Clinical trial NCT05681143: A Crisis Prevention Program for Youth With Autism
Official title: A Crisis Prevention Program in Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Behavior Problem
Keywords: autism
externalizing
behavior
crisis
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mental health crises involve acute psychiatric states, such as aggression and/or self-injury, which can result in harm to self or others. There is evidence to suggest that 20% to 25% of autistic children are at risk of a mental health crises, however no crisis prevention programs exist for autistic children. The goal of this project is to evaluate, via a randomized design, a novel crisis prevention program.

Detailed description: When a child or adolescent experiences a mental health crisis, it is a devastating and potentially life-threating event. Beyond the hazard of injury, mental health crises can have a life-altering impact on the child (repeated trauma, development of future psychopathology), family members (increased stress and poorer well-being) and society as a whole (cost and disability). Our inability to prevent or identify those in crisis is reflected in the rising rates of suicides, extensive wait times and overcrowding in emergency departments, and the jailing of people with mental illness.

Mental health crises are defined as a) the presence of acute psychiatric symptoms that require immediate attention or intervention and b) the perceived (by the informant) lack of immediate resources to manage these symptoms. Similar to the concepts of impairment or distress, mental health crisis is a transdiagnostic construct that applies to all psychiatric problems, from self-injury to aggression to psychosis to substance abuse.

The recently developed Mental Health Crisis Assessment Scale-Revised (MCAS-R), developed by a team of expert clinical and public health researchers, was specifically designed to address the current gap in crisis measurement for autistic children. The MCAS-R is a 23-item parental report, which takes no more than 10 minutes to complete, that measures crisis in two conceptually-based subscales, acuity and behavioral efficacy, reflecting both the core elements of crisis. Based on the cutoffs, it has been shown to accurately identify crises in 9 out of 10 autistic children. Recent work suggests between 20-25% of children served in outpatient mental health are at risk of a mental health crisis, as identified by the validated MCAS cutoff.

At present, no crisis prevention programs exist for autistic children. There are certainly numerous community-based crisis intervention programs, outpatient mental health treatment approaches, and parent behavioral training programs. However, no programs exist that aim to prevent a crisis from occurring. The goal of this study is to fill this gap by providing families with tools before their child's behavior becomes acute.

The goals of this study are to examine: 1) child and parent outcomes associated with a novel crisis prevention program for autistic children; 2) gather survey-based feedback from parents, post-intervention, to understand feasibility and utility of the crisis prevention program.

Eligibility criteria: Inclusion Criteria:

* Have a child with autism
* The child must be 3-17 years of age
* Caregivers must score \<=13 on the Crisis Prevention Index (CPI)
* The child must have some behavioral concerns (e.g., aggression, property destruction, elopement, tantrums), as listed on section 2 of the MCAS-R.
* The child must have an MCAS-R Acuity score of at most 19
* The child must be actively seen by a medical or mental health professional within the last six months

Exclusion Criteria:

* The child has any suicidal thoughts or behaviors
* The child is enrolled in another treatment study
* The child is enrolled in the RUBI parent training program, offered at the Center for Autism and Related Disorders at Kennedy Krieger
* Caregivers has a hearing or language impairment
* Caregiver does not have consistent access to the internet

Primary outcomes:
measure: Change in The Crisis Prevention Index scores
timeFrame: baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Change in Me as a Parent Scale scores
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Mental Health Crisis Assessment Scale-Revised scores
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change in Aberrant Behavior Checklist scores
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Luther Kalb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vasa RA, Hagopian L, Kalb LG. Investigating mental health crisis in youth with autism spectrum disorder. Autism Res. 2020 Jan;13(1):112-121. doi: 10.1002/aur.2224. Epub 2019 Oct 25.
citation: Kalb LG, DiBella F, Jang YS, Fueyo M, Mahajan R, Vasa RA. Mental Health Crisis Screening in Youth with Autism Spectrum Disorder. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):127-135. doi: 10.1080/15374416.2022.2119984. Epub 2022 Sep 21.