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CPI Training for Parents of Children With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537261
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Crisis Prevention Institute
Information provided by (Responsible Party):
Lisa A. Nowinski, PhD, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crisis Prevention Institute (CPI) Verbal and Physical Management Training for Parents of Children With ASD (P-CPI)
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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 Name: (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.




Primary Outcome Measures :
  1. Child Adjustment and Parent Efficacy Scale-Development Disability [ Time Frame: 2-weeks ]

    Scale ranges for interpretation, with subscales:

    Item range = 0-3; Total Range for all 24 items = 0-72

    • 3 subscales:

    • Behavioral problems (10 items); Subscale score range = 0-30,
    • Emotional problems (3 items); Subscale score range = 0-9,
    • Prosocial behavior (8 items); Subscale score range = 0-24

    Outcome scoring:

    For items 1-16, higher scores indicate worse outcome. For items 17-24, higher scores indicate better outcome.

    Score computation- Items 1-16 are summed. Items 17-24 are reverse scored.



Secondary Outcome Measures :
  1. Parent Stress Index - Short Form [ Time Frame: 2-weeks ]
  2. Family Quality of Life Scale [ Time Frame: 2-weeks ]

    Scale ranges for interpretation, with subscales:

    Item range = 1-5; Total Range = 25-125

    • 5 subscales:

    • Family Interaction (6 items); Subscale score range = 6-30
    • Parenting (6 items); Subscale score range = 6-30
    • Emotional Well-being (4 items); Subscale score range = 4-20
    • Physical/Material Well-being (5 items); Subscale score range = 3-15
    • Disability-Related Support (4 items); Subscale score range = 4-20

    Outcome Scoring:

    For all items, higher scores indicate better outcomes

    Score Computation:

    Items 1-25 are summed.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537261


Locations
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United States, Massachusetts
Lurie Center for Autism
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Massachusetts General Hospital
Crisis Prevention Institute
Investigators
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Principal Investigator: Lisa Nowinski, PhD Massachusetts General Hospital
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Responsible Party: Lisa A. Nowinski, PhD, Director, Neuropsychology Training, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03537261    
Other Study ID Numbers: 2018P000119
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa A. Nowinski, PhD, Massachusetts General Hospital:
Parent Training
Aggressive Behavior
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders