MBCT: Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT04679974
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Melodic-based Communication Therapy
N/A

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.

  1. Subjects will be male and female children diagnosed with autism.

  2. Subjects will be between 3 years 0 months and 10 years 11 months of age.

  3. In total, subject participation will last approximately 4 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
ABA designABA design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism Ages: 3:0 - 10:11
Actual Study Start Date :
Jun 17, 2018
Actual Primary Completion Date :
Aug 16, 2018
Actual Study Completion Date :
Aug 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: MBCT treatment

Melodic-based communication treatment

Behavioral: Melodic-based Communication Therapy
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

Outcome Measures

Primary Outcome Measures

  1. Number of spoken words [4 weeks]

    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?"

  2. Frequency of repetitive and stereotypical behaviors [4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Loma Linda California United States 92350

Sponsors and Collaborators

  • Loma Linda University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karen Mainess, Assistant Professor, Loma Linda University
ClinicalTrials.gov Identifier:
NCT04679974
Other Study ID Numbers:
  • 5170235
First Posted:
Dec 22, 2020
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karen Mainess, Assistant Professor, Loma Linda University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2020