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ASDNCT04204226

Autism and Disruptive Behavior Trial

A study testing Social Worker, Autism Behavioral Health Navigation (ABHN) and Social work + ABHN in people with ASD and Child Behavior Problem, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
ASD, Child Behavior Problem
What is being tested?
Social Worker, Autism Behavioral Health Navigation (ABHN) and Social work + ABHN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
17 Dec 2019to 27 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Social Worker, Autism Behavioral Health Navigation (ABHN), Social work + ABHN, Social work + ABHN + CAP
Keywords
Autism spectrum disorder, Sequential Multiple Assignment Randomized Trial
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social WorkerBehavioural

    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)Behavioural

    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 + ABHNBehavioural

    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 + CAPBehavioural

    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)

Study groups in NCT04204226
Study groupRoleWhat they receive
Social Worker vs Autism Behavioral Health Navigation (ABHN)ExperimentalPhase 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).
Receives: Behavioral: Social Worker; Behavioral: Autism Behavioral Health Navigation (ABHN)
Social work + ABHN vs Social work + ABHN + CAPExperimentalAt 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
Receives: Behavioral: Social work + ABHN; Behavioral: Social work + ABHN + CAP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 9 months

Secondary outcomes (6)

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

    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.

    Measured: 9 months

  2. Retention Rate

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

    Measured: 9 months

  3. Number of subjects consented

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

    Measured: 9 months

  4. Changes (or Improvement) with interpersonal relationships

    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

    Measured: 9 months

  5. Changes in ABC-irritability subscale

    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.

    Measured: 6 months

  6. Changes in levels of challenging behavior

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start17 Dec 2019
  3. Primary completion27 Aug 2021
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204226
Sponsor's protocol ID
19-016364
Status last verified
Mar 2022
First submitted
16 Dec 2019
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Adams JS, Woods ER. Redesign of chronic illness care in children and adolescents: evidence for the chronic care model. Curr Opin Pediatr. 2016 Aug;28(4):428-33. doi: 10.1097/MOP.0000000000000368.

    PubMed 27138998

  • Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150.

    PubMed 25898050

  • Chakraborty B, Murphy SA. Dynamic Treatment Regimes. Annu Rev Stat Appl. 2014;1:447-464. doi: 10.1146/annurev-statistics-022513-115553.

    PubMed 25401119

  • Guinchat V, Cravero C, Diaz L, Perisse D, Xavier J, Amiet C, Gourfinkel-An I, Bodeau N, Wachtel L, Cohen D, Consoli A. Acute behavioral crises in psychiatric inpatients with autism spectrum disorder (ASD): recognition of concomitant medical or non-ASD psychiatric conditions predicts enhanced improvement. Res Dev Disabil. 2015 Mar;38:242-55. doi: 10.1016/j.ridd.2014.12.020. Epub 2015 Jan 7.

    PubMed 25575287

  • Johnson CR, DeMand A, Lecavalier L, Smith T, Aman M, Foldes E, Scahill L. Psychometric properties of the children's sleep habits questionnaire in children with autism spectrum disorder. Sleep Med. 2016 Apr;20:5-11. doi: 10.1016/j.sleep.2015.12.005. Epub 2015 Dec 29.

    PubMed 27318219

  • Linn KA, Laber EB, Stefanski LA. iqLearn: Interactive Q-Learning in R. J Stat Softw. 2015 Feb;64(1):i01. doi: 10.18637/jss.v064.i01. Epub 2015 Mar 20.

    PubMed 26900385

  • Shea S, Turgay A, Carroll A, Schulz M, Orlik H, Smith I, Dunbar F. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics. 2004 Nov;114(5):e634-41. doi: 10.1542/peds.2003-0264-F. Epub 2004 Oct 18.

    PubMed 15492353

  • Laurent PA. The emergence of saliency and novelty responses from Reinforcement Learning principles. Neural Netw. 2008 Dec;21(10):1493-9. doi: 10.1016/j.neunet.2008.09.004. Epub 2008 Sep 25.

    PubMed 18938058

  • Volker MA, Lopata C, Smerbeck AM, Knoll VA, Thomeer ML, Toomey JA, Rodgers JD. BASC-2 PRS profiles for students with high-functioning autism spectrum disorders. J Autism Dev Disord. 2010 Feb;40(2):188-99. doi: 10.1007/s10803-009-0849-6. Epub 2009 Aug 25.

    PubMed 19705267

Questions about this trial

What is this clinical trial studying?

A study testing Social Worker, Autism Behavioral Health Navigation (ABHN) and Social work + ABHN in people with ASD and Child Behavior Problem, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of children referred to the study each month meeting eligibility requirements (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204226, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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