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

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ClinicalTrials.gov Identifier: NCT03599648
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Loma Linda University
Information provided by (Responsible Party):
Laura Lee McIntyre, University of Oregon

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date January 4, 2019
Actual Study Start Date  ICMJE September 14, 2018
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Change from baseline to post-treatment in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings. [ Time Frame: immediately after 16 week intervention ]
    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. [ Time Frame: 6 months after intervention is completed ]
    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 12-month follow-up in child behavior problems, assessed using multiple reporters, including parents and teachers, as well as observer ratings. [ Time Frame: 12 months after intervention is completed ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Change from baseline to post-treatment in parenting behavior, assessed by parent self-report and and observer ratings. [ Time Frame: immediately after 16 week intervention ]
    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. [ Time Frame: 6 months after intervention is completed ]
    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 12-month follow-up in parenting behavior, assessed by parent self-report and and observer ratings. [ Time Frame: 12 months after intervention is completed ]
    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 post-treatment in parenting stress, assessed by parent self-report. [ Time Frame: immediately after 16-week intervention ]
    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. [ Time Frame: 6 months after intervention is completed ]
    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 12-month follow-up in parenting stress, assessed by parent self-report. [ Time Frame: 12 months after intervention is completed ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pro-Parenting Study: Helping Parents Reduce Behavior Problems in Preschool Children With Developmental Delay
Official Title  ICMJE Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Development Delay
  • Behavior Problem
Intervention  ICMJE
  • 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.

  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: BPT-E

    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.

    Intervention: Behavioral: BPT-E
  • Experimental: BPT-M

    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: Behavioral: BPT-M
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allison S Caruthers, PhD 855-774-6050 ascaru@uoregon.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03599648
Other Study ID Numbers  ICMJE R01HD093667-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura Lee McIntyre, University of Oregon
Study Sponsor  ICMJE University of Oregon
Collaborators  ICMJE Loma Linda University
Investigators  ICMJE
Principal Investigator: Laura L McIntyre, PhD University of Oregon
PRS Account University of Oregon
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP