NCT06651606

Brief Summary

The goal of this clinical trial is to compare a novel tactic for mitigating reinstatement compared to the current standard of care approach using a translational-treatment model. The main questions it aims to answer are:

  1. 1.how well does progressive ratio training mitigate response-dependent reinstatement compared to the standard of care approach?
  2. 2.how well does progressive ratio training mitigate response-independent reinstatement compared to the standard of care approach?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 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 Progress82%
Sep 2024Sep 2026

Study Start

First participant enrolled

September 30, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Expected
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

October 18, 2024

Last Update Submit

August 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Treatment Effectiveness

    The number of individuals for whom treatment remains effective (either progressive ratio training or current standard-of-care), which investigators will determine by comparing the mean rate of responding in baseline and subsequent conditions (Treatment and Reinstatement Tests 1 and 2). If investigators find at least an 80% reduction in target behavior in a condition (a standard clinical target for problem behavior), they will conclude that the treatment is effective (or remains effective).

    2 years

Secondary Outcomes (1)

  • Proportional and Comparative Effectiveness

    2 years

Study Arms (2)

Progressive Ratio Training

EXPERIMENTAL

Participants in the progressive ratio training Arm will experience the novel reinstatement-mitigation tactic: Progressive Ratio Training (PRT). Progressive ratio training (PRT) is used to prevent recurrence of the proxy response when extinction errors occur. PRT involves providing a reinforcer for the proxy response on a geometric progressive ratio (PR) scale. The schedule requirement will increase for the target response each time a reinforcer is delivered. For example, once a reinforcer is delivered on the PR-2 schedule, the requirement will increase to a PR-4, then to a PR-8, -16, -32, etc.

Behavioral: Progressive Ratio Training (PRT)

Standard of Care

EXPERIMENTAL

Participants in the standard of care Arm will receive an analogue to the standard of care approach for problem behavior: differential reinforcement of alternative behavior (DRA) with extinction. In DRA with extinction, the proxy for problem behavior will cease to produce reinforcement while the proxy for communication behavior will produce reinforcement on a fixed-ratio 1 schedule of reinforcement.

Behavioral: Differential Reinforcement of Alternative (DRA) Behavior with Extinction

Interventions

Progressive ratio training (PRT) is used to prevent recurrence of the proxy response when extinction errors occur. PRT involves providing a reinforcer for the proxy response on a geometric progressive ratio (PR) scale. The schedule requirement will increase for the target response each time a reinforcer is delivered. For example, once a reinforcer is delivered on the PR-2 schedule, the requirement will increase to a PR-4, then to a PR-8, -16, -32, etc.

Progressive Ratio Training

In DRA with extinction, the proxy for problem behavior is placed on extinction and no longer produces reinforcement. The proxy for communication behavior produces reinforcement on a fixed-ratio 1 schedule of reinforcement.

Standard of Care

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Boys and girls from ages 6 to 21
  • Engage in problem behavior
  • Diagnosis of some type of intellectual and developmental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

Oakland University

Rochester, Michigan, 48309, United States

RECRUITING

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Study Officials

  • Michael P Kranak, PhD

    Oakland University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael P Kranak, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 22, 2024

Study Start

September 30, 2024

Primary Completion

March 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The investigators plan to share outcome data as specified in the approved Data Management and Sharing Plan.

Time Frame
Data will become available at the completion of the study as specified in the approved Data Management and Sharing Plan.
Access Criteria
Data will be accessible as specified in the approved Data Management and Sharing Plan.

Locations