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Music for Autism (M4A) (M4A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04936048
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborators:
University of Bergen
University of Vienna
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

Brief Summary:
The Music for Autism (M4A) trial evaluates the neurobehavioral outcomes of a music therapy (MT) intervention, compared to a matched play therapy (PT) intervention, on social communication skills, brain connectivity and structural brain changes. In a crossover randomised controlled trial (RCT), 80 children with autism across all levels of functioning, aged 6-12 years, undergo a baseline assessment, which includes measurements of social communication, participation, functional connectivity and brain structure. Participants are then randomly allocated to a sequence of interventions (MT-PT or PT-MT) and assessments are taken before and after each intervention period. Both interventions will target common goals and follow the same structure, while at the same time allowing for flexibility in the therapists' approach. It is hypothesized that 12 weeks of intervention through MT, compared to PT, will improve social communication skills, participation, and other relevant mental health outcomes in children with autism spectrum disorder (ASD), as well as regulate resting-state functional over and under-connectivity and increase grey and white matter volume in specified regions. The investigators also expect changes in functional brain connectivity to correlate with behavioural outcome measures, specifically with improved social communication skills.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Behavioral: Music Therapy Behavioral: Play therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: M4A is designed as an assessor blinded crossover RCT, comparing music therapy (MT) to a structurally matched play therapy (PT) intervention. Following the baseline assessment, a concealed random allocation to a sequence of interventions (MT-PT or PT-MT) will be implemented by one researcher who does not have contact with participants. Each intervention has a duration of 3 months and includes a 3 month washout period between interventions. Baseline assessments will be conducted before each intervention period.
Masking: Single (Outcomes Assessor)
Masking Description: To ensure blinding, the primary outcome measure will be completed by special educators who are familiar with the child (rather than their parents). Success of blinding (for all outcomes) will be verified at the last follow-up.
Primary Purpose: Treatment
Official Title: Music for Autism: Binational Randomised Controlled Trial of Music Therapy Versus Play Therapy for Autistic Children
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Music therapy/Play therapy

This sequence of interventions begins with 12 weeks of music therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of play therapy intervention.

Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, and interaction. In both interventions, children can choose 4 activities per session using a visual schedule.

Behavioral: Music Therapy
Music therapy will use rhythmic cues, music instruments (piano, drums, djembe, xylophone, harmonica), songs, and stories accompanied by songs or musical instruments to target common goals.

Behavioral: Play therapy
Play therapy is designed as a play-based active comparison condition to control for factors such as support, therapist attention, positive expectancies, and emotional engagement. It will use verbal interaction, toys (Lego, finger puppets, Play Doh, puzzles), and the same stories as in MT, but without a musical component, to target common goals.

Active Comparator: Play therapy/Music therapy

This sequence of interventions begins with 12 weeks of play therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of music therapy intervention.

Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, interaction. In both interventions, children can choose 4 activities per session using a visual schedule.

Behavioral: Music Therapy
Music therapy will use rhythmic cues, music instruments (piano, drums, djembe, xylophone, harmonica), songs, and stories accompanied by songs or musical instruments to target common goals.

Behavioral: Play therapy
Play therapy is designed as a play-based active comparison condition to control for factors such as support, therapist attention, positive expectancies, and emotional engagement. It will use verbal interaction, toys (Lego, finger puppets, Play Doh, puzzles), and the same stories as in MT, but without a musical component, to target common goals.




Primary Outcome Measures :
  1. Children's Communication Checklist-2 [ Time Frame: 12 weeks ]

    The Children's Communication Checklist-2 is a measure designed to assess the communication skills of children. The caregiver-report scale measures aspects of pragmatic communication with 70 items across 10 subdomains.

    The standard general communication composite standard score will be used as a measure of a child's general pragmatics and communication ability.

    Scores on the general composite of the Children's Communication Checklist-2 have a mean of 100 (SD=15). Higher scores indicate better social-communication skills.


  2. Brain connectivity of frontotemporal regions [ Time Frame: 12 weeks ]
    Brain connectivity of frontotemporal regions will be measured as resting state functional connectivity (rsFC) from 6 seeds, will be used as the main neuroscientific outcome. Seeds will be anatomically defined regions of interest (ROIs) in Montreal Neurological Institute space for the left and right Heschl's gyrus, inferior frontal gyrus, and temporal pole.


Secondary Outcome Measures :
  1. Child and Adolescent Scale of Participation [ Time Frame: 12 weeks ]

    The Child and Adolescent Scale of Participation is a caregiver-report scale consisting of 20 ordinal-scaled items across four subdomains (home participation, community participation, school participation, home and community living activities), that assesses participation. The 20 items are rated on a four-point scale: 1=Unable to participate, 2=Very limited, 3=Somewhat limited, 4=Age expected / Full participation.

    Higher scores mean a better outcome, indicating more participation in general. Minimum-maximum total scores: 25-100.


  2. Beach Center Family Quality of Life Scale [ Time Frame: 12 weeks ]

    The 25 item scale is used to measure several aspects of families' perceived satisfaction in terms of quality of family life under five domains: Family Interaction, Parenting, Emotional Well-being, Physical / Material Well-being, and Disability-Related Support.

    The scale uses satisfaction as the primary response format. Participants are asked to rate their levels of satisfaction with certain statements on a 5-point scale, where 1 = very dissatisfied, 3 = neither satisfied nor dissatisfied, and 5 = very satisfied. Higher scores mean a better outcome as they indicate more satisfaction with the families' quality of life. Minimum-maximum total scores: 25-125.


  3. Peabody Picture Vocabulary Test- 4th edition [ Time Frame: 12 weeks ]

    The Peabody Picture Vocabulary Test- 4th edition is a measure used to assess receptive (hearing) vocabulary through 228 items (each with a spoken word + 4 pictures).

    Raw scores are calculated, then converted to standard score equivalents using tables from the manual. The converted scores have a mean of 100 and a standard deviation of 15. Scores from 70 to 85 are considered moderately low, and scores less than 70 are extremely low. Scores from 85 to 115 are considered average. Scores from 115 to 130 are considered moderately high and scores greater than 130 are extremely high. Higher scores indicate better receptive vocabulary.


  4. Social Responsiveness Scale [ Time Frame: 12 weeks ]

    Symptom severity will be assessed through the Social Responsiveness Scale, a 65-item rating scale measuring deficits in social behavior associated with autism.

    Caregivers rate on a 4-point Likert scale how often a statement has described a child's behavior over the past six months (1=not true to 4=almost always true).

    Adding all items generates a total score, with higher scores indicating greater severity of social difficulties and other behaviors associated with autism spectrum disorder.

    Additionally, the Social Responsiveness Scale yields five subscales: social awareness, social communication, social motivation, social cognition, and restricted and repetitive behaviors. Adding the items within each subscale yields a total score for each construct.

    Minimum- Maximum total score: 65-195.


  5. Vineland Adaptive Behavior Scales [ Time Frame: 12 weeks ]

    The Vineland Adaptive Behavior Scales is a standardized assessment tool that utilizes semi-structured interview to measure adaptive behavior and support the diagnosis of intellectual and developmental disabilities, autism, and developmental delays.

    The maladaptive behaviours subdomain of the scale is used to identify the presence of behavior problems such as challenging internalizing and externalizing behaviours in children up to age 18. The scale is administered as a semi-structured interview to an informant who knows the child well. VABS v-scale scores have a mean of 15, (SD=3). Three categories are used to convey the degree of maladaptive behaviour in an individual corresponding to v-scale scores- Below 18: Average, 18-20: Elevated, 21-24: Clinically significant.


  6. Hair cortisol concentration [ Time Frame: 12 weeks ]
    Chronic stress will be measured through hair cortisol concentration in the scalp-nearest 3cm segment, reflecting cumulative cortisol secretion over the past 3 months.

  7. Grey and white matter volume (Structural brain changes) [ Time Frame: 12 weeks ]
    Changes in grey and white matter volume will be assessed in a whole-brain scan using voxel-based morphometry (VBM), derived from the anatomical T1 image, acquired at the beginning of each fMRI scan. ROIs include the 6 seedS: left and right Heschl's gyrus, inferior frontal gyrus, and temporal pole), as well as cerebellum, superior temporal sulcus, and temporo-parietal area.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet diagnostic criteria as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-V) and officially diagnosed with autism spectrum disorder (ASD) by a licensed clinical professional using standardised diagnostic tools (Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview Revised (ADI-R)).

Exclusion Criteria:

  • Recent or current music therapy
  • Metallic or electronic implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04936048


Contacts
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Contact: Christian Gold, PhD +47-97501757 chgo@norceresearch.no
Contact: Marianna Ruiz, MSc +4756107313 maru@norceresearch.no

Locations
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Austria
University of Vienna Recruiting
Vienna, Austria
Contact: Alexander Groessing       M4A.psychologie@univie.ac.at   
Contact: Giorgia Silani, PhD       giorgia.silani@univie.ac.at   
Norway
NORCE Norwegian Research Centre Recruiting
Bergen, Norway
Contact: Marianna Ruiz       maru@norceresearch.no   
Contact: Christian Gold, PhD       chgo@norceresearch.no   
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
University of Bergen
University of Vienna
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Responsible Party: NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT04936048    
Other Study ID Numbers: M4A
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

De-identified clinical and neuroimaging data will be made accessible for re-use by other researchers via platforms such as ENIGMA.

We also plan to publish the primary outcome IPD on a public repository such as NSD (www.nsd.no).

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Permanent, from the date of publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NORCE Norwegian Research Centre AS:
crossover randomised controlled trial
music therapy
autism spectrum disorder
functional connectivity
functional magnetic resonance imaging (fMRI)
social communication
grey and white matter
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders