the Efficacy of Oral Motor Therapy in Children With Autism

NCT ID: NCT05406076

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-08-01

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.

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Motor Therapy/ABA

Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups according to a 1:1 ratio. The experimental group was first treated with 2 months of ABA + oral motor therapy, followed by 2 months of ABA treatment.

Oral motor therapy appliances can be used during mouth muscle training sessions, depending on the individual needs of the child. 30-40 min/session, 1 session/day, 5 sessions/week.

ABA training time is at least 20 hours per week. The therapist is fully aware of each stage of the child's training during the teaching process and can make an accurate assessment of the child.

Group Type: ACTIVE_COMPARATOR

oral motor therapy

Intervention Type: BEHAVIORAL

Rigorous Chinese language oral motor therapy, including treatment of oral perceptual disorders and treatment of oral motor disorders. The treatment follows three basic principles: a combination of basic training and specific treatment; a combination of self-help and assisted treatment; and a combination of exercises, cues, and stimulation techniques. 30-40 min/session, 1 session/day, 5 sessions/week.

ABA

Intervention Type: BEHAVIORAL

The mainstream ASD intervention approach with evidence-based support is currently recognized worldwide. Treatment follows the operational core principles of ABA, which are to establish learning goals based on the child's ability level, design teaching situations and select reinforcers for them, change the child's behavior problems with operational constraints, and to eliminate or improve problem behaviors through appropriate interventions to shape new adaptive behaviors. The training time is at least 20 hours per week.

ABA/Oral Motor Therapy

Eighty subjects who met the inclusion/exclusion criteria were randomly divided into 2 groups according to a 1:1 ratio. The control group was treated with 2 months of ABA followed by 2 months of ABA + oral motor therapy.

Oral motor therapy appliances can be used during mouth muscle training sessions, depending on the individual needs of the child. 30-40 min/session, 1 session/day, 5 sessions/week.

ABA training time is at least 20 hours per week. The therapist is fully aware of each stage of the child's training during the teaching process and can make an accurate assessment of the child.

Group Type: ACTIVE_COMPARATOR

oral motor therapy

Intervention Type: BEHAVIORAL

Rigorous Chinese language oral motor therapy, including treatment of oral perceptual disorders and treatment of oral motor disorders. The treatment follows three basic principles: a combination of basic training and specific treatment; a combination of self-help and assisted treatment; and a combination of exercises, cues, and stimulation techniques. 30-40 min/session, 1 session/day, 5 sessions/week.

ABA

Intervention Type: BEHAVIORAL

The mainstream ASD intervention approach with evidence-based support is currently recognized worldwide. Treatment follows the operational core principles of ABA, which are to establish learning goals based on the child's ability level, design teaching situations and select reinforcers for them, change the child's behavior problems with operational constraints, and to eliminate or improve problem behaviors through appropriate interventions to shape new adaptive behaviors. The training time is at least 20 hours per week.

Interventions

oral motor therapy

Rigorous Chinese language oral motor therapy, including treatment of oral perceptual disorders and treatment of oral motor disorders. The treatment follows three basic principles: a combination of basic training and specific treatment; a combination of self-help and assisted treatment; and a combination of exercises, cues, and stimulation techniques. 30-40 min/session, 1 session/day, 5 sessions/week.

Intervention Type: BEHAVIORAL

ABA

The mainstream ASD intervention approach with evidence-based support is currently recognized worldwide. Treatment follows the operational core principles of ABA, which are to establish learning goals based on the child's ability level, design teaching situations and select reinforcers for them, change the child's behavior problems with operational constraints, and to eliminate or improve problem behaviors through appropriate interventions to shape new adaptive behaviors. The training time is at least 20 hours per week.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hefei Kanghua Rehabilitation Hospital

UNKNOWN

Sponsor Role: collaborator

Hefei Jingu Rehabilitation Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

WDX-05

Identifier Type: -

Identifier Source: org_study_id