Back to resultsMelodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism (MBCT)
Primary Purpose
Nonverbal and Low Verbal Autism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melodic-based Communication Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Nonverbal and Low Verbal Autism focused on measuring MBCT, Nonverbal autism, low verbal autism
Eligibility Criteria
Inclusion Criteria:
- Male and female children with autism ages 3-years-0-months to 10-years-11-month who meet the criterion for nonverbal (defined as less than 10 words ever spoken expressively and no functional verbal communication)
Exclusion Criteria:
- Individuals receiving other language or articulation treatments or therapy at the time of the study, unable to regularly attend four 30 min sessions of therapy weekly for 4 weeks, a history of severe hearing impairment, severe visual impairment/ blindness, a diagnosis of an organic impairment of oral or laryngeal structures, or a significant medical illness or condition which would prevent the child's participation in the treatment procedures. These conditions include, but are not limited to cerebral palsy, paraplegia, spina bifida, uncontrolled seizures, dysarthria, and amputation of arm(s).
Sites / Locations
- Loma Linda University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBCT treatment
Arm Description
Melodic-based communication treatment
Outcomes
Primary Outcome Measures
Number of spoken words
Pre/post measures include: number of words reported in home environment by parent pre-vs. post, CASL-2 Pragmatic Language raw score pre-vs. post, number of imitative attempts pre-vs. post, number of words correct in response to the question, "what is this?" and number of vocalizations in response to the question, "what is this?"
Frequency of repetitive and stereotypical behaviors
Frequency of repetitive or stereotypic movements will be analyzed in the first week of treatment (stimming behavior). This will be evaluated as follows: onset/offset and duration of the behaviors to determine frequency. This will be evaluated by an independent observer through video analysis.
Secondary Outcome Measures
Full Information
NCT ID
NCT04679974
First Posted
December 17, 2020
Last Updated
December 21, 2020
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT04679974
Brief Title
Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism
Acronym
MBCT
Official Title
Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism Ages: 3:0 - 10:11
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 17, 2018 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
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
The purpose of this study is to determine the efficacy of Melodic Based Communication Therapy (M.B.C.T.) for increasing oral expressive skills in nonverbal children with autism spectrum disorders. MBCT has previously been shown to facilitate an improvement in expressive vocabulary, verbal imitative abilities, number of vocalizations, and social language development in nonverbal children with autism ages 5-7. However, earlier studies were small and did not examine the effects of M.B.C.T. on a younger and older population. This study will examine its effectiveness across a broader sample group. Additionally, this study will examine further predictors of success including but not limited to chronological age, developmental age, the frequency of repetitive/stereotypic behaviors, receptive language score, and social language score.
Detailed Description
The study will be a repeated measures design as assessments will be taken at baseline and on a weekly basis (baseline, weeks 1-4). All participants in the study will receive Melodic Based Communication Therapy (M.B.C.T.). General procedures involved in (M.B.C.T.) are as follows: 25 common first words are selected as the targets (e.g., apple, ball, car, dog, cat, eat, go, etc.). Pictures and objects will be used as stimulus items. The top 3-5 incentives as identified by parent survey will be given according to the therapies specific reinforcement schedule. All treatment and evaluation sessions will be videotaped for future/further analysis and verification purposes. For the purposes of the study design, the same 25 words will be used for all participants.
4. Subjects will be male and female children diagnosed with autism.
5. Subjects will be between 3 years 0 months and 10 years 11 months of age.
6. In total, subject participation will last approximately 4 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonverbal and Low Verbal Autism
Keywords
MBCT, Nonverbal autism, low verbal autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ABA design
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBCT treatment
Arm Type
Experimental
Arm Description
Melodic-based communication treatment
Intervention Type
Behavioral
Intervention Name(s)
Melodic-based Communication Therapy
Intervention Description
General procedures involved in (M.B.C.T.) are as follows: 25 common first words are selected as the targets (e.g., apple, ball, car, dog, cat, eat, go, etc.). Pictures and objects will be used as stimulus items. The top 3-5 incentives as identified by parent survey will be given according to the therapies specific reinforcement schedule. All treatment and evaluation sessions will be videotaped for future/further analysis and verification purposes. For the purposes of the study design, the same 25 words will be used for all participants.
Participants will first listen to the target word set to a melodic tone and rhythm on a compact disc (CD). Clinicians will present the stimulus item (e.g., apple) prior to beginning the steps. Therapy will then progress from clapping and singing the melody to answering sung questions and finally to answering spoken questions with the target word
Primary Outcome Measure Information:
Title
Number of spoken words
Description
Pre/post measures include: number of words reported in home environment by parent pre-vs. post, CASL-2 Pragmatic Language raw score pre-vs. post, number of imitative attempts pre-vs. post, number of words correct in response to the question, "what is this?" and number of vocalizations in response to the question, "what is this?"
Time Frame
4 weeks
Title
Frequency of repetitive and stereotypical behaviors
Description
Frequency of repetitive or stereotypic movements will be analyzed in the first week of treatment (stimming behavior). This will be evaluated as follows: onset/offset and duration of the behaviors to determine frequency. This will be evaluated by an independent observer through video analysis.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female children with autism ages 3-years-0-months to 10-years-11-month who meet the criterion for nonverbal (defined as less than 10 words ever spoken expressively and no functional verbal communication)
Exclusion Criteria:
Individuals receiving other language or articulation treatments or therapy at the time of the study, unable to regularly attend four 30 min sessions of therapy weekly for 4 weeks, a history of severe hearing impairment, severe visual impairment/ blindness, a diagnosis of an organic impairment of oral or laryngeal structures, or a significant medical illness or condition which would prevent the child's participation in the treatment procedures. These conditions include, but are not limited to cerebral palsy, paraplegia, spina bifida, uncontrolled seizures, dysarthria, and amputation of arm(s).
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism
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