NCT07137273

Brief Summary

This study is designed to better understand how certain features of reinforcement affect learning and motivation in individuals with intellectual and developmental disabilities (IDD). Participants will take part in a series of structured teaching sessions that involve simple tasks and reward-based feedback. By changing the timing and amount of rewards, we aim to learn how these factors influence the ability to acquire and maintain new skills. This information may help improve behavioral interventions for individuals with IDD in the future. The study does not involve medications or procedures intended to change participants' health status.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress87%
Oct 2024Aug 2026

Study Start

First participant enrolled

October 7, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

August 15, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

Operant ConditioningNeurodevelopmental disordersBehavioral interventions

Outcome Measures

Primary Outcomes (1)

  • Change in rate of behavior across schedules

    Number of target responses allocated emitted during experimental sessions in which reinforcement parameters (e.g., schedule arrangement, magnitude, and probability) are systematically varied. This measure will be derived from response data recorded during operant conditioning tasks. Changes in allocation patterns will be compared across schedule conditions to assess the effect of reinforcement manipulations.

    3 months

Study Arms (1)

Single-Arm: Manipulation of Reinforcement Schedules

EXPERIMENTAL

Participants will complete an operant conditioning task in which reinforcement schedules are systematically manipulated to evaluate changes in response patterns. All participants receive the same sequence of experimental conditions, which involve varying the availability and distribution of points exchangeable for preferred items or activities. No health-related treatment is provided; the procedures are designed to examine basic behavioral processes related to reinforcement dynamics.

Behavioral: Operant Conditioning Tasks with Reinforcement Manipulations

Interventions

This behavioral intervention involves structured operant conditioning tasks. Reinforcement parameters (e.g., schedule arrangement, magnitude, and probability) are systematically manipulated to evaluate their effects on behavioral allocation. The primary objective is to assess how variations in reinforcement contingencies influence choice patterns. The procedures are designed to examine fundamental behavioral processes rather than to provide therapeutic benefit.

Single-Arm: Manipulation of Reinforcement Schedules

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • At least 6 years of age
  • Documented neurodevelopmental condition
  • Engagement in problem behavior (e.g., aggression, self-injury, property destruction) that can be measured during study sessions
  • Ability to follow simple instructions
  • Ability to participate in tabletop choice-based tasks
  • Availability to complete all scheduled study sessions
  • Provision of informed consent by participant or legally authorized representative

You may not qualify if:

  • Severe sensory or motor impairments that would prevent participation in tabletop tasks
  • Current or recent participation (within the past 30 days) in another interventional behavioral research study that could interfere with study outcomes
  • Medical or behavioral conditions judged by investigators to pose a safety risk or interfere with data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Autism Research, Treatment, and Training

Auburn, Alabama, 36830, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

Oakland University

Rochester Hills, Michigan, 48309, United States

RECRUITING

MeSH Terms

Conditions

Intellectual DisabilityAutistic DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersAutism Spectrum DisorderChild Development Disorders, Pervasive

Study Officials

  • John M Falligant, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants receive the same sequence of experimental conditions. The design allows for within-subject comparisons across phases of the intervention to evaluate changes in operant responding under different schedule arrangements.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 22, 2025

Study Start

October 7, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

To protect participant privacy and confidentiality, only aggregate data and summary results will be disseminated through publications, presentations, and ClinicalTrials.gov.

Locations