Autism and Disruptive Behavior Trial
Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Adaptive Intervention Approach for Children With Autism and Disruptive Behavior: A Pilot Study
1 other identifier
interventional
42
1 country
1
Brief Summary
Investigators seek to transform the delivery of health care to children with autism spectrum disorder (ASD) and behavioral health problems (and their families) by developing an innovative tiered set of interventions. Investigators aim to demonstrate that for children with ASD and disruptive behavior a family navigation-based intervention (autism behavioral health navigation; ABHN) will be feasible and more acceptable to families than brief social work consultation. For children with persistent disruptive behavior despite the social work or ABHN intervention Investigators will evaluate the feasibility and acceptability of adding consultation with an interprofessional team of ASD experts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
1 active site
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 16, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2021
CompletedMarch 11, 2022
March 1, 2022
1.7 years
December 16, 2019
March 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of children referred to the study each month meeting eligibility requirements
Prescribing clinicians from the following Divisions and Departments (DBP, Neurology, DCAPBS) will refer patients age 5-12 with ASD and disruptive behavior to the study. The number of children referred will be determined by counting the participants in the study who meet the inclusion criteria.
9 months
Secondary Outcomes (6)
Number of families successfully contacted by the navigator or social worker
9 months
Retention Rate
9 months
Number of subjects consented
9 months
Changes (or Improvement) with interpersonal relationships
9 months
Changes in ABC-irritability subscale
6 months
- +1 more secondary outcomes
Study Arms (2)
Social Worker vs Autism Behavioral Health Navigation (ABHN)
EXPERIMENTALPhase 1: Families providing informed consent will then be randomized to social work consultation or to the Autism Behavioral Health Navigation (ABHN) intervention. Non-responders to ABHN will move to ABHN + Complex Autism Program (CAP).
Social work + ABHN vs Social work + ABHN + CAP
EXPERIMENTALAt 3 months, children who are considered to be "responders" to their current treatment will continue; children who are "nonresponders" in the social work arm of the study will be randomized to either ABHN or ABHN+CAP. Children in the ABHN arm who are non-responders will receive ABHN + CAP
Interventions
The social worker will discuss the clinician's recommendations for needed services and how to access the services. The family will be provided the social worker's contact information and be encouraged to reach out with more questions or if more information is needed.
The goal of the ABHN intervention is to ensure access to recommended community behavioral health services, decrease parent stress levels, and/or improve child sleep and activity levels in order to reduce disruptive behaviors. Navigators will check-in at least weekly by telephone, email, or text message (as per family preference) during the first 4 weeks of the intervention and at least every 2 weeks for the remainder of the intervention or until ABHN and family agree that all goals and action steps in the Family Care Plan are completed.
After 3 months, children whose ABC Irritability Subscale scores improve by less than 5 points who received the social work intervention can be randomized to ABHN
After 3 months, children whose ABC Irritability Subscale scores improve by less than 5 points who received the social work intervention can be randomized to ABHN+Complex Autism Program (CAP)
Eligibility Criteria
You may qualify if:
- Child is age 5 through 12 years 11 months
- Diagnosed with autism spectrum disorder (ASD) and receives care for ASD at the Children's Hospital of Philadelphia (CHOP) in Developmental and Behavioral Pediatrics (DBP) or Child Neurology, or in Department of Child and Adolescent Psychiatry and Behavioral Sciences (DCAPBS)
- Child exhibits disruptive behaviors characterized by tantrums, outbursts, self-injurious, or aggressive behaviors with a Clinical Global Impression severity (CGI-S) for the disruptive behavior of at least 4
- A caregiver completed Aberrant Behavior Checklist (ABC-2) Irritability subscale score is greater than 13
- A parent of the child who is involved in coordinating the child's care will also participate as a research subject.
You may not qualify if:
- Child requires crisis intervention or urgent psychiatric consultation
- Referring physician or psychologist will not be providing ongoing management of the child's behavioral challenges.
- Parent needs a different intervention or type of assistance than will be available through the study
- Families who live outside a 40 mile radius from the Children's Hospital of Philadelphia (CHOP -main)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- Eagles Autism Challenge, Inccollaborator
- University of Pennsylvaniacollaborator
Study Sites (1)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (9)
Adams JS, Woods ER. Redesign of chronic illness care in children and adolescents: evidence for the chronic care model. Curr Opin Pediatr. 2016 Aug;28(4):428-33. doi: 10.1097/MOP.0000000000000368.
PMID: 27138998BACKGROUNDBearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.
PMID: 25898050BACKGROUNDChakraborty B, Murphy SA. Dynamic Treatment Regimes. Annu Rev Stat Appl. 2014;1:447-464. doi: 10.1146/annurev-statistics-022513-115553.
PMID: 25401119BACKGROUNDGuinchat V, Cravero C, Diaz L, Perisse D, Xavier J, Amiet C, Gourfinkel-An I, Bodeau N, Wachtel L, Cohen D, Consoli A. Acute behavioral crises in psychiatric inpatients with autism spectrum disorder (ASD): recognition of concomitant medical or non-ASD psychiatric conditions predicts enhanced improvement. Res Dev Disabil. 2015 Mar;38:242-55. doi: 10.1016/j.ridd.2014.12.020. Epub 2015 Jan 7.
PMID: 25575287BACKGROUNDJohnson CR, DeMand A, Lecavalier L, Smith T, Aman M, Foldes E, Scahill L. Psychometric properties of the children's sleep habits questionnaire in children with autism spectrum disorder. Sleep Med. 2016 Apr;20:5-11. doi: 10.1016/j.sleep.2015.12.005. Epub 2015 Dec 29.
PMID: 27318219BACKGROUNDLinn KA, Laber EB, Stefanski LA. iqLearn: Interactive Q-Learning in R. J Stat Softw. 2015 Feb;64(1):i01. doi: 10.18637/jss.v064.i01. Epub 2015 Mar 20.
PMID: 26900385BACKGROUNDShea S, Turgay A, Carroll A, Schulz M, Orlik H, Smith I, Dunbar F. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics. 2004 Nov;114(5):e634-41. doi: 10.1542/peds.2003-0264-F. Epub 2004 Oct 18.
PMID: 15492353BACKGROUNDLaurent PA. The emergence of saliency and novelty responses from Reinforcement Learning principles. Neural Netw. 2008 Dec;21(10):1493-9. doi: 10.1016/j.neunet.2008.09.004. Epub 2008 Sep 25.
PMID: 18938058BACKGROUNDVolker MA, Lopata C, Smerbeck AM, Knoll VA, Thomeer ML, Toomey JA, Rodgers JD. BASC-2 PRS profiles for students with high-functioning autism spectrum disorders. J Autism Dev Disord. 2010 Feb;40(2):188-99. doi: 10.1007/s10803-009-0849-6. Epub 2009 Aug 25.
PMID: 19705267BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan J Blum, M.D
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
Judith S Miller, Ph.D.
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Given the nature of the intervention families will not be blind to the intervention they are receiving. During phase 1 the investigator providing the clinical global impression (CGI) scores will be blind to the child's group assignment. Families will be asked not to discuss their work with a social worker or ABHN when completing interview questions at the interim assessments.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 18, 2019
Study Start
December 17, 2019
Primary Completion
August 27, 2021
Study Completion
August 27, 2021
Last Updated
March 11, 2022
Record last verified: 2022-03