Speech-Language Intervention for Language Disorder

No longer recruiting at 1 trial location

Overseen By Dionne Heller, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Autism, Hearing loss, Severe cognitive disability

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

Compensation: Varies

Number of Visits: 12

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal amount of speech-language therapy needed to enhance vocabulary in children with language impairments. It will compare two therapy schedules: one group will attend sessions once a week for 2 hours, while another group will attend four times a week for 30 minutes each. The goal is to assess whether fewer or more frequent sessions improve word learning, aiding experts in developing effective treatment plans. Children aged 5 to 8 with diagnosed language impairments and noticeable vocabulary issues may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for children to contribute to research that could influence future therapy practices.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this speech-language intervention is safe for children with language impairment?

Research shows that word learning activities are generally safe for children with language disorders. Studies have not found any safety issues with these activities, indicating that children handle them well. These activities aim to help children learn new words more easily, often through enjoyable methods like reading storybooks. Overall, current evidence supports the safety of these treatments for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Speech-Language Intervention for Language Disorder because it explores how different frequencies of therapy sessions might enhance word learning. Unlike traditional speech therapies that often have a set frequency and duration, this study examines both high-frequency (short, frequent sessions) and low-frequency (longer, less frequent sessions) interventions. This approach could reveal whether more frequent or more concentrated therapy sessions are more effective, potentially tailoring treatment plans to individual needs and improving outcomes for those with language disorders. By investigating these variations, researchers hope to uncover insights that may lead to more personalized and effective speech-language therapy strategies.

What evidence suggests that this word learning intervention is effective for language disorder?

Research has shown that certain teaching methods can help children with developmental language disorders (DLD) learn new words. For example, some studies suggest that specific techniques for practicing and testing word learning can be beneficial. One study found that although children with DLD may initially struggle to learn new words, they can eventually catch up to their peers with the right support. The success of these interventions often depends on their organization, particularly the frequency and duration of sessions. This trial will compare two different scheduling approaches: one group will receive high-frequency therapy sessions four times a week for 30 minutes each, while another group will receive low-frequency therapy sessions once a week for two hours each. The study aims to determine the most effective scheduling to help children improve their vocabulary. ^{1 6 7 8 9}

Who Is on the Research Team?

Mary Beth Schmitt, PhD

Principal Investigator

The University of Texas at Austin

Laura Justice, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for children aged 5 to nearly 7 with a primary diagnosis of language impairment, specifically in vocabulary. They must primarily speak English and score below the 10th percentile on certain vocabulary assessments. Children with autism, hearing loss, or severe cognitive disability are not eligible.

Inclusion Criteria

You have a condition that affects your ability to understand and use words.

You are between 5 and 6 years old.

Primarily communicates in English

Exclusion Criteria

Children with other conditions that could cause language difficulties, like autism or severe cognitive disability, will not be included.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive speech-language therapy either one time a week for 10 weeks (2 hours a session) or 4 times a week for 10 weeks (30 min per session) to improve vocabulary using word learning strategies.

10 weeks

10 or 40 sessions depending on assigned frequency

Follow-up

Participants are monitored for vocabulary gains and effectiveness of the intervention post-treatment.

6 months

Assessments at 2 weeks and 6 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Word Learning Intervention

Trial Overview The study aims to find the best amount of speech-language therapy for kids with language issues. It tests if attending therapy once a week for longer sessions or four times a week for shorter sessions leads to better vocabulary learning over ten weeks.

How Is the Trial Designed?

Group I: Low Frequency Experimental Treatment 1 Intervention

Participants will receive therapy 1 time a week for 10 weeks for 2 hours per session.

Group II: High Frequency Experimental Treatment 1 Intervention

Participants will receive therapy 4 times a week for 10 weeks for 30 minutes per session.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The study involved 20 children aged 6 to 8 with word-finding difficulties, and it found that targeted interventions focusing on semantic attributes significantly improved their word retrieval abilities compared to phonological interventions, with nearly double the gains.

The research highlights the importance of tailoring interventions based on individual language profiles, suggesting that personalized approaches could enhance the effectiveness of treatments for children with developmental language disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding differing outcomes from semantic and phonological interventions with children with word-finding difficulties: A group and case series study. Best, W., Hughes, L., Masterson, J., et al.[2022]

Phonological multimodal therapy significantly improved verbal naming abilities in a 52-year-old woman with a lexical phonological naming disorder, with results showing improvement for both trained and untrained words (p < 0.001).

The improvements in naming were maintained for at least 3 months post-therapy, and there was also a notable enhancement in daily communication (p < 0.05), indicating the therapy's effectiveness and potential for real-life application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal therapy of word retrieval disorder due to phonological encoding dysfunction. Weill-Chounlamountry, A., Capelle, N., Tessier, C., et al.[2019]

In a safety analysis of the CHIMES study involving 1,087 stroke patients, those treated with MLC601 experienced significantly fewer serious adverse events (SAEs) compared to those receiving a placebo, particularly for patients with multiple SAEs (6.7% vs. 29.3%).

Patients on MLC601 also had a significantly lower rate of prolonged hospitalizations, suggesting that MLC601 not only reduces SAEs but may also lessen the overall healthcare burden and associated medical costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study. Venketasubramanian, N., Moorakonda, RB., Lu, Q., et al.[2020]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

Children with developmental language disorder (DLD) struggle significantly with repeating nonwords of all lengths compared to typically developing (TD) peers, indicating a broader issue with phonological memory.

DLD children also face challenges in fast mapping, particularly with longer novel words, suggesting that their difficulties in encoding phonological information affect their ability to learn new words efficiently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast mapping short and long words: Examining the influence of phonological short-term memory and receptive vocabulary in children with developmental language disorder. Jackson, E., Leitao, S., Claessen, M., et al.[2020]

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

In a study of 123 children aged 2 to 5 with language problems, various treatment approaches were effective, with significant improvements in language skills observed across all groups after one year.

Targeted language therapy was crucial for improving language comprehension, as children who only received surgical hearing improvements did not show significant gains in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different treatments in young children with language problems. Keegstra, AL., Post, WJ., Goorhuis-Brouwer, SM.[2015]

Language therapy for patients with acquired aphasia has been shown to significantly improve their condition, but results vary widely due to different treatments and patient disorders.

Targeted treatments that focus on facilitating word retrieval using semantic or phonological cues can lead to lasting improvements, especially when tailored to the patient's existing abilities, suggesting a need for more personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of acquired aphasia. Howard, D.[2006]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

Citations

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

Efficacy of the Treatment of Developmental Language Disorder In approximately 40 to 50% of cases, linguistic impairments lead to negative neuropsychological sequelae [9], particularly at the time of the ...

2. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1517311/full

Vocabulary interventions for children with developmental ... Studies were appraised for quality and data was extracted relating to word-learning effectiveness and intervention characteristics. Findings ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2023_AJSLP-23-00037

A Word-Learning Intervention Pilot Study Utilizing ... A retrieval- and criterion-based approach is likely to support word learning during interventions for children with DLD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0749596X25000713

Word learning in children with developmental language ... The results indicated that the initial encoding of novel words was less effective in children with DLD, although both groups demonstrated similar abilities ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796000/

Effectiveness of intervention focused on vocational course ... In this study, we aimed to investigate the effectiveness of an intervention for young adults with language disorders aged 16–19 years, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9987562/

Speech-language disorder severity, academic success ... Extant research suggests that children with SLDs face an elevated risk for academic and socioemotional difficulties relative to their peers ...

7. pubs.asha.org pubs.asha.org/doi/10.1044/2024_LSHSS-24-00050

A Scoping Review of Intervention Outcomes for School ... The primary aim of this review was to identify the outcomes measured in intervention studies for school-aged children with speech, language, and communication ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06001866?term=learning%20AND%20language%20OR%20dyslexia%20OR%20dysgraphia&aggFilters=funderType:nih&viewType=Table&rank=3

Retrieval-Based Word Learning in Developmental ... The goal of the study is to increase children's absolute levels of verb learning while maintaining the advantage that repeated retrieval holds over comparison ...

9. withpower.com withpower.com/trial/phase-language-disorders-10-2023-3d270

Word Learning Intervention for Language Disorder The studies reviewed do not report any safety concerns related to word learning interventions, suggesting they are generally safe for human participants. Show ...