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Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder (PCIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088905
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

Brief Summary:

The aim of the current proposal is to determine if the PCIT treatment manual can be successfully utilized for preschoolers with ASD and disruptive behavior (across a range of intellectual functioning levels) and to evaluate its ability to significantly decrease measures of problem behavior. It is hypothesized that the current manual will require few modifications for use with ASD and that, in comparison to a wait-list control group, families who undergo PCIT training will evidence significant gains on measures of parenting stress, child externalizing behaviors and compliance to parental requests. To address the pilot study aims, we will recruit a total of 25 families of children with ASD (ages 2.6-6.11 years) whose children are already receiving intensive, one-on-one behavioral treatment services (15-30 hours per week) but no structured parent training. Families will be randomized to either intensive services + PCIT or intensive services alone (wait list control). Assessments will be completed at baseline, mid-treatment (9 weeks post baseline), post-treatment (18 weeks after the baseline assessment) and long-term follow-up (12 weeks post-treatment). PCIT families will attend 16 weekly, one-hour coaching sessions. Both active treatment and wait-list control families will continue to receive intensive ABA services in the home or community. Control families will receive PCIT training after 18 weeks on the "wait-list." The aims of the pilot study are:

  1. To assess the utility of the current PCIT treatment manual with preschoolers with ASD and disruptive behavior and their parents;

    Hypothesis 1: The current PCIT treatment manual will be able to be utilized with families of children with ASD with only minimal modifications.

    Hypothesis 2: Families of children with ASD will consistently attend PCIT sessions.

  2. To determine if PCIT with this population will result in an increase in appropriate parent behaviors and a subsequent decrease in targeted child behaviors (e.g., direct assessment of noncompliance, behavior rating scales).

Hypothesis 3: Families receiving PCIT training will evidence statistically greater decreases on measures of disruptive behavior, quality of parent-child interactions and parental stress than families on the wait-list control group.


Condition or disease Intervention/treatment Phase
Noncompliance Behavioral: Parent Child Interaction Therapy Not Applicable

Detailed Description:
Young children with ASD often present with a range of externalizing behavior problems, including aggression, tantrums and difficulty transitioning. Interventions based on the principles of applied behavior analysis (ABA) have been shown to offer an effective means of addressing many of these concerns. Parent-Child Interaction Therapy (PCIT) is a manualized, empirically supported parent coaching intervention that has been found to be highly effective for typically developing preschoolers presenting with a range of mental health concerns. It also holds considerable promise as a potentially effective treatment for children with ASD. The focus of PCIT treatment is to both improve parent-child interactions and to reduce child behavior problems. PCIT involves the coaching of parents in real-time, via a one-way mirror and a "bug-in-the ear" device that allows the therapist to provide feedback and directions to the parent while interacting with his/her child. The aim of the current proposal is to determine if the PCIT treatment manual can be successfully utilized for preschoolers with ASD and to evaluate its ability to significantly decrease measures of problem behavior. It is hypothesized that the current manual will require few modifications for use with ASD and that, in comparison to a wait-list control group, families who undergo PCIT training will evidence significant gains on measures of parenting stress, child externalizing behaviors and compliance to parental requests. To address the pilot study aims, we will recruit a total of 25 families of children with ASD (ages 2.6-6 years) whose children are already receiving intensive, one-on-one behavioral treatment services (15-30 hours per week). Families will be randomized to either intensive services + PCIT or intensive services alone (wait list control). Assessments will be completed at baseline, mid-treatment (9 weeks post baseline) and post-treatment (18 weeks after the baseline assessment). PCIT families will attend 20 weekly, one-hour coaching sessions. Both active treatment and wait-list control families will continue to receive intensive ABA services in the home or community. The results of this study will provide pilot data in a subsequent application for federal funding to conduct larger controlled trials, including examining the use of PCIT in school-age children with ASD and intellectual disability and to assess the individual and combined efficacy of PCIT and psychopharmacological treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Parent-Child Interaction Therapy With ASD
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Parent Child Interaction Therapy
Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group
Behavioral: Parent Child Interaction Therapy
Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.

No Intervention: Wait list control
Families will wait 18 weeks for treatment, serving as controls.



