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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized clinical trial that uses a Sequential Multiple Assignment Randomized Trial (SMART) study design. The study will directly compare the efficacy of an innovative intervention that combines explicit and implicit approaches to a traditional implicit treatment approach to teach true grammatical forms to children with developmental language disorder (DLD). The study will also compare interventions that include sequences of Explicit-added and Implicit-only treatments. Participants will include 5- through 9-year-old children with DLD who present with significant grammatical weaknesses. In Phase 1, 155 participants will be randomized 1:1 to an Explicit-added treatment group or an Implicit-only treatment group. Each participant will complete 32 sessions targeting four unique grammatical forms (8 sessions/form). In Phase 2, "Masters" will be re-randomized to receive no treatment 32 sessions of the same treatment, or 32 sessions of the alternative treatment. "Non-Masters" will be re-randomized to receive 32 additional sessions of the same treatment or 32 sessions of the alternative treatment. Performance will be measured on acquisition, maintenance, and generalization probes obtained immediately,1-, 6-, and 12- months post-intervention. The SMART study design will be used to determine if child factors, including expressive and receptive language abilities, nonverbal IQ, and executive function skills can reliably predict the treatment sequence that optimizes language learning. Study results will help to determine the best sequence approach to ameliorate grammatical weaknesses, one of the core deficits of young children with language impairment.

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 Explicit Approach for Language Disorders treatment?

Research on sudden gains in psychological treatments, like cognitive behavior therapy for depression, shows that sudden improvements can lead to better outcomes. This suggests that treatments focusing on sudden gains, like the Explicit Approach, might also be effective for language disorders. ^{1 2 3 4 5}

How is the Explicit-added treatment for language disorders different from other treatments?

The Explicit-added treatment for language disorders is unique because it focuses on making children consciously aware of language patterns, unlike traditional methods that rely on implicit learning (learning without conscious awareness). This approach has shown significant improvements in teaching grammatical forms and past tense marking in children with developmental language disorders. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

References

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

When and how assessment matters: An update on the Treatment Utility of Clinical Assessment (TUCA). [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sudden gains in behavioural activation for depression. [2014]

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

A method for conducting intensive psychological studies with early-onset chronically depressed patients. [2019]

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

A Revised Theory of Sudden Gains in Psychological Treatments. [2021]

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

Outcome measures for practice. [2015]

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

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

7. United States 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. [2022]

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

Evaluation of a Combined Explicit-Implicit Approach to Teach Grammatical Forms to Children With Grammatical Weaknesses. [2021]

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

An Implicit-Explicit Framework for Intervention Methods in Developmental Language Disorder. [2023]

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

Remediation of children with developmental language disorders. [2019]