Language DisorderPhase 2AMALSNCT00840060

Efficacy of AMALS in Treating Language Impairment in Children

A Phase 2 study testing AMALS and DTA in people with Language Disorder, run by Lamar University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this proposal is to examine the efficacy of a manualized treatment intervention, AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate semantic, morphological, and syntactic aspects of language in preschool children with language impairment. Read more about this study

Who is it for?: Ages 4 to 6 years
Conditions the study is for: Language Disorder
What is being tested?: AMALS and DTA
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesUnited States
Study dates: Jan 2009to Dec 2010
Phase: Phase 2
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 4 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;
Demonstrate sufficient phonological ability to use grammatical morphemes as determined by use of word-final /s, z, t, d/ on sound- in-word subtest from the Goldman-Fristoe Test of Articulation-2 (GFTA; Goldman \& Fristoe, 2000)
Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, \& Lorge, 1972);
Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper \& de Villiers, 2005);
Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner \& Kresheck, 1983);
Documentation from teachers and/or parents of impressions of language status in comparison with peers;
More than one standard deviation below the mean on both levels 3 and 4 of the Preschool Language Assessment Instrument (PLAI; Blank, Rose, \& Berlin, 1978).

Who cannot join

English as the primary language
No oral-motor impairment
No hearing impairment
No co-morbid psychiatric or neurological impairments

Trial locations and contacts

3 sites in 1 country.

United States3 sites

West Orange Cove Consolidated Independent School District
Orange, Texas, 77631
Little-Cypress Mauriceville Consolidated School District
Orange, Texas, 77632
Port Arthur Independent School District
Port Arthur, Texas, 77640

Other trials in United States

About this study

Official title: AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial

Questions driving this work are:

Will children participating in the AMALS treatment exhibit greater semantic, morphological, and syntactic complexity on multiple outcome measures at the completion of the intervention compared to a Discrete Trial Approach (DTA) group?
Will these gains be maintained at one-month follow up?
What is the impact of dialect on dependent variables, specifically morphosyntactic abilities?

To answer these questions a randomized clinical trial will be conducted comparing AMALS, an integrated approach to treatment, with DTA, an additive approach to therapy. In this study rather than restrict the ethnic and cultural backgrounds of this population, children's use of dialect will be uniquely identified and examined.

Conditions: Language Disorder
Being tested: AMALS, DTA
Medical subject headings: Language Disorders

What participants receive

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

AMALSBehavioural
Addressing multiple aspects of language simultaneously
DTABehavioural
Discrete Trial Approach

Study groups in NCT00840060
Study group	Role	What they receive
AMALS	Experimental	Addressing multiple aspects of language simultaneously Receives: Behavioral: AMALS
DTA	Experimental	Discrete Trial Approach Receives: Behavioral: DTA

What is being measured

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

Language Sample Analysis
Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.
Measured: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.
Number of Verb Structures Per Utterance
Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.
Measured: Pre-treatment, post-treatment, 1-month follow-up

Timeline

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

Jan 2009Dec 2010

First posted10 Feb 2009 (estimated)
Study startJan 2009
Primary completionDec 2009
Study completionDec 2010

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 Language DisorderStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00840060
Sponsor's protocol ID: RDC009027A-01A2
Other IDs: 1R15DC009027-01A2, NIDCD RDC009027A-01A2
Acronym: AMALS
Status last verified: May 2012
First submitted: 9 Feb 2009
Last updated: 15 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Language Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT00840060
Acronym / sponsor ID: AMALS / RDC009027A-01A2
Conditions: Language Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Lamar UniversityUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Study start: Jan 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2010 (actual)
First posted: 10 Feb 2009 (estimated)
Results: Posted 15 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Questions driving this work are:

Will children participating in the AMALS treatment exhibit greater semantic, morphological, and syntactic complexity on multiple outcome measures at the completion of the intervention compared to a Discrete Trial Approach (DTA) group?
Will these gains be maintained at one-month follow up?
What is the impact of dialect on dependent variables, specifically morphosyntactic abilities?

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
AMALS	Experimental	Behavioral: AMALSAddressing multiple aspects of language simultaneously
DTA	Experimental	Behavioral: DTADiscrete Trial Approach

Who may qualify

Ages: 4 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;
Demonstrate sufficient phonological ability to use grammatical morphemes as determined by use of word-final /s, z, t, d/ on sound- in-word subtest from the Goldman-Fristoe Test of Articulation-2 (GFTA; Goldman \& Fristoe, 2000)
Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, \& Lorge, 1972);
Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper \& de Villiers, 2005);
Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner \& Kresheck, 1983);

Key exclusion criteria (4 listed)

English as the primary language
No oral-motor impairment
No hearing impairment
No co-morbid psychiatric or neurological impairments

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
AMALSAddressing multiple aspects of language simultaneously	Behavioural	AMALS
DTADiscrete Trial Approach	Behavioural	DTA

Primary outcome

Language Sample Analysis
Time frame: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.
Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.
Number of Verb Structures Per Utterance
Time frame: Pre-treatment, post-treatment, 1-month follow-up
Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.

Results and safety

Results posted to the registry on 15 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Addressing Multiple Aspects of Language Simultaneously	20	19
Discrete Trial Approach	20	19

Primary outcome: Language Sample Analysis

Time frame: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.. Mean (Standard Deviation). Unit: Percentage of utterances

Measure	Addressing Multiple Aspects of Language Simultaneously n = 19	Discrete Trial Approach n = 19
Interpretive utterances: pre-treatment	17.33 (3.31)	18.00 (3.22)
Interpretive utterances: post-treatment	39.35 (4.04)	26.38 (3.92)
Interpretive utterances: 1-month follow-up	39.70 (4.16)	20.55 (4.04)
T-units: pre-treatment	52.30 (21.00)	53.77 (22.70)
T-units: post-treatment	80.94 (13.18)	69.78 (20.19)
T-units: one-month follow-up	74.88 (16.99)	55.83 (29.48)
Frequency of copula (is/are): pre-treatment	56.00 (33.24)	71.00 (33.59)
Frequency of copula (is/are): post-treatment	77.05 (26.78)	76.43 (26.12)

Population analysed: Language samples were collected for all children participating in either treatment condition.

Primary outcome: Number of Verb Structures Per Utterance

Time frame: Pre-treatment, post-treatment, 1-month follow-up. Mean (Standard Deviation). Unit: Novel verb structures per utterance

Measure	Addressing Multiple Aspects of Language Simultaneously n = 19	Discrete Trial Approach n = 19
Novel verb structures per utterance: pre-treatment	3.52 (2.26)	4.15 (2.16)
Novel verb structure per utterance: post-treatment	5.94 (1.59)	4.61 (1.78)
Novel verb structures per utterance: 1-month follo	5.41 (2.78)	4.16 (2.20)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Addressing Multiple Aspects of Language Simultaneously	0 of 20 (0%)	0 of 20 (0%)	Not reported
Discrete Trial Approach	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): Problems with stratification according to dialect prior to randomization lead to difficulty interpreting results related to dialect

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
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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.

Monica L Bellon-Harn, Ph.D. principal investigator

Lamar University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMALS and DTA in people with Language Disorder, run by Lamar University at 3 sites 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 7 inclusion and 4 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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2012). 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?

Language Sample Analysis (time frame: Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00840060.

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 15 May 2012.