NCT05681143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 30, 2022

Last Update Submit

December 29, 2023

Conditions

Autism Spectrum DisorderBehavior Problem

Keywords

autismexternalizingbehaviorcrisis

Outcome Measures

Primary Outcomes (1)

  • Change in The Crisis Prevention Index scores

    5-item, custom measure assessing caregivers perceived preparation for a crisis involving their child. Higher scores are better.

    baseline, 4 weeks, 8 weeks

Secondary Outcomes (3)

  • Change in Me as a Parent Scale scores

    baseline, 4 weeks, 8 weeks

  • Change in Mental Health Crisis Assessment Scale-Revised scores

    baseline, 4 weeks, 8 weeks

  • Change in Aberrant Behavior Checklist scores

    baseline, 4 weeks, 8 weeks

Study Arms (2)

Crisis Prevention Arm

ACTIVE COMPARATOR
Other: Crisis Prevention Arm

Control

PLACEBO COMPARATOR
Other: Control

Interventions

Crisis Prevention ArmOTHER

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.

Crisis Prevention Arm
ControlOTHER

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.

Control

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Related Publications (2)

  • 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.

    PMID: 31652032BACKGROUND

  • 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.

    PMID: 36129785BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderMental DisordersAutistic DisorderBehavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental Disorders

Study Officials

  • Luther Kalb, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 12, 2023

Study Start

February 1, 2023

Primary Completion

December 29, 2023

Study Completion

December 29, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)