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CPI Training for Parents of Children With ASD

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Parent Training, Aggressive Behavior

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lurie Center for Autism

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPI-Parent Training

Waitlist Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 15, 2018
Last Updated
June 7, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Crisis Prevention Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03537261
Brief Title
CPI Training for Parents of Children With ASD
Official Title
Crisis Prevention Institute (CPI) Verbal and Physical Management Training for Parents of Children With ASD (P-CPI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Crisis Prevention Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Parent Training, Aggressive Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPI-Parent Training
Arm Type
Experimental
Arm Description
Will receive one-day (6-hour) training in P-CPI including the use of nonverbal, paraverbal, verbal, and physical intervention techniques.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)
Other Intervention Name(s)
(P-CPI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score
Description
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.
Time Frame
Baseline and 2-weeks
Secondary Outcome Measure Information:
Title
Change in the Parent Stress Index - Short Form Total Score
Description
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.
Time Frame
Baseline and 2-weeks
Title
Change in the Family Quality of Life Scale Total Score
Description
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.
Time Frame
Baseline and 2-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Nowinski, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurie Center for Autism
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States

12. IPD Sharing Statement

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CPI Training for Parents of Children With ASD

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