CPI Training for Parents of Children With ASD

NCT03537261 | Completed Results

• 1 other identifier: 2018P000119
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Autism Spectrum Disorder

Keywords

Parent Training; Aggressive Behavior

Outcome Measures

Primary Outcomes (1)

• Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score

  The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy and a positive change indicating improvement from baseline. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.

  Baseline and 2-weeks

Secondary Outcomes (2)

• Change in the Parent Stress Index - Short Form Total Score

  Baseline and 2-weeks

• Change in the Family Quality of Life Scale Total Score

  Baseline and 2-weeks

Study Arms (2)

CPI-Parent Training

EXPERIMENTAL

Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.

Behavioral: Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)

Waitlist Control

NO INTERVENTION

Will not receive active P-CPI training during the experimental treatment interval. NOTE: The waitlist group will be offered the P-CPI training session after the treatment group completes their follow-up measures.

Interventions

Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) BEHAVIORAL

Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.

Also known as: (P-CPI)

CPI-Parent Training

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Crisis Prevention Institute: collaborator

Study Sites (1)

Lurie Center for Autism

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Aggression

Interventions

cyclopropapyrroloindole

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Lisa Nowinski, PhD
• Organization: Massachusetts General Hospital Lurie Center

lnowinski@mgh.harvard.edu

781-860-1700

Study Officials

• Lisa Nowinski, PhD

  Massachusetts General Hospital

  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: Director, Neuropsychology Training

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: August 8, 2018
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Locations

US (1)