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

Primary Purpose

Development Delay, Behavior Problem

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BPT-M

BPT-E

About this trial

This is an interventional treatment trial for Development Delay focused on measuring intervention, behavioral parent training, mindfulness-based stress reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Loma Linda University
University of Oregon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BPT-E

BPT-M

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change from baseline to post-treatment in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.

Parents and teachers report on child behavior using the Child Behavior Checklist-Ages 1.5-5 years (Achenbach, 2000) and the Caregiver/ Teacher Report Form (Achenbach, 2000), respectively. The total behavior problems T-score from each form is used to assess externalizing and internalizing behavior problems. Verbal and physical disruptive behavior and noncompliance are noted using our observation systems (Phaneuf & McIntyre, 2007; Jabson & Dishion, 2004, 2005). These sources of information will be used to build a "child behavior problem" latent construct. Our criteria for including an indicator in a construct are as follows: The items comprising the indicator must show internal consistency (>.60; item-total correlation > .20), and the scale or indicator convergence in SEM must meet acceptable fit criteria; a comparative fit index and Tucker-Lewis or nonnormed fit index <.95, root mean square error of approximation < .06, and standardized root mean square residual < .08.

Change from baseline to 6-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.

Change from baseline to 12-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.

Secondary Outcome Measures

Change from baseline to post-treatment in parenting behavior, assessed by parent self-report and and observer ratings.

Parents report on their parenting behavior using the Parenting Practices Inventory (The Incredible Years, 2015). Parents' positive behavior support and behavior management, as well as parent-child relationship quality, are noted using our observation systems (Phaneuf & McIntyre, 2007; Jabson & Dishion, 2004, 2005). These sources of information will be used to build a "parenting behavior" latent construct. See our criteria for including an indicator in a construct in the description of Outcome 1.

Change from baseline to 6-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings.

Change from baseline to 12-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings.

Change from baseline to post-treatment in parenting stress, assessed by parent self-report.

Parents report on three forms of stress. General distress in the parenting role is assessed using the parental distress subscale of the Parenting Stress Index-Fourth Edition, Short Form (PSI4-SF; Abidin, 1995). The Negative Impact scale of the Family Impact Questionnaire (Donenberg & Baker, 1993) is used to assess stress specific to the child with DD. The intensity subscale of the Parenting Daily Hassles questionnaire (Crnic & Greenberg, 1990) assesses parents' perceived intensity of daily stressors related to caregiving demands. These sources of information will be used to build a "parenting stress" latent construct. See our criteria for including an indicator in a construct in the description of Outcome 1.

Change from baseline to 6-month follow-up in parenting stress, assessed by parent self-report.

Change from baseline to 12-month follow-up in parenting stress, assessed by parent self-report.

Full Information

NCT ID

NCT03599648

First Posted

July 11, 2018

Last Updated

October 2, 2023

Sponsor

University of Oregon

Collaborators

Loma Linda University

1. Study Identification

Unique Protocol Identification Number

NCT03599648

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

September 14, 2018 (Actual)

Primary Completion Date

July 18, 2023 (Actual)

Study Completion Date

July 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oregon

Collaborators

Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Development Delay, Behavior Problem

Keywords

intervention, behavioral parent training, mindfulness-based stress reduction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

212 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BPT-E

Arm Type

Experimental

Arm Description

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.

Arm Title

BPT-M

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

BPT-M

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

BPT-E

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline to post-treatment in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.

Description

Time Frame

immediately after 16 week intervention

Title

Change from baseline to 6-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.

Description

Time Frame

6 months after intervention is completed

Title

Change from baseline to 12-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings.

Description

Time Frame

12 months after intervention is completed

Secondary Outcome Measure Information:

Title

Change from baseline to post-treatment in parenting behavior, assessed by parent self-report and and observer ratings.

Description

Time Frame

immediately after 16 week intervention

Title

Change from baseline to 6-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings.

Description

Time Frame

6 months after intervention is completed

Title

Change from baseline to 12-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings.

Description

Time Frame

12 months after intervention is completed

Title

Change from baseline to post-treatment in parenting stress, assessed by parent self-report.

Description

Time Frame

immediately after 16-week intervention

Title

Change from baseline to 6-month follow-up in parenting stress, assessed by parent self-report.

Description

Time Frame

6 months after intervention is completed

Title

Change from baseline to 12-month follow-up in parenting stress, assessed by parent self-report.

Description

Time Frame

12 months after intervention is completed

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura L McIntyre, PhD

Organizational Affiliation

University of Oregon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loma Linda University

City

Loma Linda

State/Province

California

ZIP/Postal Code

92350

Country

United States

Facility Name

University of Oregon

City

Portland

State/Province

Oregon

ZIP/Postal Code

97209

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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