Primary Outcome Measures :
  1. Eyberg Child Behavior Inventory [ Time Frame: Week 9 ]

    Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 9.

    The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always).

    Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors.

    The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).

    Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.


  2. Eyberg Child Behavior Inventory [ Time Frame: Week 18 ]

    Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 18

    The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always).

    Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors.

    The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).

    Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors.



Secondary Outcome Measures :
  1. Parental Stress Index-4 Short Form [ Time Frame: Week 18 ]

    Parental Stress Index-4 Short Form (PSI) is comprised of several subscales that are independently measured and also combined to create a total score. Scores are calculated from 36 questions that rated as Strongly Agree/Agree/Not Sure/Disagree/Strongly Disagree by the parents. Ratings are attached to a 5-point Likert scale.

    PSI Defensive Responding subscale range: 7-35. Lower scores indicate higher defensive responding from parents.

    For the PSI Parental Distress subscale, range 12-60. Higher scores indicate higher parental stress in the parenting.

    For the PSI Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting.

    For the PSI Difficult Child subscale, range 12-60. Higher scores indicates parents view their child to be difficult to parent.

    For PSI Total Stress, range 43-215. Higher scores indicate higher stress.


  2. Social Responsiveness Scale 2 Score [ Time Frame: Week 9 ]
    Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.

  3. Social Responsiveness Scale 2 Score [ Time Frame: Week 18 ]
    Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.

  4. Dyadic Parent-Child Interaction Coding System Scores [ Time Frame: Week 9 ]

    The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child-lead play, then parent-lead play, and then clean-up.

    Positive Skills score is the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.

    Negative skills score is a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up.


  5. Dyadic Parent-Child Interaction Coding System Scores [ Time Frame: Week 18 ]

    The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child lead play, then parent lead play, and then clean-up.

    Positive Skills score was the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.

    Negative skills score was a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up.


  6. Parental Stress Index Score [ Time Frame: Week 9 ]
    Parental Stress Index-4 Short Form (PSI):Total Stress Scale, total of subscales, range 36-180, higher indicating more parental stress. Defensive Responding, range 7-35. Lower scores indicate higher defensive responding from parents. Parental Distress, range 12-60. Higher scores indicate more parental stress. Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting. Difficult Child, range is 12-60. Higher scores indicate that parents view their child to be difficult to parent.



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Ages Eligible for Study:   30 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i. Outpatients between 2 years, 6 months and 6 years, 11 months of age; ii. Diagnosis of Autistic Disorder, Pervasive Developmental Disorder Not Otherwise Specified, or Asperger's Disorder based upon the Autism Diagnostic Observation Schedule and clinical evaluation by Diagnostic and Statistical Manual of Mental Disorders IV criteria; iii. Males and females; iv. Mental Age>30 months based upon the Stanford-Binet V or Mullens [to insure that the child possesses enough expressive language to offer opportunities for the parent to learn "verbal reflection" skills and that child is able to understand time out]; v. Eyberg Child Behavior Inventory score greater than or equal to 120; vi. Behavior Assessment System for Children Externalizing Problem Scale T-score >65; vii. Care provider who can reliably bring subject to clinic visits, can attend weekly PCIT sessions, can provide trustworthy ratings and interact with subject on a regular basis.

Exclusion Criteria:

i. Unstable use of psychotropic medications (no changes in dose for at least two months and no plans to change dose during the course of the study); ii. Unstable use of dietary supplements (e.g., casein-gluten free diet)(no changes in supplement dose for at least two months and no plans to change douse during the course of the study); iii. Prior involvement in PCIT or currently receiving parent training. iv. Extremely severe behavioral concerns that require immediate treatment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088905


Locations
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United States, Pennsylvania
Merck Child Outpatient Clinic
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
University of Pittsburgh
Autism Speaks
Investigators
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Principal Investigator: Benjamin L Handen, PhD University of Pittsburgh
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Responsible Party: Benjamin L Handen, PhD, BCBA-D, Assoicate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02088905    
Other Study ID Numbers: 0031588
PRO023120445 ( Other Identifier: University of Pittsburgh IRB )
First Posted: March 17, 2014    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh:
PCIT, autism, parent training, noncompliance