Efficacy of Parent-Child Interaction Therapy With Autism Spectrum Disorder
Noncompliance
Bottom Line
View on ClinicalTrials.gov: NCT02088905 ↗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
| Outcome | Result | p-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
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
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.