Language Intervention for Developmental Language Disorder

Overseen By Paula Nino Kher

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Disqualifiers: Sensory-motor concerns, Psychiatric disorders

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

Compensation: Varies

Number of Visits: 32

Duration: 9 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help bilingual children with Developmental Language Disorder (DLD) improve their language skills. It tests various language therapy methods, including sessions in Spanish, English, or a combination of both. The goal is to determine which method most effectively boosts language abilities and supports long-term academic success. Children who typically use simple sentences in both Spanish and English and face ongoing language challenges may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for children to explore personalized language therapy methods that could enhance their communication skills and academic achievements.

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 language intervention is safe for children with Developmental Language Disorder?

Research shows that sentence recast therapy is well-tolerated and improves language skills in children with Developmental Language Disorder (DLD). Studies have found that this method helps children learn grammar faster and more effectively through conversations.

This therapy comes in three versions: Spanish-only, English-only, and bilingual (switching between Spanish and English). In each version, a trained speech-language pathologist (SLP) guides children through conversational exercises. Evidence from past studies suggests these treatments are safe and focus on language development without any reported negative effects.

The therapy does not involve medication, which usually means fewer side effects. Instead, it uses a natural approach, making it a safe choice for children. Although specific safety details aren't provided in the sources, the focus on language improvement and the conversational style of the therapy support its good tolerance among participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the language intervention for developmental language disorder because it explores different methods of sentence recasting, which is a technique that involves repeating a child's incorrect sentence back to them in a corrected form. Unlike traditional language therapies that may not systematically vary the language of instruction, this trial investigates both monolingual and bilingual approaches. The bilingual arm is particularly innovative, alternating between English and Spanish to ensure balanced language exposure, which could be groundbreaking for children who are bilingual. By tailoring the therapy to either a single language or both, the study aims to reveal how language-specific or dual-language interventions can best support children with developmental language disorder, potentially offering more personalized and effective treatment options.

What evidence suggests that this trial's treatments could be effective for Developmental Language Disorder?

Research has shown that conversational recast treatment effectively teaches grammar to children with language disorders, such as Developmental Language Disorder (DLD). In this trial, participants will receive sentence recast therapy in various language settings. One group will receive sentence recasts in Spanish-only, which studies have found to be effective for bilingual children. Another group will receive bilingual Spanish-English recasts, also shown to be effective. A third group will receive sentence recasts in English-only, with evidence supporting its effectiveness in improving grammar. Overall, sentence recast therapy, whether in Spanish, English, or both, has been shown to boost language skills in children with DLD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for bilingual children in the USA with Developmental Language Disorder (DLD), who have concerns from parents or history of public school services, an IQ score above 70, pass a hearing test, and can produce simple sentences in both English and Spanish. Children with significant sensory-motor issues or psychiatric disorders are excluded.

Inclusion Criteria

I meet the required language skills in English or Spanish for my age.

You must pass a hearing test.

Participants need to have difficulty with using and understanding language in both English and another language.

Exclusion Criteria

Children with significant sensory-motor concerns or psychiatric disorders per parent report will not be enrolled

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three possible treatments (English-only, Spanish-only, bilingual) for one grammatical structure for 9 weeks

9 weeks

16 hours of therapy spread over 9 weeks

Second Treatment

The second grammatical structure is treated for 9 weeks, and outcomes are assessed a third time

9 weeks

16 hours of therapy spread over 9 weeks

Follow-up

Participants are monitored for language outcomes and cross-linguistic transfer effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sentence recast

Trial Overview The study tests whether language proficiency affects outcomes when treating bilingual children with DLD using sentence recast therapy. It compares monolingual intervention in English or Spanish to bilingual intervention alternating between languages to improve academic success.

How Is the Trial Designed?

Group I: sentence recast in Spanish only Experimental Treatment 1 Intervention

A trained, bilingual SLP will treat the targeted structure at a rate of \~ 1 recast per minute, for 16 hours spread over 9 weeks to obtain a planned dose of 912-1008 recasts (960 +/- 5%). Following evidence on enhanced conversational recasting, the SLP will obtain the child's attention before recasting and systematically vary the lexical items in the recasts. Children receiving monolingual Spanish therapy will have the entire treatment session conducted in Spanish.

