Teachers

NO INTERVENTION

At each wave of data collection, caregivers in both conditions were asked to identify a teacher who could provide an evaluation of their child's behavior outside the home. Participating teachers completed a brief 2-page questionnaire about the child.

Interventions

BPT-M BEHAVIORAL

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-M

BPT-E BEHAVIORAL

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.

BPT-E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead
• Loma Linda University: collaborator

Study Sites (2)

Loma Linda University

Loma Linda, California, 92350, United States

Location

University of Oregon

Portland, Oregon, 97209, United States

Location

MeSH Terms

Conditions

Learning Disabilities; Mental Disorders

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Results Point of Contact

• Title: Dr. Laura Lee McIntyre
• Organization: University of Oregon

llmcinty@uoregon.edu

541-346-7452

Study Officials

• Laura L McIntyre, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Dean, College of Education

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 26, 2018
• Study Start: September 14, 2018
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: March 11, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)