Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder

Noncompliance Clinical Trial

— PCIT  

Official title:

Efficacy of Parent-Child Interaction Therapy With ASD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088905
• Other study ID #: 0031588
• Secondary ID: PRO023120445
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: July 2016

Study information

• Verified date: March 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months to 83 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Noncompliance

Intervention

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.

Locations

Country	Name	City	State
United States	Merck Child Outpatient Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Autism Speaks

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eyberg Child Behavior Inventory	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.	Week 9
Primary	Eyberg Child Behavior Inventory	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.	Week 18
Secondary	Parental Stress Index-4 Short Form	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.	Week 18
Secondary	Social Responsiveness Scale 2 Score	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.	Week 9
Secondary	Social Responsiveness Scale 2 Score	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.	Week 18
Secondary	Dyadic Parent-Child Interaction Coding System Scores	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.	Week 9
Secondary	Dyadic Parent-Child Interaction Coding System Scores	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.	Week 18
Secondary	Parental Stress Index Score	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.	Week 9