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the Efficacy of Oral Motor Therapy in Children With Autism

Primary Purpose

Autism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral motor therapy
ABA
Sponsored by
The First Affiliated Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Oral Motor Therapy/ABA

    ABA/Oral Motor Therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) scores
    VB-MAPP is a criterion-referenced language and academic proficiency assessment system, curriculum instruction and skill tracking system for children with autism and speech and language delays. It is used for children 0-48 months of age. It has five components: milestone assessment, impairment assessment, transition assessment, task analysis, and supportive competencies and goals for placement and individualized education program (IEP).
    Changes in Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) scores
    The ABLLS-R is for children ages 0-12. The scale has 25 major assessment items and 544 skill subtests that help children with autism learn the skills they need to communicate effectively and daily; and it can track the learning of each skill, which means that multiple assessments can be made, with the later assessment building on the previous one, giving this autism assessment tool a curriculum guide role.
    Change in the Autism Behavior Scale (ABC) scores
    The ABC scale is widely used in the assessment of autism conditions and the evaluation of treatment outcomes, and is one of the most commonly used autism assessment scales. It is used for screening of autistic individuals aged 18 months to 35 years. The scale is assessed by the child's parents or someone with whom the child has lived for at least 2 weeks and takes approximately 10-15 minutes to assess.
    Change in Childhood Autism Rating Scale (CARS) scores
    CARS is an observation tool used by clinicians for speech, behavior, and sensory perception in children with autism.
    Change in China Rehabilitation Research Center version of the Sign-Significance(S-S,CRRC version) scores
    The S-S detects the gap between the level of language delay and the actual age, as well as the status of the language delay, and is suitable for children aged 1-6.5 years with language delay. The test is administered individually and takes approximately 40 minutes to complete.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2022
    Last Updated
    October 25, 2022
    Sponsor
    The First Affiliated Hospital of Anhui Medical University
    Collaborators
    Hefei Kanghua Rehabilitation Hospital, Hefei Jingu Rehabilitation Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05406076
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Anhui Medical University
    Collaborators
    Hefei Kanghua Rehabilitation Hospital, Hefei Jingu Rehabilitation Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral Motor Therapy/ABA
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    ABA/Oral Motor Therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    oral motor therapy
    Intervention Description
    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
    Intervention Name(s)
    ABA
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in the Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) scores
    Description
    VB-MAPP is a criterion-referenced language and academic proficiency assessment system, curriculum instruction and skill tracking system for children with autism and speech and language delays. It is used for children 0-48 months of age. It has five components: milestone assessment, impairment assessment, transition assessment, task analysis, and supportive competencies and goals for placement and individualized education program (IEP).
    Time Frame
    Baseline (week 0), Week 8,Week 16
    Title
    Changes in Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) scores
    Description
    The ABLLS-R is for children ages 0-12. The scale has 25 major assessment items and 544 skill subtests that help children with autism learn the skills they need to communicate effectively and daily; and it can track the learning of each skill, which means that multiple assessments can be made, with the later assessment building on the previous one, giving this autism assessment tool a curriculum guide role.
    Time Frame
    Baseline (week 0), Week 8,Week 16
    Title
    Change in the Autism Behavior Scale (ABC) scores
    Description
    The ABC scale is widely used in the assessment of autism conditions and the evaluation of treatment outcomes, and is one of the most commonly used autism assessment scales. It is used for screening of autistic individuals aged 18 months to 35 years. The scale is assessed by the child's parents or someone with whom the child has lived for at least 2 weeks and takes approximately 10-15 minutes to assess.
    Time Frame
    Baseline (week 0), Week 8,Week 16
    Title
    Change in Childhood Autism Rating Scale (CARS) scores
    Description
    CARS is an observation tool used by clinicians for speech, behavior, and sensory perception in children with autism.
    Time Frame
    Baseline (week 0), Week 8,Week 16
    Title
    Change in China Rehabilitation Research Center version of the Sign-Significance(S-S,CRRC version) scores
    Description
    The S-S detects the gap between the level of language delay and the actual age, as well as the status of the language delay, and is suitable for children aged 1-6.5 years with language delay. The test is administered individually and takes approximately 40 minutes to complete.
    Time Frame
    Baseline (week 0), Week 8,Week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children who meet the DSM-V diagnosis of autism. Age 2-5 years old, regardless of gender. Native Chinese language. No prior oral motor therapy. Family members voluntarily participated in this study and signed an informed consent form. Exclusion Criteria: Children with co-occurring epilepsy. Children with comorbid other psychiatric disorders. 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. Children who received other oral motor training or speech articulation therapy during the intervention period. Those who could not perform the intervention as planned after participating in the experiment. Those deemed unsuitable by the investigator to participate in this experiment.

    12. IPD Sharing Statement

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    the Efficacy of Oral Motor Therapy in Children With Autism

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