Written Language Intervention for Developmental Disabilities

Overseen By Alison Prahl, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor University

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a written language intervention can help young adults with intellectual and developmental disabilities improve their reading and writing skills. The treatment involves weekly sessions using everyday texts, delivered through telepractice (online sessions). Researchers will monitor participants over three months to assess improvements in functional literacy. Individuals with intellectual or developmental disabilities who can read most words, have practical literacy needs, and use English as their primary spoken language might be a good fit.

As an unphased trial, this study offers participants the chance to enhance their literacy skills through innovative online methods.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this written language intervention is safe for young adults with intellectual and developmental disabilities?

Research shows that programs like the one being studied, which help people improve their reading and writing, are generally safe. These programs don't use medicine or involve any physical procedures, so there are usually no medical side effects to consider.

In past studies, similar programs were well-received. Participants often noticed improvements in their language skills without negative effects. Since this treatment is educational and doesn't involve physical intervention, it is considered safe for participants. Those considering joining this type of trial can feel confident about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the written language intervention for developmental disabilities because it is delivered via telepractice, offering a more flexible and accessible option compared to traditional in-person therapies. Unlike standard treatments that often require physical attendance, this method allows participants to receive help from the comfort of their own homes, breaking down barriers related to location and mobility. Additionally, by focusing specifically on written language skills, this intervention targets an area that is frequently overshadowed by verbal communication therapies, potentially offering a more comprehensive approach to language development.

What evidence suggests that this written language intervention is effective for developmental disabilities?

Research has shown that writing programs can improve writing skills in people with intellectual and developmental disabilities. A review of studies found that these programs help children with these disabilities become better writers. Another analysis found that specific writing programs effectively aid students with learning disabilities. This trial will evaluate a written language intervention, providing participants with 3 months of weekly sessions via telepractice. Although limited data exists on young adults, practical writing exercises are believed to help them develop language skills, based on successes observed in other age groups. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young adults with intellectual and developmental disabilities who can see normally or with correction, read most words on a screener, need to improve their functional literacy, primarily speak English and communicate orally.

Inclusion Criteria

Have functional literacy needs

I primarily speak and communicate in English.

My vision is normal or corrected to normal with glasses or contacts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 months of weekly written language intervention sessions via telepractice

3 months

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessment at 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Written language intervention

Trial Overview The study is testing the effectiveness of a written language intervention that uses practical texts to help participants enhance their reading and writing skills in everyday situations.

How Is the Trial Designed?

Group I: Written language intervention Experimental Treatment 1 Intervention

Participants will receive 3 months of weekly written language intervention sessions via telepractice. Participants will be assessed at three time points to monitor outcomes.

Group II: Periodic language check-up Active Control 1 Intervention

Participants will be assessed at three time points to monitor outcomes.

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials

65

Recruited

67,600+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8005159/

Efficacy of the Treatment of Developmental Language Disorder However, no evidence emerged that this intervention actually improved outcome more than typical development. Finally, limitations also ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05851937?cond=Developmental%20Disabilities&lastUpdPost=2020-09-04_&viewType=Table&rank=10

Written Language Intervention for Adults With Intellectual ... The purpose of this study is to evaluate the effects of a written language intervention using functional texts for young adults with intellectual and ...

3. apps.asha.org apps.asha.org/EvidenceMaps/Articles/ArticleSummary/20187e85-086a-ee11-8147-005056834e2b

Summary of the Systematic Review This systematic review investigates the effects of intervention on writing skills for children with intellectual and developmental disabilities.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1747938X24000010

A meta-analysis of almost 40 Years of research The current meta-analysis aims at identifying the most effective interventions for students with Learning Disabilities (LD) in improving writing expression ...

5. ies.ed.gov ies.ed.gov/use-work/awards/development-and-efficacy-curriculum-based-language-and-early-literacy-intervention-preschool

The Development and Efficacy of a Curriculum-Based ... Language and early literacy outcomes will be measured at the beginning and end of each year. Data will be analyzed using mixed and multivariate ANOVA, growth ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12257067/

A Scoping Review of the Observed and Perceived Functional ... The study aims to describe and clarify the concepts of 'functional impact' and 'functional impairment,' as well as to identify and classify the leading ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1875957225001044

Effectiveness of early intervention and prediction ... The final analysis included 684 children (1368 MDAs). Of them, 58.9 % exhibited improved total developmental scores. Children who initially ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2722579

Timing and Intensity of Early Intervention Service Use and ... In this study, greater EI service intensity was associated with better functional gains, yet most children in the study received delayed care and/or low ...

9. pubs.asha.org pubs.asha.org/doi/10.1044/2023_LSHSS-22-00070

Abilities and Disabilities Among Children With ... Children with DLD present with predictable strengths and weaknesses in everyday language-related functioning.