Clinical trial NCT05406076: the Efficacy of Oral Motor Therapy in Children With Autism
Official title: A Multicenter Randomized Controlled Study of the Efficacy of Oral Motor Therapy in Children With Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Hefei Kanghua Rehabilitation Hospital
name: Hefei Jingu Rehabilitation Hospital
First posted: 2022-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children with Autism spectrum disorders have speech disorders, which in turn aggravate communication difficulties and lead to an increase in their core symptoms. This experiment attempts to investigate the efficacy of Chinese language oral motor therapy in improving various aspects of articulation, language ability, and behavior of children with autism in conjunction with the International General Autism Scale, and provides a basis for the rational formulation of clinical treatment plans.

Detailed description: Oral Motor Therapy (OMT) is a treatment process that uses tactile and proprioceptive stimulation techniques to promote the normalization of the sensory perception of the mouth (jaw, lips, tongue), suppress abnormal mouth movement patterns, and establish normal mouth movement patterns, following the principles of motor skill development.

This study investigates the efficacy of Chinese language oral motor therapy on improving various aspects of articulation, language ability, and behavior of children with autism. The study is divided into two parts, each eight weeks long. Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups: the experimental group and the control group, in a 1:1 ratio. The experimental group was treated with 2 months of ABA+oral motor therapy followed by 2 months of ABA therapy; the control group was treated with 2 months of ABA therapy followed by 2 months of ABA+oral motor therapy.

Each subject underwent ABC, CARS, S-S, VB-MAPP, and ABLLS-R assessments before enrollment, 2 months after enrollment, and after discharge from the group.

Eligibility criteria: Inclusion Criteria:

1. Children who meet the DSM-V diagnosis of autism.
2. Age 2-5 years old, regardless of gender.
3. Native Chinese language.
4. No prior oral motor therapy.
5. Family members voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

1. Children with co-occurring epilepsy.
2. Children with comorbid other psychiatric disorders.
3. Children with severe hearing impairment, history of visual impairment/blindness, organic disease of the mouth/throat, or significant medical illness or condition that prevents the child from participating in treatment procedures.
4. Children who received other oral motor training or speech articulation therapy during the intervention period.
5. Those who could not perform the intervention as planned after participating in the experiment.
6. Those deemed unsuitable by the investigator to participate in this experiment.

Primary outcomes:
measure: Changes in the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) scores
timeFrame: Baseline (week 0), Week 8，Week 16
measure: Changes in Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) scores
timeFrame: Baseline (week 0), Week 8，Week 16
measure: Change in the Autism Behavior Scale (ABC) scores
timeFrame: Baseline (week 0), Week 8，Week 16
measure: Change in Childhood Autism Rating Scale (CARS) scores
timeFrame: Baseline (week 0), Week 8，Week 16
measure: Change in China Rehabilitation Research Center version of the Sign-Significance（S-S，CRRC version） scores
timeFrame: Baseline (week 0), Week 8，Week 16
Secondary outcomes:
Other outcomes:
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