Specific Language ImpairmentNCT01829360
Accelerating Word Learning in Children With Language Impairment
A study testing Treatment (interactive book reading, dialogic reading, shared book reading) in people with Specific Language Impairment, run by University of Kansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Specific Language Impairment
- What is being tested?
- Treatment (interactive book reading, dialogic reading, shared book reading)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interactive Book Reading to Accelerate Word Learning by Children With SLI
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.
Read the detailed description
Specific Language Impairment (SLI) affects approximately 7.4% of Kindergarten children. Children with SLI are known to have difficulty learning new words, which places them at greater risk for future reading impairments and academic failure. Surprisingly, there are few interventions for word learning by children with SLI that have undergone rigorous efficacy and/or effectiveness testing. The goal of this research is to optimize an interactive book reading intervention that has proven to be successful in teaching vocabulary to other groups of Kindergarten children. A secondary goal was to examine whether pre-treatment characteristics predicted how many words children would learn.
This study further tests the adequate intensity of 36 exposures. Each child will receive two treatments at the identified adequate intensity. Children were randomized to two treatments: the standard treatment and 1 of 2 alternative treatments. The standard treatment used in prior research was balanced between the amount of times the new word is heard within the book (dose 6) and the amount of times the book is read (dose frequency 6). The alternative treatments were more heavily weighted for either repetitions within the book (high dose/low dose frequency, i.e., dose 9 x dose frequency 4) or the amount of times the book is read (low dose/high dose frequency, i.e., dose 4 x dose frequency 9). Ultimately, this study determines how best to achieve the adequate intensity of 36 exposures.
A secondary goal was to further examine the pre-treatment factors associated with the number of words learned by children with SLI during interactive book reading. We once again explore a variety of potential predictors including those that were significant in a prior study (i.e., phonological awareness, nonword repetition, and semantics) as well as those that were not significant in a prior study but that had the potential to be related to a child's ability to learn during interactive book reading. That is, a child's general language abilities (as measured by the Clinical Evaluation of Language Fundamentals-4, CELF-4, Core Language score) and their ability to understand verbally presented stories (as measured by the CELF-4 Understanding Spoken Paragraphs score) could impact their success in encoding new words during interactive book reading.
- Conditions
- Specific Language Impairment
- Being tested
- Treatment (interactive book reading, dialogic reading, shared book reading)
- Medical subject headings
- Specific Language Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (interactive book reading, dialogic reading, shared book reading)Behavioural
Also called Interactive book reading, Dialogic reading, Shared book reading
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)
Secondary outcomes (2)
Interim Definition
Learning also was tracked during treatment. The research assistant who provided the treatment prompted children to provide definitions at four points during each treatment. Depending on the arm, the four test points corresponded to 6-9 exposures, 18-20 exposures, 27-30 exposures, and 36 exposures.The words were assessed in a fixed order while the child viewed the pre-reading pictures for each word. The research assistant asked, "What does [word] mean?". Specific feedback was not provided but the correct definition always was provided after the child's response regardless of the accuracy of the response. Scoring was the same as that described for definitions administered pre/post. Scores could range from 0-30 words correctly defined.
Measured: Treatment lasted 5-12 weeks. Data was taken during this time.
Interim Naming
Learning also was tracked during treatment. The research assistant who provided the treatment prompted children to name the target words at four points during each treatment. Depending on the arm, the four test points corresponded to 6-9 exposures, 18-20 exposures, 27-30 exposures, and 36 exposures. The research assistant showed the child the post-book reading picture without the orthographic label and asked a question meant to elicit the phonological form of the target word (e.g., "What is the lightning doing?" to elicit flashing). Specific feedback was not provided but the correct orthographic label and context sentence always were provided after the child's response regardless of the accuracy of the response. Responses were scored as correct (i.e., matched the target word) or incorrect (i.e., did not match the target word). Total score could range from 0 to 30 words correctly named in each treatment.
Measured: Administered during treatment, which lasted 5-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Specific Language ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Holly Storkel, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829360
- Sponsor's protocol ID
- R01DC012824
- Other IDs
- R01DC012824
- Status last verified
- Oct 2019
- First submitted
- 12 Mar 2013
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Book Reading to Accelerate Word Learning by Children With SLI
- ClinicalTrials.gov ID
- NCT01829360
- Acronym / sponsor ID
- R01DC012824
- Conditions
- Specific Language Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Mar 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Posted 14 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Language Impairment (SLI) affects approximately 7.4% of Kindergarten children. Children with SLI are known to have difficulty learning new words, which places them at greater risk for future reading impairments and academic failure. Surprisingly, there are few interventions for word learning by children with SLI that have undergone rigorous efficacy and/or effectiveness testing. The goal of this research is to optimize an interactive book reading intervention that has proven to be successful in teaching vocabulary to other groups of Kindergarten children. A secondary goal was to examine whether pre-treatment characteristics predicted how many words children would learn.
This study further tests the adequate intensity of 36 exposures. Each child will receive two treatments at the identified adequate intensity. Children were randomized to two treatments: the standard treatment and 1 of 2 alternative treatments. The standard treatment used in prior research was balanced between the amount of times the new word is heard within the book (dose 6) and the amount of times the book is read (dose frequency 6). The alternative treatments were more heavily weighted for either repetitions within the book (high dose/low dose frequency, i.e., dose 9 x dose frequency 4) or the amount of times the book is read (low dose/high dose frequency, i.e., dose 4 x dose frequency 9). Ultimately, this study determines how best to achieve the adequate intensity of 36 exposures.
A secondary goal was to further examine the pre-treatment factors associated with the number of words learned by children with SLI during interactive book reading. We once again explore a variety of potential predictors including those that were significant in a prior study (i.e., phonological awareness, nonword repetition, and semantics) as well as those that were not significant in a prior study but that had the potential to be related to a child's ability to learn during interactive book reading. That is, a child's general language abilities (as measured by the Clinical Evaluation of Language Fundamentals-4, CELF-4, Core Language score) and their ability to understand verbally presented stories (as measured by the CELF-4 Understanding Spoken Paragraphs score) could impact their success in encoding new words during interactive book reading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard then Alternative: High Dose | Experimental | Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)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) |
| Alternative: High Dose then Standard | Experimental | Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)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) |
| Alternative: High Dose Frequency then Standard | Experimental | Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)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) |
| Standard then Alternative: High Dose Frequency | Experimental | Behavioral: Treatment (interactive book reading, dialogic reading, shared book reading)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) |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment (interactive book reading, dialogic reading, shared book reading)Also: Interactive book reading, Dialogic reading, Shared book readingChildren 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. | Behavioural | Alternative: High Dose Frequency then Standard, Alternative: High Dose then Standard, Standard then Alternative: High Dose, Standard then Alternative: High Dose Frequency |
Primary outcome
Change in Words Known From Pre- to Post-treatment
Time frame: Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)
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.
2 secondary outcomes
Interim Definition
Time frame: Treatment lasted 5-12 weeks. Data was taken during this time.
Interim Naming
Time frame: Administered during treatment, which lasted 5-12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Storkel principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment (interactive book reading, dialogic reading, shared book reading) in people with Specific Language Impairment, run by University of Kansas 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 14 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Words Known From Pre- to Post-treatment (time frame: Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)). 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 14 Nov 2019.