Clinical trial NCT04204226: Autism and Disruptive Behavior Trial
Official title: Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Adaptive Intervention Approach for Children With Autism and Disruptive Behavior: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ASD
Child Behavior Problem
Keywords: Autism spectrum disorder
Sequential Multiple Assignment Randomized Trial
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eagles Autism Challenge, Inc
name: University of Pennsylvania
First posted: 2019-12-18
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Phase 1- Children with autism spectrum disorder (ASD) and disruptive behavior will be randomized to social work (SW) or autism behavioral health navigation (ABHN) Study Phase 2- Children who are responding to their Phase 1 intervention will remain in that intervention; children who are not responding to their Phase 1 intervention in the social work arm will be randomly assigned to either ABHN or ABHN+Complex Autism Program (CAP). Those not responding in the ABHN arm will receive ABHN + CAP.
Primary purpose: TREATMENT

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.

Detailed description: Context: It is often challenging to help families of children with autism spectrum disorder (ASD) manage disruptive behaviors. Family navigation and interprofessional care are promising care strategies that could be applied to care for these children.

Objectives: 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 persistent disruptive behavior despite the social work or ABHN intervention we will evaluate the feasibility and acceptability of adding consultation with an interprofessional team of ASD experts (Complex Autism Program; CAP).

Study Design: Investigators will conduct a Sequential Multiple Assignment Randomized Trial (SMART) of social work consultation, ABHN, and ABHN+CAP.

Setting/Participants:Participants will be children age 5-12 years, diagnosed with an ASD, receiving care for ASD at the Children's Hospital of Philadelphia (CHOP) in the Division of Developmental and Behavioral Pediatrics (DBP), Division of Neurology, or in the Department of Child and Adolescent Psychiatry and Behavioral Sciences (DCAPBS), and exhibiting high levels of disruptive behaviors (defined as an elevated score on the Aberrant Behavior Checklist (ABC) Irritability subscale and an elevated score on the Clinical Global Impression - Severity (CGI-S)). A parent of the child involved in coordinating the child's care will also be a participant in the study.

Study Interventions and Measures: Interventions include brief social work consultation, ABHN, and an interprofessional evaluation. The primary outcome measure will be the Aberrant Behavior Checklist (ABC) Irritability subscale. Secondary measures include the Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S and CGI-I), parent ratings of child behavior, parenting stress, and measures of feasibility and acceptability.

Eligibility criteria: Inclusion Criteria:

1. Child is age 5 through 12 years 11 months
2. 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)
3. 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
4. A caregiver completed Aberrant Behavior Checklist (ABC-2) Irritability subscale score is greater than 13
5. A parent of the child who is involved in coordinating the child's care will also participate as a research subject.

Exclusion Criteria:

1. Child requires crisis intervention or urgent psychiatric consultation
2. Referring physician or psychologist will not be providing ongoing management of the child's behavioral challenges.
3. Parent needs a different intervention or type of assistance than will be available through the study
4. Families who live outside a 40 mile radius from the Children's Hospital of Philadelphia (CHOP -main)

Primary outcomes:
measure: Number of children referred to the study each month meeting eligibility requirements
timeFrame: 9 months
Secondary outcomes:
measure: Number of families successfully contacted by the navigator or social worker
timeFrame: 9 months
measure: Retention Rate
timeFrame: 9 months
measure: Number of subjects consented
timeFrame: 9 months
measure: Changes (or Improvement) with interpersonal relationships
timeFrame: 9 months
measure: Changes in ABC-irritability subscale
timeFrame: 6 months
measure: Changes in levels of challenging behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Nathan J Blum, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Judith S Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bearss 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.
citation: Chakraborty B, Murphy SA. Dynamic Treatment Regimes. Annu Rev Stat Appl. 2014;1:447-464. doi: 10.1146/annurev-statistics-022513-115553.
citation: Guinchat 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.
citation: Johnson 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.
citation: Linn 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.
citation: Shea 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.
citation: Laurent 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.
citation: Volker 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.