A Crisis Prevention Program for Youth With Autism

NCT ID: NCT05681143

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-29

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.

Conditions

Autism Spectrum Disorder; Behavior Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Crisis Prevention Arm

Group Type: ACTIVE_COMPARATOR

Crisis Prevention Arm

Intervention Type: OTHER

The crisis prevention program involves a 3-session model. Each session lasts up to 60 minutes. They take place via telehealth with a licensed clinical therapist. Sessions involve case formulation, provision of prevention strategies, connecting with professional and lay resources, what to do if a crisis occurs, and strategies to prevent the re-occurrence of a crisis, should one occur. Each session involves use of checklists, a community resource guide, and homework. Implementation is standardized using two different manuals, one for the parent and the other for the provider.

Control

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

The control condition will involve sending families the Autism Speaks Challenging Behavior Toolkit. It offers a complimentary set of recommendations. It is freely available and can be found here: https://www.autismspeaks.org/tool-kit/challenging-behaviors-tool-kit. There is no interaction with the clinician in the controlcondition. After the study observation period, we will provide them with the crisis manual (for parents) used in the active treatment arm.

Interventions

Crisis Prevention Arm

The crisis prevention program involves a 3-session model. Each session lasts up to 60 minutes. They take place via telehealth with a licensed clinical therapist. Sessions involve case formulation, provision of prevention strategies, connecting with professional and lay resources, what to do if a crisis occurs, and strategies to prevent the re-occurrence of a crisis, should one occur. Each session involves use of checklists, a community resource guide, and homework. Implementation is standardized using two different manuals, one for the parent and the other for the provider.

Intervention Type: OTHER

Control

The control condition will involve sending families the Autism Speaks Challenging Behavior Toolkit. It offers a complimentary set of recommendations. It is freely available and can be found here: https://www.autismspeaks.org/tool-kit/challenging-behaviors-tool-kit. There is no interaction with the clinician in the controlcondition. After the study observation period, we will provide them with the crisis manual (for parents) used in the active treatment arm.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luther Kalb, PhD

Role: PRINCIPAL_INVESTIGATOR

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31652032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36129785 (View on PubMed)

Other Identifiers

IRB00332878

Identifier Type: -

Identifier Source: org_study_id