Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autism and Disruptive Behavior Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04204226
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : January 13, 2021
Sponsor:
Collaborators:
Eagles Autism Challenge, Inc
University of Pennsylvania
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief 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.

Condition or disease Intervention/treatment Phase
ASD Child Behavior Problem Behavioral: Social Worker Behavioral: Autism Behavioral Health Navigation (ABHN) Behavioral: Social work + ABHN Behavioral: Social work + ABHN + CAP Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Assessing the Feasibility, Acceptability, and Preliminary Efficacy of an Adaptive Intervention Approach for Children With Autism and Disruptive Behavior: A Pilot Study
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: 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).

Behavioral: 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.

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.

Experimental: 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
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

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204226


Contacts
Layout table for location contacts
Contact: Manju M Abraham, M.S (215) 970-6584 Abrahammm@email.chop.edu

Locations
Layout table for location information
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Manju Abraham, M.S    215-970-6584    Abrahammm@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Eagles Autism Challenge, Inc
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Nathan J Blum, M.D Children's Hospital of Philadelphia
Principal Investigator: Judith S Miller, Ph.D. Children's Hospital of Philadelphia
Publications:

Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04204226    
Other Study ID Numbers: 19-016364
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Autism spectrum disorder
Sequential Multiple Assignment Randomized Trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Problem Behavior
Behavioral Symptoms