Expanding Interventions for Automatically Maintained SIB

NCT06739616 | Completed

• 1 other identifier: 00006603
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to demonstrate feasibility of procedures and compare the outcomes of intervention arrangements to reduce sensory based self-injurious behavior exhibited by individuals with intellectual and developmental disabilities. The main question\[s\] it aims to answer are: (1) Demonstrate ability to meet enrollment requirements. (2) Evaluate acceptability and feasibility of participation relative to observation length and study duration. (3) Track and compare participant progress across interventions. (4) Demonstrate acceptable procedural fidelity and interobserver agreement. And (5) conduct post hoc evaluation of clinical presentation and intervention match. Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Conditions

Self-Injurious Behavior; Problem Behavior; Intellectual Disability; Autism Spectrum Disorder; Restricted Behavior

Outcome Measures

Primary Outcomes (1)

• Rate of Self-Injurious Behavior exhibited by individual participants as measured by direct observation

  Behavior that causes or has potential to cause injury to the participant

  Change in level of SIB from pre-intervention to intervention

Study Arms (2)

Study 1: Longevity

EXPERIMENTAL

Study 1: Longevity will evaluate the impact of matched and unmatched competing stimuli on reinforcement-based interventions as implementation durations are increased. Three conditions will be compared, using within-subjects single case designs: (a) baseline (no intervention), (b) intervention with competing stimuli matched to the hypothesized sensory consequences of SIB, and (c) intervention with competing stimuli unmatched to the hypothesized sensory consequences of SIB. Participants' specific intervention will be either noncontingent reinforcement (NCR) or differential reinforcement of other behavior (DRO), based on the outcomes of the pre-intervention assessments. During NCR, participants will receive access to competing stimuli on an ongoing and response-independent basis. During DRO, participants will receive access to competing stimuli contingent on the omission of SIB for a pre-determined length of time. Implementation will gradually increase up to a maximum of three hours.

Behavioral: AUTOSIB across time

Study 2: Schedule Thinning

EXPERIMENTAL

Study 2: Schedule Thinning will evaluate the impact of matched and unmatched competing stimuli on reinforcement-based interventions as access to reinforcers decreases. Three conditions will be compared, using within-subjects single case designs: (a) baseline (no intervention), (b) intervention with competing stimuli matched to the hypothesized sensory consequences of SIB, and (c) intervention with competing stimuli unmatched to the hypothesized sensory consequences of SIB. Participants' specific intervention will be either noncontingent reinforcement (NCR) or differential reinforcement of other behavior (DRO), based on the outcomes of the pre-intervention assessments. During NCR, participants will receive access to competing stimuli on an ongoing and response-independent basis. During DRO, participants will receive access to competing stimuli contingent on the omission of SIB for a pre-determined length of time. Access to reinforcers will decrease across successful implementations.

Behavioral: AUTOSIB diminished reinforcement

Interventions

AUTOSIB across time BEHAVIORAL

Intervention will be in place across increasing time frames.

Study 1: Longevity

AUTOSIB diminished reinforcement BEHAVIORAL

Intervention will be in place with decreasing levels of reinforcement

Study 2: Schedule Thinning

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Diagnosis of intellectual and/or developmental disability
• Referred for assessment and treatment of self-injurious behavior
• Behavior maintained by automatic reinforcement function

You may not qualify if:

• Behavior maintained by a social reinforcement (e.g., attention, escape) function

Sponsors & Collaborators

• University of Georgia: lead
• May Institute: collaborator

Study Sites (1)

May Institute

Randolph, Massachusetts, 02368, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Problem Behavior; Intellectual Disability; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Joel E Ringdahl, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single case research design

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: December 18, 2024
• Study Start: April 18, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Descriptive/raw data on subject characteristics are expected to be submitted to NDAR on a semi-annual basis (on or before January 15 and July 15). Outcome data are uploaded at the time of first publication. Data are made publicly available within four months of submission. To ensure timely submission of outcome data, the investigators will monitor data quality on an ongoing basis so that they can lock the dataset within six months after the investigators complete data collection. A report will be submitted of the primary findings for publication in a peer-refereed journal within one year after completed data collection. Because the data will reside at NDAR, they will remain available indefinitely, regardless of whether the investigators remain at their current institutions.
• Access Criteria: No specified criteria.

Locations

US (1)