Autism and Disruptive Behavior Trial
Condition: ASD; Child Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

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.
    

Intervention name(s): Social Worker; Autism Behavioral Health Navigation (ABHN); Social work + ABHN; Social work + ABHN + CAP
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Autism spectrum disorder; Sequential Multiple Assignment Randomized Trial