Clinical trial NCT03537261: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Parent Training
Aggressive Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Crisis Prevention Institute
First posted: 2018-05-25
Enrollment: 81
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score
timeFrame: Baseline and 2-weeks
Secondary outcomes:
measure: Change in the Parent Stress Index - Short Form Total Score
timeFrame: Baseline and 2-weeks
measure: Change in the Family Quality of Life Scale Total Score
timeFrame: Baseline and 2-weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lurie Center for Autism
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lisa Nowinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: