Clinical trial NCT02088905: Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder
Official title: Efficacy of Parent-Child Interaction Therapy With ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noncompliance
Keywords: PCIT, autism, parent training, noncompliance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2014-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: Week 9
measure: Eyberg Child Behavior Inventory
timeFrame: Week 18
Secondary outcomes:
measure: Parental Stress Index-4 Short Form
timeFrame: Week 18
measure: Social Responsiveness Scale 2 Score
timeFrame: Week 9
measure: Social Responsiveness Scale 2 Score
timeFrame: Week 18
measure: Dyadic Parent-Child Interaction Coding System Scores
timeFrame: Week 9
measure: Dyadic Parent-Child Interaction Coding System Scores
timeFrame: Week 18
measure: Parental Stress Index Score
timeFrame: Week 9
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Merck Child Outpatient Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Benjamin L Handen, PhD
role: PRINCIPAL_INVESTIGATOR
References: