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

Behavior Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599648
• Other study ID #: R01HD093667-01A1
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: July 18, 2023

Study information

• Verified date: August 2023
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior Problem
• Development Delay
• Problem Behavior

Intervention

Behavioral:
• BPT-M
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-E
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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California
United States	University of Oregon	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after 16 week intervention
Primary	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.	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.	6 months after intervention is completed
Primary	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.	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.	12 months after intervention is completed
Secondary	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.	immediately after 16 week intervention
Secondary	Change from baseline to 6-month follow-up 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.	6 months after intervention is completed
Secondary	Change from baseline to 12-month follow-up 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.	12 months after intervention is completed
Secondary	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.	immediately after 16-week intervention
Secondary	Change from baseline to 6-month follow-up 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.	6 months after intervention is completed
Secondary	Change from baseline to 12-month follow-up 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.	12 months after intervention is completed