60 Participants Needed

Communication Strategies for Intellectual Disability

Recruiting at 1 trial location
JR
Overseen ByJoel Ringdahl, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Joel E. Ringdahl
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different communication tools can reduce challenging behaviors in people with intellectual or developmental disabilities. The researchers aim to determine if using a preferred communication method, such as a touch talker or picture cards, maintains positive behavior changes more effectively than a less preferred method. Participants will first use their preferred communication tool, then switch to another tool, to assess which is more effective in sustaining new behaviors when the intervention is interrupted. This trial suits those diagnosed with intellectual or developmental disabilities who have been referred for help with challenging behaviors. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance communication strategies for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these communication strategies are safe for individuals with intellectual and/or developmental disabilities?

Research has shown that the two communication strategies tested in this trial—PrefFCT and NonPrefFCT—are generally safe. These strategies aim to improve communication and reduce challenging behavior in people with intellectual and developmental disabilities (I/DD).

For NonPrefFCT, which uses a less preferred communication method, specific safety data is unavailable. However, the trial's "Not Applicable" phase suggests minimal safety concerns, as this phase typically involves methods not expected to cause harm.

Similarly, PrefFCT, which uses a more preferred communication method, is also considered safe. Although direct safety data is limited, studies indicate that people with I/DD may have higher health risks in general. However, these risks are not directly related to the communication strategies tested.

Overall, both PrefFCT and NonPrefFCT focus on communication and behavior, not medication, so they are expected to be well-tolerated and safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for Communication Strategies for Intellectual Disability because it explores new ways to reinforce communicative responses in individuals with intellectual disabilities. Unlike traditional methods that may not differentiate based on personal preference, this trial investigates both preferred (PrefFCT) and non-preferred (NonPrefFCT) communication modalities. By tailoring reinforcement to the individual's preferred communication style, the trial aims to improve engagement and effectiveness, potentially paving the way for more personalized and successful communication interventions.

What evidence suggests that this trial's communication strategies could be effective for reducing challenging behavior in individuals with intellectual disabilities?

This trial will compare two communication strategies: PrefFCT and NonPrefFCT. Research has shown that using preferred communication methods, like those in the PrefFCT arm, can reduce difficult behaviors in individuals with intellectual disabilities. Studies have found that when individuals use their favorite ways to communicate, they tend to continue using them regularly, even without reminders. For instance, one study discovered that people often stick to their preferred messaging style, which helps maintain behavior changes. Conversely, methods they like less, similar to those in the NonPrefFCT arm, might not be as effective for long-term changes. This suggests that focusing on preferred communication styles could be important for lasting improvements in communication and behavior.678910

Are You a Good Fit for This Trial?

This trial is for individuals with intellectual and/or developmental disabilities, including those with speech impairment, autism spectrum disorder, or communication disorders. Participants should exhibit challenging behavior that may be reduced through effective communication strategies.

Inclusion Criteria

Diagnosis of intellectual or developmental disability
Referred for assessment and treatment of challenging behavior
I am at least 2 years old.

Exclusion Criteria

I can talk and make myself understood.
Challenging behavior does not occur within the context of structured assessment, eliminating the ability to identify its operant function, or the behavior is deemed too dangerous to safely observe during assessment
Can only identify one proficient AAC strategy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Experimental Phase

Participants complete assessments to establish communication modalities and preferences

4 weeks

Randomization and Initial Intervention

Participants are randomized to either preferred or non-preferred communication strategy and undergo initial intervention

6 weeks
Weekly visits (in-person)

Crossover Intervention

Participants switch to the alternative communication strategy and undergo a second round of intervention

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for persistence of communication and relapse of challenging behavior

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NonPrefFCT
  • PrefFCT

Trial Overview

The study compares the effectiveness of preferred versus non-preferred communication strategies (like touch talkers vs. picture cards) in maintaining treatment when regular intervention is disrupted. It also examines if preference affects relapse and how demographic factors like age and symptom severity influence outcomes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: PrefFCTExperimental Treatment1 Intervention
Group II: NonPrefFCTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joel E. Ringdahl

Lead Sponsor

University of Florida

Collaborator

Trials
1,428
Recruited
987,000+

Virginia Polytechnic Institute and State University

Collaborator

Trials
162
Recruited
26,900+

University of Iowa

Collaborator

Trials
486
Recruited
934,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Communication Support Needs in Adults with Intellectual ...

[4] identified communication skills in a sample of 601 adults with ID, finding that 57.9% experienced communication difficulties and, in 23.5% ...

Communication difficulties in adults with Intellectual Disability

Outcomes and results. Overall, 57.9 % of participants experienced communication difficulties, with 23.5 % reporting severe difficulties. Only 75.1 % of ...

NCT07278544 | Harnessing Communication Preferences

During NonPrefFCT, participants will receive access to the functionally relevant reinforcer following occurrences of the specified ...

Preferred Communication Strategies for People with ...

We aimed to describe communication strategies that patients with CDs find most useful and optimize a tool for patients to share their communication strategy ...

Improving Communication Strategies for Adults with an ...

Assertive communication is the most effective way to communicate for those individuals with and without an intellectual disability (Brady, Bruce, et al, 2016).

National Core Indicators®-IDD

The core indicators are standard measures used across states to assess the outcomes of services provided to individuals and families. Indicators address key ...

I/DD Counts

I/DD Counts aims to be that reliable resource tool to improve the nation's health surveillance system for people with I/DD.

Advancing Health Policy and Outcomes for People With ...

Recruiting the voices of persons with intellectual and developmental disabilities in policy development: Priorities for health equity data.

Assessing Outcomes Relevant for Patient-Centered ...

We identified six broad outcome domains relevant to PCOR for adults with disabilities from prior research, including: (1) social and community ...

Quality monitoring of intellectual and developmental ...

NCI® data make it possible for participating states to track changes in performance, compare outcomes across states, and monitor national trends ...