Explicit Approach for Language Disorders

Overseen By Lizbeth H Finestack, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Autism, Down syndrome, Seizure, others

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

Compensation: Varies

Number of Visits: 64

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different teaching methods can help children with developmental language disorder (DLD) improve their grammar. Participants will receive either a combination of explicit (direct) and implicit (indirect) teaching, known as the Explicit-added treatment, or just implicit teaching, referred to as the Implicit-only treatment, to determine which is more effective. The goal is to identify which approach best helps children with DLD learn and maintain better grammatical skills over time. The study seeks children aged 5 to 9 years who have significant trouble using grammar but do not have other conditions like autism or hearing problems. As an unphased trial, this study offers a unique opportunity to contribute to educational research that could benefit children with DLD worldwide.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that specific language teaching methods can be effective and safe for children with developmental language disorders (DLD). Studies comparing direct teaching (explicit) and indirect learning (implicit) found that children learned and remembered grammar better with direct teaching.

In indirect learning, children acquire language skills without full awareness. Research on this method has produced mixed results; some studies found it helpful, while others did not observe significant improvement in language skills.

Both direct and indirect methods have been studied and are generally well-received by children. No major safety concerns have been reported for either method, suggesting both approaches are safe options for helping children with DLD improve their language skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different techniques to tackle language disorders, focusing on both implicit and explicit methods. Unlike traditional therapies that may rely heavily on one type of treatment approach, this trial investigates how a combination of implicit and explicit treatments might improve outcomes. By tailoring the treatment based on a patient's mastery of skills, this study aims to discover a more personalized and potentially more effective way to manage language disorders. The goal is to find out if mixing these methods can accelerate progress and provide better, longer-lasting results for people with language challenges.

What evidence suggests that this trial's treatments could be effective for developmental language disorder?

Research has shown that both direct and indirect teaching methods can improve language skills in children with developmental language disorder (DLD). In this trial, participants may receive either the Explicit-added treatment or the Implicit-only treatment. Studies have found that combining these methods enhances children's understanding of grammar, which is often challenging for those with DLD. One review found that direct teaching led to significant progress in both speaking and understanding language. In contrast, methods relying solely on natural language exposure might not yield as much improvement. Evidence suggests that direct methods provide stronger support for children struggling with grammar. Overall, the data supports the idea that using both methods together could be more beneficial than using only indirect methods. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 5-9 with developmental language disorder (DLD) and grammatical weaknesses. They must be native English speakers, have typical hearing and vision (with correction if needed), and not have conditions like autism or Down syndrome that could explain their language issues.

Inclusion Criteria

More than half of what you say during a 20-minute conversation includes the right subject and verb combinations.

I speak Mainstream American English.

You do not have significant problems with thinking or memory.

Exclusion Criteria

You have a significant delay in thinking and understanding.

You should not have trouble using certain types of grammar, like using "s" at the end of words, adding "ed" to the end of words, or using "is/are" and "do/does" in sentences.

You have unusual hearing or vision, but it can be corrected with glasses or hearing aids if needed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants are randomized to either Explicit-added or Implicit-only treatment groups, completing 32 sessions targeting grammatical forms

8 months

32 sessions

Phase 2 Treatment

Participants are re-randomized based on mastery level to receive additional treatment sessions or no further treatment

8 months

32 sessions

Follow-up

Participants are monitored for acquisition, maintenance, and generalization of grammatical forms post-intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Explicit-added
• Implicit-only

Trial Overview

The study compares two treatments for DLD: one that adds explicit grammar teaching to the usual implicit approach, versus an implicit-only method. Kids will get randomized to start with one treatment, then possibly switch based on their progress in learning grammar.

How Is the Trial Designed?

Group I: Implicit Non-Master Plus Implicit Treatment Experimental Treatment 1 Intervention

Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of implicit treatment.

Group II: Implicit Non-Master Plus Explicit Treatment Experimental Treatment 2 Interventions

Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of explicit treatment.

Group III: Implicit Master Plus No Additional Treatment Experimental Treatment 1 Intervention

Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.

Group IV: Implicit Master Plus Implicit Treatment Experimental Treatment 1 Intervention

Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of implicit treatment.

Group V: Implicit Master Plus Explicit Treatment Experimental Treatment 2 Interventions

Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of explicit treatment.

Group VI: Explicit Non-Master Plus Implicit Treatment Experimental Treatment 2 Interventions

Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of implicit treatment.

Group VII: Explicit Non-Master Plus Explicit Treatment Experimental Treatment 1 Intervention

Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of explicit treatment.

Group VIII: Explicit Master Plus No Additional Treatment Experimental Treatment 1 Intervention

Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.

Group IX: Explicit Master Plus Implicit Treatment Experimental Treatment 2 Interventions

Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of implicit treatment.

Group X: Explicit Master Plus Explicit Treatment Experimental Treatment 1 Intervention

Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of explicit treatment.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The tutorial discusses how different intervention characteristics, such as instructions and feedback, can influence whether learning is implicit or explicit, which is important for tailoring effective interventions.

Clinicians should recognize that most interventions tend to engage the explicit learning system, even those designed for implicit learning, and understanding this can help them select the best approach for specific behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Implicit-Explicit Framework for Intervention Methods in Developmental Language Disorder. Baron, LS., Arbel, Y.[2023]

Using outcome measures in psychotherapy can significantly improve treatment results, especially for patients who are likely to struggle with negative outcomes.

A meta-analysis indicates that monitoring patient feedback and providing clinicians with decision-making tools can enhance treatment effectiveness for those showing early signs of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for practice. Whipple, JL., Lambert, MJ.[2015]

In a study of 40 adults with depression undergoing up to 12 sessions of behavioral activation treatment, 42.5% experienced sudden gains, which occurred early in the treatment process (median session 2).

Those who had sudden gains showed significantly lower depression scores post-treatment and a higher likelihood of achieving reliable and clinically significant improvement, indicating that sudden gains are linked to better therapy outcomes in behavioral activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden gains in behavioural activation for depression. Masterson, C., Ekers, D., Gilbody, S., et al.[2014]

The study introduces a new methodology to evaluate the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) for treating outpatients with early onset chronic depression, focusing on how well patients learn from therapy.

By measuring patient learning and its impact on treatment outcomes, the research suggests that understanding and applying what is taught in psychotherapy can help resolve chronic psychological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method for conducting intensive psychological studies with early-onset chronically depressed patients. McCullough, JP., Lord, BD., Conley, KA., et al.[2019]

Sudden gains in cognitive therapy, first identified by Tang and DeRubeis in 1999, are significant predictors of better treatment outcomes for depression and have been observed across various psychological treatments and disorders.

The authors propose a revised theory of sudden gains that incorporates new empirical findings from the last 20 years, detailing predictors, processes leading to sudden gains, and their impact on treatment outcomes, which could enhance both research and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Revised Theory of Sudden Gains in Psychological Treatments. Aderka, IM., Shalom, JG.[2021]

The Treatment Utility of Clinical Assessment (TUCA) should be examined in a more contextualized manner, focusing on specific conditions that determine how assessments can enhance treatment processes and patient outcomes.

A heuristic model is proposed to differentiate between direct benefits of assessments and indirect treatment utility, highlighting the need for clear theoretical frameworks and variability in mediating variables to improve research designs and clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When and how assessment matters: An update on the Treatment Utility of Clinical Assessment (TUCA). Kamphuis, JH., Noordhof, A., Hopwood, CJ.[2021]

Interventions for children with developmental language disorders vary widely and are based on different theoretical perspectives, highlighting the need for tailored approaches.

Neuropsychologically driven remediation focuses on customizing interventions to align with a child's unique cognitive and linguistic strengths and weaknesses, providing specific compensatory techniques for effective support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remediation of children with developmental language disorders. Dunn, M.[2019]

A study involving three children with autism spectrum disorder (ASD) showed that a combined explicit-implicit intervention significantly improved their accuracy in using grammatical forms after just a few treatment sessions.

The improvements in grammatical accuracy were maintained for up to 2 months post-treatment for two of the three participants, suggesting that this intervention could be effective for teaching grammar to children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Combined Explicit-Implicit Approach to Teach Grammatical Forms to Children With Grammatical Weaknesses. Finestack, L., Engman, J., Huang, T., et al.[2021]

The study demonstrated that a targeted intervention using the SHAPE CODING system significantly improved past tense marking in 21 children with developmental language disorder (DLD) over 10 weeks, with a large effect size (d = 3.03).

Improvements in past tense production were maintained for at least 5 weeks after the intervention, indicating the long-term efficacy of this explicit grammar intervention for early school-age children with DLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of an Explicit Intervention Approach to Improve Past Tense Marking for Early School-Age Children With Developmental Language Disorder. Calder, SD., Claessen, M., Ebbels, S., et al.[2022]

In a study involving 25 children aged 5 to 8 with developmental language disorder, those who received explicit-implicit instruction (E-I) showed a significant advantage in learning new grammatical forms compared to those who received only implicit instruction (I-O).

The E-I group not only acquired the grammatical forms more effectively but also maintained and generalized their learning better, indicating that explicit instruction can enhance language learning outcomes for children with language impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Explicit Intervention to Teach Novel Grammatical Forms to Children With Developmental Language Disorder. Finestack, LH.[2019]

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