Autism and Disruptive Behavior Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2021-08-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ASD Child Behavior Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Social Worker vs Autism Behavioral Health Navigation (ABHN)

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).

Group Type EXPERIMENTAL

Social Worker

Intervention Type BEHAVIORAL

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.

Autism Behavioral Health Navigation (ABHN)

Intervention Type BEHAVIORAL

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.

Social work + ABHN vs Social work + ABHN + CAP

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

Group Type EXPERIMENTAL

Social work + ABHN

Intervention Type BEHAVIORAL

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

Social work + ABHN + CAP

Intervention Type BEHAVIORAL

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)

Interventions

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Social Worker

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.

Intervention Type BEHAVIORAL

Autism Behavioral Health Navigation (ABHN)

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.

Intervention Type BEHAVIORAL

Social work + 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

Intervention Type BEHAVIORAL

Social work + ABHN + CAP

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No