NCT05918393

Brief Summary

This project examines mechanisms to address two significant challenges present in communication-based behavioral interventions for individuals with autism and comorbid severe destructive behavior (SDB): (a) inflexible communication responding and (b) reemergence of severe destructive behavior when challenges to treatment integrity occur. Achieving the proposed aims will advance clinical practice related to the treatment of SDB and generalization of treatment effects to mitigate against the resurgence of SDB

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

June 2, 2023

Results QC Date

August 25, 2023

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Averge of Aappropriate Communication Responses

    Appropriate communication responses for each participant will be selected based on language level as identified via the Peabody Picture Vocabulary Test, 4th edition (PPVT-4) and/or the Expressive Vocabulary Test-3rd edition (EVT-3)

    Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.

  • Average of Problem Behavior Responses

    Individualized operational definitions of problem behavior and communication were developed for each participant. These included aggression, disruption, self-injurious behavior. Communication included card exchanges, manual signs, card touches, and augmentative device responding. These behaviors were measured via direct observation and data were analyzed by visual inspection.

    Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.

Study Arms (1)

Functional communication training (FCT)

OTHER

During FCT, signaled intervals of reinforcement (i.e., the functional reinforcer is available contingent on communication) and extinction (i.e., the functional reinforcer is unavailable and thus both severe destructive behavior (SDB) and communication are on extinction) will be alternated within a single session. During the treatment-challenge evaluation, SDB will remain on extinction throughout and all communication responses will be reinforced on an FR-1 schedule during the signaled reinforcement intervals.

Behavioral: functional communication training

Interventions

During functional communication training, signaled intervals of reinforcement (i.e., the functional reinforcer is available contingent on communication) and extinction (i.e., the functional reinforcer is unavailable and thus both problem behavior and communication are on extinction) will be alternated within a single session. All communication responses will be reinforced every time they occur during the signaled reinforcement intervals.

Also known as: differential reinforcement
Functional communication training (FCT)

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • between 5 and 13 years of age
  • documented diagnosis of autism spectrum disorder (ASD) or a diagnosis confirmed based on the relevant cutoff score of the Autism Diagnostic Observation Scale (ADOS-2)
  • referred for clinical assessment and treatment of severe destructive behavior (SDB; e.g., SIB, aggression) that (a) poses a serious danger to self, others, or the environment, and (b) interferes with the child receiving an appropriate education
  • children whose functional analysis results indicate that SDB is maintained by social-negative or social-positive reinforcement will be admitted to this investigation.

You may not qualify if:

  • severity of their SDB prohibits exposure to baseline conditions
  • undergoing changes in their medication regimen
  • results of the functional analyses indicate that their SDB is maintained by automatic reinforcement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Limitations and Caveats

Limitations included enrollment of less than 50% of the anticipated sample. Results should be interpreted with caution given the low sample size.

Results Point of Contact

Title
Dr. Henry Roane
Organization
SUNY Upstate Medical University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-case research design including multielement and reversal strategies
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 26, 2023

Study Start

April 22, 2019

Primary Completion

August 20, 2021

Study Completion

December 7, 2021

Last Updated

March 5, 2026

Results First Posted

March 5, 2026

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations