Speech-Language Intervention for Language Disorder

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

59 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the amount of speech-language intervention children with language impairment need to make vocabulary gains. The investigators hope to identify the optimal amount of intervention needed as well as the point at which adding more intervention is no longer beneficial. Participants will be randomly assigned (like a flip of a coin) to attend 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). Each therapy session will follow a word learning intervention that is designed to increase children's word learning abilities using rich, robust word learning strategies within story book readings. The optimal amount of intervention relates to duration, dose, and frequency. Duration refers to how long the child is seen for (e.g., 10 weeks, 1 year). Dose represents the number of exposures to each new vocabulary word within a therapy session. Frequency represents the number of therapy sessions per week. The investigators will test the hypothesis that distributed learning leads to higher gains. The investigators propose that the greatest gains will be observed for children who receive high-frequency/low-dose or low-frequency/high-dose treatments as compared to children who receive high-frequency/high-dose or low-frequency/low-dose treatments. The investigators will test the hypothesis that for both low-frequency and high-frequency treatments, there is a point at which increases in treatment dose do not correspond to any additional gains in children's vocabulary skills during treatment. At the close of this four-year study, evidence concerning optimal treatment intensity of a word learning intervention will be instrumental for immediately informing speech-language pathologists in how much vocabulary treatment to prescribe as well as for designing additional clinical trials by our and other research teams.

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 data supports the effectiveness of the treatment Word Learning Intervention for Language Disorder?

Research shows that interventions focusing on word-finding strategies, such as semantic and phonological approaches, can significantly improve word retrieval in children with language disorders. These treatments have been shown to enhance word-finding abilities, suggesting that similar methods could be effective in the Word Learning Intervention. ^{1 2 3 4 5}

Is the Speech-Language Intervention for Language Disorder generally safe for humans?

Research on psychological interventions, including those for language disorders, often lacks comprehensive reporting on safety. However, studies suggest that serious adverse events are rare and not typically related to the intervention itself, indicating a generally safe profile. ^{6 7 8 9 10}

How does the Word Learning Intervention treatment differ from other treatments for language disorder?

The Word Learning Intervention is unique because it uses retrieval- and criterion-based learning strategies, which are designed to improve both the learning and retention of words in children with developmental language disorder. This approach focuses on actively recalling words and meeting specific learning criteria, which may enhance learning efficiency compared to other methods. ^{3 11 12 13 14}

Research Team

Mary Beth Schmitt, PhD

Principal Investigator

The University of Texas at Austin

Laura Justice, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Multimodal therapy of word retrieval disorder due to phonological encoding dysfunction. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effect of different treatments in young children with language problems. [2015]

3. Italy 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Teaching word-finding strategies to severely language-impaired children. [2006]

5. England pubmed.ncbi.nlm.nih.gov

The treatment of acquired aphasia. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

10. Switzerland 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. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

The Challenge of Rich Vocabulary Instruction for Children With Developmental Language Disorder. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A Word-Learning Intervention Pilot Study Utilizing Principles of Retrieval- and Criterion-Based Learning for Children With Developmental Language Disorder. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Word learning by preschoolers with specific language impairment: predictors and poor learners. [2022]

14. United States 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. [2020]