NCT01829360

Brief Summary

This research attempts to adapt and optimize a word learning treatment, specifically interactive book reading, for use with Kindergarten children with Specific Language Impairment (SLI). Children with SLI have difficulty learning language without any obvious cause for this difficulty. This study will examine the best way to achieve the appropriate intensity of 36 exposures. For example, is it better to hear the new words many times within the book (high dose) and to read the book few times (low dose frequency), or is it better to hear the new words a few times within the book (low dose) and to read the book many times (high dose frequency). The investigators hypothesize that reading the books many times will be more effective than repeating the words many times within a book.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 14, 2019

Completed
Last Updated

November 14, 2019

Status Verified

October 1, 2019

Enrollment Period

5.4 years

First QC Date

March 12, 2013

Results QC Date

September 24, 2019

Last Update Submit

October 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Words Known From Pre- to Post-treatment

    In each of the two treatments, children are taught 30 new words and tested on their ability to provide a definition of each word. Definitions are scored as 0 points for an incorrect or absent definition, 1 point for an appropriate use of the word in a sentence or for a vague definition, 2 points for a conventional definition containing at least one critical element but lacking other critical elements, and 3 points for a complete and accurate definition including all critical elements. For the analyses, children's definitions scored as 2 or 3 (i.e., a partially or completely accurate definition) were counted as correct (i.e., the child knows the word) and definitions scored as 0 or 1 (i.e., incorrect definition, absent definition, correct use of a word in a sentence, or vague definition) were counted as incorrect (i.e., the child does not know the word). Thus, children's scores could range from 0 to 30 words known, with higher scores indicating better outcomes.

    Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)

Secondary Outcomes (2)

  • Interim Definition

    Treatment lasted 5-12 weeks. Data was taken during this time.

  • Interim Naming

    Administered during treatment, which lasted 5-12 weeks

Study Arms (4)

Standard then Alternative: High Dose

EXPERIMENTAL

Children in this arm are assigned to the standard treatment for the first round of intervention (dose 6 x dose frequency 6) and then the alternative treatment that maximizes dose (dose 9 x dose frequency 4)

Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)

Alternative: High Dose then Standard

EXPERIMENTAL

Children in this arm are assigned to the alternative treatment that maximizes dose (dose 9 x dose frequency 4) in the first round of intervention and then to the standard treatment for the second round of intervention (dose 6 x dose frequency 6)

Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)

Alternative: High Dose Frequency then Standard

EXPERIMENTAL

Children in this arm are assigned to the alternative treatment that maximizes dose frequency (dose 4 x dose frequency 9) in the first round of intervention and then to the standard treatment for the second round of intervention (dose 6 x dose frequency 6)

Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)

Standard then Alternative: High Dose Frequency

EXPERIMENTAL

Children in this arm are assigned to the standard treatment for the first round of intervention (dose 6 x dose frequency 6) and then the alternative treatment that maximizes dose frequency (dose 4 x dose frequency 9)

Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)

Interventions

Children receive 2 rounds of treatment with interactive book reading. Each treatment teaches 30 words that the children do not know. Treatments vary in dose (the number of times the words is heard/taught in an individual book reading session: 4 vs. 6 vs. 9) and dose frequency (the number of times book reading sessions are repeated: 4 vs. 6. vs. 9). Across all dose x dose frequency combinations, children hear/are taught the 30 words 36 times, which has been shown to be the adequate overall intensity of the intervention.

Also known as: Interactive book reading, Dialogic reading, Shared book reading
Alternative: High Dose Frequency then StandardAlternative: High Dose then StandardStandard then Alternative: High DoseStandard then Alternative: High Dose Frequency

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Eligible for Kindergarten enrollment
  • Age 5 to 6 years
  • Normal hearing
  • Nonverbal Intelligence Quotient (IQ) of 85 or higher on the Reynolds Intellectual Assessment Scale
  • Score below 82 on the Clinical Evaluation of Language Fundamentals
  • Score at or below the 10% percentile on one of the approved standardized vocabulary assessments.

You may not qualify if:

  • Speaks more than one language
  • Health history indicating neurologic or other disorder that would exclude a diagnosis of SLI (e.g., autism, developmental disability, seizure disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Specific Language Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Language Development DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

No limitations noted.

Results Point of Contact

Title
Holly Storkel
Organization
University of Kansas

Study Officials

  • Holly Storkel

    University of Kansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research assistants that collect and score the pre/post outcomes are blind to arm assignment.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

April 11, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 14, 2019

Results First Posted

November 14, 2019

Record last verified: 2019-10

Locations