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N/A N=23 Randomized Treatment

Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder

Noncompliance

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Eyberg Child Behavior Inventory — 132.50; 154.33; 18.9; 19.11 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Parent Child Interaction Therapy (Behavioral)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Eyberg Child Behavior Inventory
115.20; 148.67; 14.10; 19.67 .080
PRIMARY
Eyberg Child Behavior Inventory
115.20; 148.67; 14.10; 19.67 .080
SECONDARY
Parental Stress Index-4 Short Form
17.70; 20.33; 29.10; 33.44; 28.80; 27.44 .203
SECONDARY
Social Responsiveness Scale 2 Score
80.00; 88.22; 12.40; 12.11; 14.60; 15.89 0.271
SECONDARY
Social Responsiveness Scale 2 Score
80.00; 88.22; 12.40; 12.11; 14.60; 15.89 0.271
SECONDARY
Dyadic Parent-Child Interaction Coding System Scores
22.2; 76.44; 41.4; 8.11 <.001 sig
SECONDARY
Dyadic Parent-Child Interaction Coding System Scores
22.2; 76.44; 41.4; 8.11 <.001 sig
SECONDARY
Parental Stress Index Score
18.80; 19.56; 31.30; 31.44; 31.30; 28.78

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02088905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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