Evaluation of an Explicit Approach
1 other identifier
interventional
111
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
February 5, 2026
February 1, 2026
5.5 years
May 17, 2021
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
After 32 sessions or approximately 4 months.
Secondary Outcomes (4)
Structured Photographic Picture Language Test - 3 (SPELT-3)
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Mean Length of Utterance - Morphemes (MLU-m)
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Developmental Sentence Scoring (DSS)
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Grammatical Language Probe
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Study Arms (10)
Explicit Master Plus No Additional Treatment
EXPERIMENTALReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Explicit Master Plus Explicit Treatment
EXPERIMENTALReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of explicit treatment.
Explicit Master Plus Implicit Treatment
EXPERIMENTALReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of implicit treatment.
Explicit Non-Master Plus Explicit Treatment
EXPERIMENTALReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of explicit treatment.
Explicit Non-Master Plus Implicit Treatment
EXPERIMENTALReceives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of implicit treatment.
Implicit Master Plus No Additional Treatment
EXPERIMENTALReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Implicit Master Plus Implicit Treatment
EXPERIMENTALReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of implicit treatment.
Implicit Master Plus Explicit Treatment
EXPERIMENTALReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of explicit treatment.
Implicit Non-Master Plus Implicit Treatment
EXPERIMENTALReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of implicit treatment.
Implicit Non-Master Plus Explicit Treatment
EXPERIMENTALReceives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of explicit treatment.
Interventions
Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment.
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All assessors will be blinded to intervention assignments. To reduce assessor bias, after Phases 1 and 2, two different trained research assistants unfamiliar with the participant will administer the Grammatical Language Probe. These same examiners may administer the 1-, 6-, and 12-month assessments. The PIs and board of advisors will also be blinded to intervention assignments.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 26, 2021
Study Start
February 15, 2022
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Five years after publication of the last manuscript de-identified data will be made available online via the lab website or other public data repository. Non-identifying scripts and descriptions of data analysis techniques will be made public immediately upon publication through the same methods.
- Access Criteria
- De-identified data, metadata, and analysis information will be shared publicly online. Access will not be restricted.
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.