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Developmental Language DisorderNCT04902508

Evaluation of an Explicit Approach

A study testing Implicit-only and Explicit-added in people with Developmental Language Disorder and Explicit Intervention, run by University of Minnesota at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 5 to 9 years
What is being tested?
Implicit-only and Explicit-added
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteUnited States
Study dates
15 Feb 2022to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Study participants will include children with language impairment, aged 5 through 9 years. Participants will not have any indication of other significant conditions to which their impairment may be attributed, such as autism spectrum disorder, Down syndrome, seizure disorder, or hearing impairment. Participants with a diagnosis of attention deficit/hyperactivity disorder will be included due to high rate of co-morbidity (see Redmond, 2016). Additionally, participants will meet the following criteria:
  • No evidence of significant cognitive delay;
  • Evidence of language impairment;
  • Evidence of deficits on expressive grammatical forms: score below 30% accuracy on at least two of the following forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions;
  • Typical hearing and vision, with correction if necessary;
  • Native English speaker with English spoken in the home by at least one primary caregiver since birth;
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  • Speaker of Mainstream American English;
  • Be able to articulate final-position phonemes /s/, /z/, /t/, and /d/; and
  • Majority of utterances (> 50%) include subject and verb in obligated contexts based on a 20-min conversational language sample to ensure appropriateness of study intervention.

Who cannot join

  • Participants will be excluded if there is no indication of language impairment, and they are not aged 5 through 9 years. Participants will also be excluded if there is indication of other significant conditions to which their impairment may be attributed, such as autism spectrum disorder, Down syndrome, seizure disorder, or hearing impairment. Additionally, participants will be excluded in they meet the following criteria:
  • Evidence of significant cognitive delay;
  • No evidence of deficits on expressive grammatical forms: score below 30% accuracy on at least two of the following forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions;
  • Atypical hearing and vision, with correction if necessary;
  • Non-native English speaker;
  • Speaker of Non-mainstream American English;
  • Unable to articulate final-position phonemes /s/, /z/, /t/, and /d/; and
  • Non-majority of utterances (< 50%) include subject and verb in obligated contexts based on a 20-min conversational language sample to ensure appropriateness of study intervention.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Evaluation of an Explicit Approach to Teach Grammatical Forms to Children With Language Impairment

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.

Read the detailed description

This study is a randomized trial with two phases. Phase 1 is a traditional randomized trial during which eligible and consenting participants will be randomized equally to one of two interventions: Explicit-added or Implicit-only. Randomization is blocked by age (5- \& 6-year-olds; and 7- to 9-year-olds) and receptive language ability to ensure that ages are matched across groups and that half of the participants in each treatment group have receptive language skills below average. A standard score of 80 is used to categorize participants (below average: < 80; average: ≥ 80) based on the Receptive Language Index of the Clinical Evaluation of Language Fundamentals (CELF). Participants are also stratified based on child gender. All participants will complete 32 sessions (8 sessions per target in blocks of 4). In Phase 2, participants in both the Explicit-added and Implicit-only groups will be re-randomized based on level of mastery on treatment goals. Participants who are considered treatment "Masters" and have achieved the criterion of 80% accuracy on all target forms will be re-randomized to receive no further treatment or a round of the alternative treatment. Participants who have not yet mastered each of the four target forms (< 80% accuracy) will be re-randomized to receive another round of either the same treatment or the alternative treatment.

Study participants will include 155 children with language impairment, aged 5 through 9 years, accounting for a 10% attrition rate resulting in 140 participants. This age includes children who likely experience difficulties with the grammatical forms targeted in intervention and who are receiving intervention for weaknesses in grammatical language. Researchers will recruit participants with an effort to maximize participant diversity based on ethnicity and parental education. We aim to recruit a representative sample of children with DLD, which will include more boys than girls. Participants will not have any indication of other significant conditions to which their impairment may be attributed, such as autism spectrum disorder, Down syndrome, seizure disorder, or hearing impairment. Participants with a diagnosis of attention deficit/hyperactivity disorder will be included due to high rate of co-morbidity.

Being tested
Implicit-only, Explicit-added
Keywords
Child Language, Randomized Control Trial, Intervention, Grammar, Morphology
Medical subject headings
Language Development Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implicit-onlyBehavioural

    Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment.

  • Explicit-addedBehavioural

    Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment. Interventionists will also present the rule/pattern guiding the target form.

Study groups in NCT04902508
Study groupRoleWhat they receive
Explicit Master Plus No Additional TreatmentExperimentalReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Receives: Behavioral: Explicit-added
Explicit Master Plus Explicit TreatmentExperimentalReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of explicit treatment.
Receives: Behavioral: Explicit-added
Explicit Master Plus Implicit TreatmentExperimentalReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of implicit treatment.
Receives: Behavioral: Implicit-only; Behavioral: Explicit-added
Explicit Non-Master Plus Explicit TreatmentExperimentalReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of explicit treatment.
Receives: Behavioral: Explicit-added
Explicit Non-Master Plus Implicit TreatmentExperimentalReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of implicit treatment.
Receives: Behavioral: Implicit-only; Behavioral: Explicit-added
Implicit Master Plus No Additional TreatmentExperimentalReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Receives: Behavioral: Implicit-only
Implicit Master Plus Implicit TreatmentExperimentalReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of implicit treatment.
Receives: Behavioral: Implicit-only
Implicit Master Plus Explicit TreatmentExperimentalReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of explicit treatment.
Receives: Behavioral: Implicit-only; Behavioral: Explicit-added
Implicit Non-Master Plus Implicit TreatmentExperimentalReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of implicit treatment.
Receives: Behavioral: Implicit-only
Implicit Non-Master Plus Explicit TreatmentExperimentalReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of explicit treatment.
Receives: Behavioral: Implicit-only; Behavioral: Explicit-added

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grammatical Language Probe

    The primary outcome measure will be the change in percentage correct on the Grammatical Language Probe from pre- to post-intervention. The researcher-developed 64-item probe contains 8 contrastive pairs of each of the four target forms. Half of the verbs used in the sentence pairs will comprise verbs intentionally included in session models and recasts; half will include verbs not intentionally included in models and recasts. Participants will be shown a picture and prompted to describe the picture using the target form. Scores will range from 0-64, with higher indicating better performance. Percent correct will be used in analyses.

    Measured: After 32 sessions or approximately 4 months.

Secondary outcomes (4)
  1. Structured Photographic Picture Language Test - 3 (SPELT-3)

    The SPELT-3 includes 54 full color photographs of everyday situations and objects paired with simple verbal questions and statements to elicit 22 morphological and syntactic structures. Standard scores (mean = 100; SD = 15) will be used in analyses.

    Measured: After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention

  2. Mean Length of Utterance - Morphemes (MLU-m)

    The MLU-m will be derived from a 20-min language sample with a researcher. MLU-m may range from 0 and on. Higher MLU-m typically reflects greater sentence complexity. MLU-m will be used in study analyses.

    Measured: After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention

  3. Developmental Sentence Scoring (DSS)

    The DSS will be derived from a 20-min language sample with a researcher. The DSS may range from 0 to 8. Higher DSS scores typically reflects greater sentence complexity. The average DSS will be used in study analyses.

    Measured: After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention

  4. Grammatical Language Probe

    The primary outcome measure will be the change in percentage correct on the Grammatical Language Probe. The researcher-developed 64-item probe contains 8 contrastive pairs of each of the four target forms. Half of the verbs used in the sentence pairs will comprise verbs intentionally included in session models and recasts; half will include verbs not intentionally included in models and recasts. Participants will be shown a picture and prompted to describe the picture using the target form. Scores will range from 0-64, with higher indicating better performance. Percent correct will be used in analyses.

    Measured: After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start15 Feb 2022
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This study uses a sequential multiple assignment randomized trial (SMART) design with two phases of randomization.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04902508
Sponsor's protocol ID
R01DC019374-01
Other IDs
R01DC019374-01
Status last verified
Aug 2026
First submitted
17 May 2021
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only de-identified data will be shared. Identifying information will be stripped and kept confidential. Data that will be stored includes performance raw and standard scores on all assessments and de-identified written transcripts of language samples obtained. Participants will be given information regarding data sharing and will consent to data sharing.

Questions about this trial

What is this clinical trial studying?

A study testing Implicit-only and Explicit-added in people with Developmental Language Disorder and Explicit Intervention, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grammatical Language Probe (time frame: After 32 sessions or approximately 4 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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