CPI Training for Parents of Children With ASD

Crisis Prevention Institute (CPI) Verbal and Physical Management Training for Parents of Children With ASD (P-CPI)

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).

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)

Detailed Description

Parents of children with ASD deal with more stress, especially if their child demonstrates self-injurious and aggressive behavior. The purpose of this study is to evaluate whether "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e., P-CPI) for parents of children with ASD helps alleviate some of this stress and increase parental self-efficacy, physical management competency, and overall quality of life.

Participants who meet criteria will be randomly assigned to either the treatment group or the waitlist control group. Participants assigned to the treatment group will be invited to a 6-hour P-CPI group training session. This parent-based training in CPI's Nonviolent Crisis Intervention® will include nonverbal, paraverbal, verbal, and physical intervention techniques. Participants assigned to the waitlist group will be encouraged to continue their existing medical support, or services, as they typically would. The waitlist group will be invited to participate in the P-CPI training at the conclusion of the post-assessment period.

Baseline measures will be on the day of training for the treatment group and within five days of the P-CPI training for the waitlist group. Follow-up measures will be at 2-week, and 1, 2, and 3- month post-baseline. The treatment group will also participate in a follow-up group interview.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Lurie Center for Autism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPI-Parent Training; 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); 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.; Other Names: (P-CPI)
No Intervention: Waitlist Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Parent Stress Index - Short Form Total Score	The PSI-SF is a self-report measure of severity and domain of parenting stress which includes 36 items rated on a 5-point, Likert scale. The range of possible values for the total stress raw score is 36-180, with higher scores corresponding to greater levels of parental stress and negative change corresponding to reduced levels of parental stress. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.	Baseline and 2-weeks
Change in the Family Quality of Life Scale Total Score	The FQOL is a 25-item measure assessing families' perceptions of their satisfaction with different aspects of family quality of life. It assesses five domains: family interaction, parenting, general resources, health and safety, and support for persons with disabilities. Instructions were modified to ask about the previous two weeks instead of the previous 12 months. The range of possible values for the FQOL total score is 25-125, with higher scores corresponding to better quality of life and positive change corresponding to improved quality of life. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.	Baseline and 2-weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Crisis Prevention Institute
• Investigators: Principal Investigator: Lisa Nowinski, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Parent Training; Aggressive Behavior
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2018P000119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No