N/A
N=80
CPI Training for Parents of Children With ASD
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03537261 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score — 8.3; 2.5 units on a scale — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score |
8.3; 2.5 | 0.11 |
| SECONDARY Change in the Parent Stress Index - Short Form Total Score |
-2.7; -0.5 | 0.40 |
| SECONDARY Change in the Family Quality of Life Scale Total Score |
1.9; 1.3 | 0.72 |
Summary
The purpose of this 24-week study is to determine whether the "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e., P-CPI) is effective in increasing self-efficacy in parents of children with autism spectrum disorder (ASD).
Eligibility Criteria
Inclusion Criteria
- Each subject must be an adult caregiver/parent of a Lurie Center for Autism patient with 'patient' defined as having at minimum one visit/contact per year with any Lurie Center for Autism clinician. The patient (child):
- May be male or female.
- Must be from 5-12 years of age (inclusive).
- Must live at home.
- May have any IQ.
- Must have an ASD diagnosis per the DSM-5 checklist confirmed by expert clinician at enrollment.
- Must have a symptom severity score of 18 or greater on the ABC Irritability subscale confirmed by expert clinician at enrollment.
- The subject may have any primary language but must be comfortable speaking and reading English without translation.
- The subject must be the self-identified primary caregiver of the Lurie Center for Autism patient.
- The subject must be recommended by a Lurie Center for Autism clinician.
- The subject must be able to attend in person the maximum the training session on the specified date/time/location.
- The subject must be willing to complete the assessment measures.
- Only one subject per family may participate.
Exclusion Criteria
- The subject must not have any self-identified physical limitations or disabilities that prevent use of physical intervention techniques.
- The patient (child) of the subject must not have any compromising neurological disorders (i.e., CP, active seizures).
- The patient should not have the addition of non-drug treatment (including ABA and parent-training) for 4 weeks prior to intervention
Data sourced from ClinicalTrials.gov (NCT03537261). 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.