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Completed

NCT Number: NCT04679974

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

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

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.

  • Subjects will be male and female children diagnosed with autism.
  • Subjects will be between 3 years 0 months and 10 years 11 months of age.
  • In total, subject participation will last approximately 4 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Melodic-based Communication Therapy

Behavioral

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 outcomes

  1. Number of spoken words

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism Ages: 3:0 - 10:11

Acronym: MBCT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.