Back to resultsEvaluation of an Explicit Approach
Primary Purpose
Developmental Language Disorder, Explicit Intervention, Grammatical Language
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implicit-only
Explicit-added
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Language Disorder focused on measuring Child Language, Randomized Control Trial, Intervention, Grammar, Morphology
Eligibility Criteria
Inclusion Criteria:
Study participants will include children with language impairment, aged 5 through 8 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.
Exclusion Criteria:
Participants will be excluded if there is no indication of language impairment, and they are not aged 5 through 8 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.
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Explicit Master Plus No Additional Treatment
Explicit Master Plus Explicit Treatment
Explicit Master Plus Implicit Treatment
Explicit Non-Master Plus Explicit Treatment
Explicit Non-Master Plus Implicit Treatment
Implicit Master Plus No Additional Treatment
Implicit Master Plus Implicit Treatment
Implicit Master Plus Explicit Treatment
Implicit Non-Master Plus Implicit Treatment
Implicit Non-Master Plus Explicit Treatment
Arm Description
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of explicit treatment.
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of implicit treatment.
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of explicit treatment.
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of implicit treatment.
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of implicit treatment.
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of explicit treatment.
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of implicit treatment.
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of explicit treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04902508
Brief Title
Evaluation of an Explicit Approach
Official Title
Evaluation of an Explicit Approach to Teach Grammatical Forms to Children With Language Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder, Explicit Intervention, Grammatical Language
Keywords
Child Language, Randomized Control Trial, Intervention, Grammar, Morphology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This study uses a sequential multiple assignment randomized trial (SMART) design with two phases of randomization.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Explicit Master Plus No Additional Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Arm Title
Explicit Master Plus Explicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of explicit treatment.
Arm Title
Explicit Master Plus Implicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of implicit treatment.
Arm Title
Explicit Non-Master Plus Explicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of explicit treatment.
Arm Title
Explicit Non-Master Plus Implicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of implicit treatment.
Arm Title
Implicit Master Plus No Additional Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Arm Title
Implicit Master Plus Implicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of implicit treatment.
Arm Title
Implicit Master Plus Explicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of explicit treatment.
Arm Title
Implicit Non-Master Plus Implicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of implicit treatment.
Arm Title
Implicit Non-Master Plus Explicit Treatment
Arm Type
Experimental
Arm Description
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of explicit treatment.
Intervention Type
Behavioral
Intervention Name(s)
Implicit-only
Intervention Description
Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment.
Intervention Type
Behavioral
Intervention Name(s)
Explicit-added
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grammatical Language Probe
Description
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.
Time Frame
After 32 sessions or approximately 4 months.
Secondary Outcome Measure Information:
Title
Structured Photographic Picture Language Test - 3 (SPELT-3)
Description
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.
Time Frame
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Title
Mean Length of Utterance - Morphemes (MLU-m)
Description
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.
Time Frame
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Title
Developmental Sentence Scoring (DSS)
Description
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.
Time Frame
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Title
Grammatical Language Probe
Description
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.
Time Frame
After 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lizbeth H Finestack, PhD
Phone
612-624-6090
Email
finestack@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizbeth H Finestack, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
De-identified data, metadata, and analysis information will be shared publicly online. Access will not be restricted.
Learn more about this trial
Evaluation of an Explicit Approach
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