Clinical trial NCT04679974: Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism
Official title: Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism Ages: 3:0 - 10:11
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonverbal and Low Verbal Autism
Keywords: MBCT
Nonverbal autism
low verbal autism
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ABA design
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of spoken words
timeFrame: 4 weeks
measure: Frequency of repetitive and stereotypical behaviors
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
References: