Effectiveness of Music Therapy in Social Skill Intervention for Children With ASD/ID

NCT04557488 | Completed

• 1 other identifier: FHB/H/41/165
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Autism spectrum disorder (ASD) is a developmental impairment characterized by persistent deficits in social communication and interactions. The prevalence figures have increased rapidly in recent years due to the expansion of diagnostic criteria and increased public awareness. The clinical presentations of ASD vary to a large extent, and approximately 56% of children with ASD possess below average intellectual ability (IQ \< 85). The intellectual, verbal, and social ability in this population may greatly influence intervention outcomes. The social development of children with ASD and comorbid intellectual disability (ID) is not well understood, and how children with ASD/ID respond to social skill interventions remains to be investigated. Musical elements are a part of various behavioral interventions for ASD, however, the effects of music as interventions for ASD individuals have not been comprehensively examined in Hong Kong. The proposed study will address limited research evidence on music therapy as an intervention for social functioning in children with ASD with mild to borderline ID. Music therapy is a systematic process of intervention, wherein a therapist helps clients promote their health by using musical experience and relationships that develop through them. In particular, the investigators will examine whether using music therapy in social skill intervention provides additional benefits relative to non-musical intervention in a 12-week randomized controlled trial. Pre-treatment neural response of electroencephalograms (EEG) to social scenes will be used to predict the outcomes of social skill interventions, whereas EEG responses to music will be used to predict the effectiveness of musical social skill intervention. If correlation is found, then the long-term goal is to develop individualized intervention based on pre-treatment markers to maximize treatment efficacy. Aims and hypotheses:

1. 1.Is social skill intervention using music therapy more effective in enhancing social interaction than non-musical social skill training for children with ASD and co-occurring mild/borderline ID?
2. 2.Participants with enhanced neural response to social scenes relative to baseline would be more responsive to social skill interventions.
3. 3.Participants with enhanced neural response to preferred music relative to baseline would be more responsive to music therapy targeting social skill intervention.

Conditions

Autism Spectrum Disorder; Intellectual Disability

Outcome Measures

Primary Outcomes (8)

• Changes of Childhood Autism Rating Scale-2

  This scale consists of 15 questions rating the autistic symptoms and general impression of deviance based on behavioral observations. Each question is rated from 1 to 4, and high scores are associated with a high level of impairment. Scores below 30 indicate that an individual does not have ASD, scores between 30 and 36.5 imply mild to moderate autism, and scores from 37 to 60 correspond to severe autism.

  Pre-test 2 weeks before Day 1

• Changes of Childhood Autism Rating Scale-2

  This scale consists of 15 questions rating the autistic symptoms and general impression of deviance based on behavioral observations. Each question is rated from 1 to 4, and high scores are associated with a high level of impairment. Scores below 30 indicate that an individual does not have ASD, scores between 30 and 36.5 imply mild to moderate autism, and scores from 37 to 60 correspond to severe autism.

  2 weeks after intervention

• Changes of Childhood Autism Rating Scale-2

  This scale consists of 15 questions rating the autistic symptoms and general impression of deviance based on behavioral observations. Each question is rated from 1 to 4, and high scores are associated with a high level of impairment. Scores below 30 indicate that an individual does not have ASD, scores between 30 and 36.5 imply mild to moderate autism, and scores from 37 to 60 correspond to severe autism.

  4 months after intervention

• Changes of Social Responsiveness Scale second edition

  The scale is a 65-item questionnaire that measures the severity of social impairments associated with ASD. The five subscales include social awareness, social cognition, social motivation, social communication, and autistic mannerisms. Each item is rated on a scale from "0" (never true) to "3" (almost always true), and high scores indicate severe social impairments.

  Pre-test 2 weeks before Day 1

• Changes of Social Responsiveness Scale second edition

  The scale is a 65-item questionnaire that measures the severity of social impairments associated with ASD. The five subscales include social awareness, social cognition, social motivation, social communication, and autistic mannerisms. Each item is rated on a scale from "0" (never true) to "3" (almost always true), and high scores indicate severe social impairments.

  2 weeks after intervention

• Changes of Social Responsiveness Scale second edition

  The scale is a 65-item questionnaire that measures the severity of social impairments associated with ASD. The five subscales include social awareness, social cognition, social motivation, social communication, and autistic mannerisms. Each item is rated on a scale from "0" (never true) to "3" (almost always true), and high scores indicate severe social impairments.

  4 months after intervention

• In-session social behavior

  The intervention sessions in the treatment and control groups will be videotaped using a high-resolution video camera, and data from the first and last sessions will be coded for target social behavior.

  Day 1

• In-session social behavior

  The intervention sessions in the treatment and control groups will be videotaped using a high-resolution video camera, and data from the first and last sessions will be coded for target social behavior.

  Last intervention session, approximately 12 weeks after Day 1.

Secondary Outcomes (3)

• Changes of EEG recording

  2 weeks before Day 1

• Changes of EEG recording

  2 weeks after intervention

• Changes of EEG recording

  4 months after intervention

Study Arms (2)

Music therapy

EXPERIMENTAL

The treatment group will receive social skill intervention using music therapy in groups of eight. A certified music therapist with prior experience with children with ASD and ID will be the trainer for the treatment group. Parents or the primary caregivers will be invited to attend the intervention sessions and to observe the training. An assistant trainer will also be present in all sessions to facilitate the group activities, manage unexpected situations, and ensure the safety of the participants.

Other: Music therapy

Behavioral-based social skill training

EXPERIMENTAL

The control group will receive behavioral-based social skill training in groups of eight. The trainer will be a registered social worker with experience in providing social skill training for children with ASD and ID. Parents or the primary caregivers will be invited to attend the intervention sessions and to observe the training. An assistant trainer will also be present in all sessions to provide support.

Behavioral: Behavioral-based social skill training

Interventions

Music therapy OTHER

Each session will follow a similar structure with a hello song, musical activities, and a goodbye song. The musical activities will vary in each session and will be mixed in later sessions to revisit and practice social skills

Music therapy

Behavioral-based social skill training BEHAVIORAL

Each intervention session will follow a standard structure of opening greetings, social activities according to the theme of the session, and a closing activity. The activities and games will vary in each session and will be mixed in later session to revisit and practice social skills.

Also known as: game-based therapy, applied behavioral analysis

Behavioral-based social skill training

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A formal clinical diagnosis of ASD
• An assessed overall and verbal IQ of 50-84 by a certified clinician
• Children who report hypersensitivity to sounds may be included with consent but will be withdrawn immediately if adverse reactions are observed

You may not qualify if:

• Children who exhibit severe physical or sensory disabilities (e.g., deafness) that may limit their participation in either intervention
• Children with other neurodevelopmental, psychiatric, or neurological comorbidities or are on prescribed psychiatric medication will also be excluded from the study

Sponsors & Collaborators

• Education University of Hong Kong: lead

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

• Geretsegger M, Fusar-Poli L, Elefant C, Mossler KA, Vitale G, Gold C. Music therapy for autistic people. Cochrane Database Syst Rev. 2022 May 9;5(5):CD004381. doi: 10.1002/14651858.CD004381.pub4.

  PMID: 35532041 DERIVED

• Yum YN, Lau WK, Poon K, Ho FC. Music therapy as social skill intervention for children with comorbid ASD and ID: study protocol for a randomized controlled trial. BMC Pediatr. 2020 Dec 5;20(1):545. doi: 10.1186/s12887-020-02454-6.

  PMID: 33276744 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 21, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)