Crisis Prevention Arm for Autism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism+1 MoreCrisis Prevention Arm - Other
Eligibility
3 - 17
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Autism
  • Behavioral Problem

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: baseline, 4 weeks, 8 weeks

Week 8
Change in Aberrant Behavior Checklist scores
Change in Me as a Parent Scale scores
Change in Mental Health Crisis Assessment Scale-Revised scores
Change in The Crisis Prevention Index scores

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Crisis Prevention Arm
1 of 2
Control
1 of 2

Active Control

Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Crisis Prevention Arm · Has Placebo Group · N/A

Crisis Prevention Arm
Other
ActiveComparator Group · 1 Intervention: Crisis Prevention Arm · Intervention Types: Other
Control
Other
PlaceboComparator Group · 1 Intervention: Control · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 weeks, 8 weeks

Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
82 Previous Clinical Trials
24,438 Total Patients Enrolled
Luther Kalb, PhDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

Age 3 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are the parent or guardian of a child with autism.
You are within the specified age range of 3 to 17 years old.
You must have had active medical or mental health care within the last six months.
The child must possess an MCAS-R Acuity score no greater than 19.
Caregivers must demonstrate a low level of potential crisis, as indicated by scoring 13 or lower on the Crisis Prevention Index.
The child must demonstrate certain problematic behaviors (e.g., aggression, property destruction, elopement, tantrums) as specified on section 2 of the MCAS-R.