Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder

NCT02088905 | Completed Results

• 2 other identifiers: 0031588PRO023120445
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.To assess the utility of the current PCIT treatment manual with preschoolers with ASD and disruptive behavior and their parents;
2. 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).

Conditions

Noncompliance

Keywords

PCIT, autism, parent training, noncompliance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Parental Stress Index-4 Short Form

  Week 18

• Social Responsiveness Scale 2 Score

  Week 9

• Social Responsiveness Scale 2 Score

  Week 18

• Dyadic Parent-Child Interaction Coding System Scores

  Week 9

• Dyadic Parent-Child Interaction Coding System Scores

  Week 18

Study Arms (2)

Parent Child Interaction Therapy

EXPERIMENTAL

Families will either receive Parent Child Interaction Therapy or be placed on a wait-list control group

Behavioral: Parent Child Interaction Therapy

Wait list control

NO INTERVENTION

Families will wait 18 weeks for treatment, serving as controls.

Interventions

Parent Child Interaction Therapy BEHAVIORAL

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.

Parent Child Interaction Therapy

Eligibility Criteria

• Age: 30 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Autism Speaks: collaborator

Study Sites (1)

Merck Child Outpatient Clinic

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Patient Compliance; Autistic Disorder

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Benjamin L. Handen, PhD
• Organization: University of Pittsburgh

handenbl@upmc.edu

412-235-5445

Study Officials

• Benjamin L Handen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoicate Professor

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 17, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 22, 2019
• Results First Posted: March 1, 2019

Record last verified: 2019-03

Locations

US (1)