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Completed

NCT Number: NCT04204226

Autism and Disruptive Behavior Trial

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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Key information

Conditions

ASD Autism Spectrum Disorder Child Behavior Problem Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Social Worker

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)

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

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

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)

Primary outcomes

  1. Number of children referred to the study each month meeting eligibility requirements

    Time frame: 9 months

    Prescribing clinicians from the following Divisions and Departments (DBP, Neurology, DCAPBS) will refer patients age 5-12 with ASD and disruptive behavior to the study. The number of children referred will be determined by counting the participants in the study who meet the inclusion criteria.

Secondary outcomes

  1. Number of families successfully contacted by the navigator or social worker

    Time frame: 9 months

    The number of families successfully contacted will be determined by reviewing contact logs of all contacts with the family and who initiated the contact; the duration of all contacts; the location of the contact; and the topic discussed, support provided, or toolkits reviewed.

  2. Retention Rate

    Time frame: 9 months

    The number of families retained will be determined by the number of families who complete treatment Phase 2

  3. Number of subjects consented

    Time frame: 9 months

    The number of families consented will be measured by the percentage of eligible families consenting to the study

  4. Changes (or Improvement) with interpersonal relationships

    Time frame: 9 months

    This is a nine-item measure designed to assess satisfaction with the interpersonal relationship with the navigator or SW. The measure has been shown to have high internal consistency and to be significantly correlated with overall satisfaction with care and not to be correlated with health literacy or patients' primary language

  5. Changes in ABC-irritability subscale

    Time frame: 6 months

    To meet eligibility the caregiver completed Aberrant Behavior Checklist-2 (ABC-2) Irritability subscale score needs to be > 13 (above the 50th percentile for children with ASD).This change will be measured by comparing the first stage interventions (SW vs. ABHN) and the change in ABC-irritability subscale score between baseline and the intermediate visit at month 3. At month 3, patients whose ABC Irritability subscale scores demonstrate improvement of at least 5 points (approximately ½ SD; moderate effect size) will remain in the same intervention. Patients whose ABC Irritability subscale scores suggest minimal to no improvement (less than 5 point improvement) will be randomized to either ABHN or ABHN+CAP if they were in the social work group in Phase 1 or will receive ABHN+CAP if they were in the ABHN arm of the study in phase 1. The primary efficacy endpoint for comparing the three embedded regimes will be ABC-irritability subscale at month 6.

  6. Changes in levels of challenging behavior

    Time frame: 6 months

    This will be measured by the Clinician Global Impression Scales (CGI). The CGI consists of a severity scale (CGI-S) and an Improvement scale (CGI-I). For the CGI-I, clinicians use record review to rate the level of change from the screening/baseline visit (1-3 indicating improvement, 4 indicating no change, 5-7 indicating a worsening of symptoms). The CGI-I will be completed at the 3- and 6-month follow up visits, and will measure the level of improvement compared to the CGI-S taken at screening/baseline.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eagles Autism Challenge, Inc
  • University of Pennsylvania

Registry information

Official study title

Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Adaptive Intervention Approach for Children With Autism and Disruptive Behavior: A Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 18, 2019
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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