Autism and Disruptive Behavior Trial

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Child Behavior Problem; ASD

Treatments: Behavioral: Social work + ABHN; Behavioral: Autism Behavioral Health Navigation (ABHN); Behavioral: Social work + ABHN + CAP; Behavioral: Social Worker

Study type: Interventional

Funder types: Other

Identifiers

NCT04204226

19-016364

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

42 participants in 2 patient groups

Social Worker vs Autism Behavioral Health Navigation (ABHN)

Experimental group

Description:

Phase 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).

Treatment:

Behavioral: Social Worker

Behavioral: Autism Behavioral Health Navigation (ABHN)

Social work + ABHN vs Social work + ABHN + CAP

Experimental group

Description:

At 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

Treatment:

Behavioral: Social work + ABHN + CAP

Behavioral: Social work + ABHN