Efficacy of AMALS in Treating Language Impairment in Children

• Sponsor: Lamar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00840060
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 40
• Locations: 3
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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. This study will target preschool children with language impairment living in a region characterized by nonmainstream dialects.

Questions driving this work are:

1. 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?

2. Will these gains be maintained at one-month follow up?

3. 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.

Condition or Disease	Intervention/Treatment	Phase
Language Disorder	Behavioral: AMALS; Behavioral: DTA	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: AMALS: Addressing Multiple Aspects of Language Simultaneously: A Randomized Clinical Trial
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMALS Addressing multiple aspects of language simultaneously	Behavioral: AMALS; Addressing multiple aspects of language simultaneously
Experimental: DTA Discrete Trial Approach	Behavioral: DTA; Discrete Trial Approach

Outcome Measures

Primary Outcome Measures

1. Language Sample Analysis [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.

2. Number of Verb Structures Per Utterance [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;

2. 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)

3. Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, & Lorge, 1972);

4. Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper & de Villiers, 2005);

5. Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner & Kresheck, 1983);

6. Documentation from teachers and/or parents of impressions of language status in comparison with peers;

7. 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).

Exclusion Criteria:

1. English as the primary language

2. No oral-motor impairment

3. No hearing impairment

4. No co-morbid psychiatric or neurological impairments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Orange Cove Consolidated Independent School District	Orange	Texas	United States	77631
2	Little-Cypress Mauriceville Consolidated School District	Orange	Texas	United States	77632
3	Port Arthur Independent School District	Port Arthur	Texas	United States	77640

Sponsors and Collaborators

• Lamar University
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Monica L Bellon-Harn, Ph.D., Lamar University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Monica L. Harn, Associate Professor, Speech and Hearing Services, Lamar University
• ClinicalTrials.gov Identifier: NCT00840060
• Other Study ID Numbers: RDC009027A-01A2; 1R15DC009027-01A2; NIDCD RDC009027A-01A2
• First Posted: Feb 10, 2009
• Last Update Posted: May 15, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Language Disorders

Study Results

Participant Flow

Recruitment Details	Children were recruited at three public school sites. From January 2009 to May 2010, 50 participants were successfully recruited. Of the 50, 40 met inclusion criteria and were randomly assigned to one of the two treatments.
Pre-assignment Detail	No participants were excluded from the treatment following enrollment.

Arm/Group Title	Addressing Multiple Aspects of Language Simultaneously	Discrete Trial Approach
Arm/Group Description	Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.	Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
Period Title: Overall Study
STARTED	20	20
COMPLETED	19	19
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Addressing Multiple Aspects of Language Simultaneously	Discrete Trial Approach	Total
Arm/Group Description	Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.	Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.56 (.50)	4.90 (.51)	4.74 (.53)
Sex: Female, Male (Count of Participants)
Female	9 45%	6 30%	15 37.5%
Male	11 55%	14 70%	25 62.5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Language Sample Analysis
Description	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.
Time Frame	Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Addressing Multiple Aspects of Language Simultaneously	Discrete Trial Approach
Arm/Group Description	Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.	Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
Measure Participants	19	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)
Frequency of copula (is/are): 1-month follow-up	76.94 (25.72)	75.81 (23.55)
Frequency of auxiliary (is/are): pre-treatment	40.11 (38.87)	48.87 (35.13)
Frequency of auxiliary (is/are): post-treatment	65.23 (23.73)	59.12 (26.02)
Frequency of auxiliary (is/are): 1-month follow-up	50.23 (34.15)	48.68 (24.51)

2. Primary Outcome

Title	Number of Verb Structures Per Utterance
Description	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.
Time Frame	Pre-treatment, post-treatment, 1-month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Addressing Multiple Aspects of Language Simultaneously	Discrete Trial Approach
Arm/Group Description	Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.	Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
Measure Participants	19	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

Arm/Group Title	Addressing Multiple Aspects of Language Simultaneously		Discrete Trial Approach
Arm/Group Description	Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.		Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
All Cause Mortality
	Addressing Multiple Aspects of Language Simultaneously		Discrete Trial Approach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Addressing Multiple Aspects of Language Simultaneously		Discrete Trial Approach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Addressing Multiple Aspects of Language Simultaneously		Discrete Trial Approach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

Problems with stratification according to dialect prior to randomization lead to difficulty interpreting results related to dialect

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.