Autism Spectrum DisorderNCT05681143
A Crisis Prevention Program for Youth With Autism
A study testing Crisis Prevention Arm in people with Autism Spectrum Disorder and Behavior Problem, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Behavior Problem
- What is being tested?
- Crisis Prevention Arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: A Crisis Prevention Program in Youth With Autism Spectrum Disorder
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.
Read the 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
- Being tested
- Crisis Prevention Arm, Control
- Keywords
- autism, externalizing, behavior, crisis
- Medical subject headings
- Autism Spectrum Disorder, Mental Disorders, Autistic Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Crisis Prevention Arm | Active comparator | Not described Receives: Other: Crisis Prevention Arm |
| Control | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks, 8 weeks
Secondary outcomes (3)
Change in Me as a Parent Scale scores
16-item measure assessing caregivers perceived ability to manage their child's behavior. Higher scores are better.
Measured: baseline, 4 weeks, 8 weeks
Change in Mental Health Crisis Assessment Scale-Revised scores
23-item parental report that measures crisis in two conceptually-based subscales, acuity and behavioral efficacy, reflecting both the core elements of crisis. Higher scores are worse.
Measured: baseline, 4 weeks, 8 weeks
Change in Aberrant Behavior Checklist scores
58-item measure of child behavior problems. Higher scores are worse.
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Feb 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luther Kalb, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681143
- Sponsor's protocol ID
- IRB00332878
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31652032Kalb 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.
PubMed 36129785
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crisis Prevention Program in Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05681143
- Acronym / sponsor ID
- IRB00332878
- Conditions
- Autism Spectrum Disorder, Behavior Problem
- Keywords
- autism, externalizing, behavior, crisis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisis Prevention Arm | Active comparator | Other: Crisis Prevention Arm |
| Control | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisis Prevention ArmThe 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. | Other | Crisis Prevention Arm |
| ControlThe 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. | Other | Control |
Primary outcome
Change in The Crisis Prevention Index scores
Time frame: baseline, 4 weeks, 8 weeks
5-item, custom measure assessing caregivers perceived preparation for a crisis involving their child. Higher scores are better.
3 secondary outcomes
Change in Me as a Parent Scale scores
Time frame: baseline, 4 weeks, 8 weeks
Change in Mental Health Crisis Assessment Scale-Revised scores
Time frame: baseline, 4 weeks, 8 weeks
Change in Aberrant Behavior Checklist scores
Time frame: baseline, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 31652032Vasa 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.
- Background: PubMed 36129785Kalb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luther Kalb, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Prevention Arm in people with Autism Spectrum Disorder and Behavior Problem, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Crisis Prevention Index scores (time frame: baseline, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681143, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.