Group II: sentence recast in English only Experimental Treatment 1 Intervention

A trained, bilingual SLP will treat the targeted structure at a rate of \~ 1 recast per minute, for 16 hours spread over 9 weeks to obtain a planned dose of 912-1008 recasts (960 +/- 5%). Following evidence on enhanced conversational recasting , the SLP will obtain the child's attention before recasting and systematically vary the lexical items in the recasts. Children receiving monolingual English therapy will have the entire treatment session conducted in English.

Group III: sentence recast - Bilingual (Spanish+English) intervention Experimental Treatment 1 Intervention

Treatment will differ from monolingual therapy in that the child will be seen by two SLPs in keeping with one-person one-language models. This allows us to ensure that the dose in each language is controlled and supports the use of both languages evenly in therapy. Sessions will alternate between English-only therapy and Spanish-only therapy - thus the child will receive 8 hours of therapy treating the selected target in English and 8 hours treating the selected target in Spanish. A child in bilingual therapy will receive approximately 456-504 (480 +/- 5%) recasts in each language for a total of 912-1008 recasts combined.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

In a study involving 21 children with specific language impairment, both imitative and conversational recast interventions were effective in teaching grammatical morphemes and complex sentences, but conversational methods required fewer repetitions for children to use language spontaneously.

Conversational-interactive interventions not only led to quicker transitions from prompted to spontaneous speech but also resulted in a greater number of spontaneous language productions compared to imitative interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of conversational-recasting and imitative procedures for training grammatical structures in children with specific language impairment. Camarata, SM., Nelson, KE., Camarata, MN.[2019]

Oral immunotherapy (OIT) for food allergies carries a risk of adverse reactions, including anaphylaxis, which is a significant barrier to its clinical use.

There is a need for an international consensus on safety reporting in OIT studies to better understand its safety profile and develop safer, individualized treatment pathways for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Food Oral Immunotherapy: What We Know, and What We Need to Learn. Vázquez-Cortés, S., Jaqueti, P., Arasi, S., et al.[2020]

Children with developmental language disorder who take longer than 10 days to correctly answer treatment items are unlikely to benefit from Enhanced Conversational Recast therapy, indicating a need for timely assessment of treatment effectiveness.

The study found that generalization of language skills after treatment is closely linked to accuracy achieved during treatment, but achieving less than 100% accuracy during therapy does not guarantee future generalization, suggesting that clinicians should aim for consistent high accuracy before concluding treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Informed Guideposts for Decision Making in Enhanced Conversational Recast Treatment. Hall, J., Plante, E.[2022]

Immunotherapy has been shown to be effective in treating children with allergic rhinitis and asthma, potentially reducing the risk of developing additional allergies and asthma itself, based on a review of studies from 1967 to 2005.

However, there are safety concerns, particularly for children with asthma, as severe reactions can occur, especially during the initial treatment phases or if administered without proper supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of allergen immunotherapy in children. Nelson, HS.[2019]

In a study involving 47 preschool children with developmental language disorder, spontaneous repetition of clinician-modeled morphemes was found to significantly correlate with improved production of those morphemes during treatment.

Children who frequently and correctly repeated targeted morphemes not only showed better performance in using those forms but also had larger treatment effect sizes, suggesting that these repetitions may help them learn and master language structures more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Spontaneous Repetitions During Treatment of Morphosyntactic Forms for Children With Developmental Language Disorder. Nicholas, K., Plante, E., Gómez, R., et al.[2023]

The study involved 16 children aged 4 to 5 years with specific language impairment (SLI) who underwent a 5-week intervention targeting grammatical morphology, showing significant improvement in morpheme usage regardless of the treatment schedule.

Both massed (one 30-min session) and spaced (three 10-min sessions) treatment conditions were effective, indicating that clinicians can choose flexible dosing schedules without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose Schedule and Enhanced Conversational Recast Treatment for Children With Specific Language Impairment. Meyers-Denman, CN., Plante, E.[2018]

In a review of 27 studies involving 1488 children undergoing peanut oral immunotherapy (POIT), adverse events were common, leading to treatment discontinuation in 6.6% of participants and requiring epinephrine in 7.6%.

