Autism and Disruptive Behavior Trial

ASD Clinical 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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• ASD
• Child Behavior Problem
• Problem Behavior

• NCT number: NCT04204226
• Study type: Interventional
• Source: Children's Hospital of Philadelphia
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Completion date: August 27, 2021