Modifications to treatment protocols, such as avoiding rush treatment phases and using co-treatments, may reduce the risk of adverse events and improve overall treatment outcomes for children with peanut allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with peanut oral immunotherapy in children - a systematic review and meta-analysis. Grzeskowiak, LE., Tao, B., Knight, E., et al.[2021]

Conversational recast treatment was found to be more effective than imitative treatment for helping both children with specific language impairment (SLI) and those with normal language skills acquire new language targets more quickly.

Children with SLI can learn grammatical structures as efficiently as their language-normal peers when given tailored language input that matches their developmental levels, suggesting that effective treatment strategies can bridge the gap in language acquisition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of imitative and conversational recasting treatment on the acquisition of grammar in children with specific language impairment and younger language-normal children. Nelson, KE., Camarata, SM., Welsh, J., et al.[2019]

Enhanced conversational recast treatment effectively improved the correct usage of targeted morphemes in preschoolers with developmental language disorder, regardless of whether they received treatment individually or in a small group setting (n = 20).

However, children in the group condition did not show significant improvement in using their partner's target morpheme, suggesting that simply hearing the target modeled is not enough for learning; active engagement with the recast is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Versus Small Group Treatment of Morphological Errors for Children With Developmental Language Disorder. Eidsvåg, SS., Plante, E., Oglivie, T., et al.[2023]

In a study involving 92 preschoolers undergoing tree nut oral immunotherapy (TN-OIT), 96.7% successfully reached the maintenance dose, indicating high efficacy and tolerability of the treatment.

The majority of participants (70.7%) experienced mild reactions during the buildup phase, with only 2.17% requiring epinephrine, suggesting that TN-OIT is generally safe for preschoolers, similar to previous findings with peanut OIT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety Analysis of Preschool Tree Nut Oral Immunotherapy. Erdle, SC., Cook, VE., Cameron, SB., et al.[2023]

Integrating speech and grammatical interventions using recast treatment showed positive effects on speech-comprehensibility in 4 out of 6 children with Down syndrome, indicating a potential benefit of this combined approach.

Five out of 6 participants demonstrated growth in mean length of utterance (MLU) during generalization sessions, suggesting that this method may effectively enhance both speech clarity and grammatical skills in children with Down syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous treatment of grammatical and speech-comprehensibility deficits in children with Down syndrome. Camarata, S., Yoder, P., Camarata, M.[2022]

Citations

1. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2023_JSLHR-22-00452

Recast Therapy for Treating Syntax in Bilingual Children ... The purpose of this study is to examine the feasibility of the delivery of complex syntax recast therapy via telepractice to Spanish–English bilingual children.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37505933/

Recast Therapy for Treating Syntax in Bilingual Children ... The purpose of this study is to examine the feasibility of the delivery of complex syntax recast therapy via telepractice to Spanish-English bilingual children.

3. udel.edu udel.edu/udaily/2023/october/development-language-disorder-recast-therapy-bilingual-children/

Helping bilingual children | UDaily An intensive language therapy program is also underway for preschool-aged children with developmental language disorder (DLD) at the University of Delaware.

4. withpower.com withpower.com/trial/phase-language-disorders-7-2023-316a1

Language Intervention for Developmental ... Research shows that conversational recast treatment helps children with language impairments learn grammar faster and more effectively than other methods. It ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10171084/

What predicts individual response to language treatment in ... Present study. The present study explores predictors of treatment response in a group of school-age Spanish-English bilingual children with DLD ...

6. withpower.com withpower.com/trial/phase-language-development-disorders-10-2024-7e097?condition=&query=Language+Therapy&overallStatus=Recruiting&hasNoPlacebo=false

Sentence Recast for Language Developmental Disorders The research articles reviewed do not provide specific safety data for Sentence Recast therapy, but they focus on its effectiveness in improving language skills ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06085300

Study Details | The Relationship Between Child Language ... Experimental : sentence recast - Bilingual (Spanish+English) intervention. Treatment will differ from monolingual therapy in that the child will be seen by two ...