Autism Spectrum DisorderNCT03560297
SeRenade Parent-Child Music Class Program
A study testing SeRenade Parent-Child Music Class and Delayed Intervention in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being. Read more about this study
- Who is it for?
- Ages 20 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SeRenade Parent-Child Music Class and Delayed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children diagnosed with ASD or children without ASD
Who cannot join
- currently enrolled in music therapy or parent-child music classes (for children with ASD); significant behavior problems (e.g., aggression toward other children); significant hearing or visual impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD
This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being.
Read the detailed description
This pilot study evaluates the impact of the SeRenade Parent-Child Music Class Program on families of children with and without autism spectrum disorders (ASD). This study examines the impact of this program on social development in children with ASD, parental stress and efficacy, and parent-child relationships. A primary goal of this study is to examine multiple levels of analysis including families' experience within and outside of the music class program.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SeRenade Parent-Child Music Class, Delayed Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeRenade Parent-Child Music ClassBehavioural
Parent-Child Music Class involving parent training, peer inclusion, and musical play
Delayed InterventionBehavioural
Participants receive intervention after delay
| Study group | Role | What they receive |
|---|---|---|
| SeRenade Program | Experimental | Parent-Child Music Class Program (parent training, peer inclusion, musical play) Receives: Behavioral: SeRenade Parent-Child Music Class |
| Delayed/Waitlist Program | Experimental | Participants do not participate in the program for a time period Receives: Behavioral: Delayed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Imitation Scale
Standardized elicited imitation assessment; scores range 0-32; greater scores indicate greater imitation skills
Measured: Change from pre to post program (baseline and 12-weeks)
Actions & Gestures
Standardized parent report questionnaire of child's gestures/actions/pretend play
Measured: Change from pre to post program (baseline and 12-weeks)
Parenting Stress Index, 4th edition Short Form
Standardized parent report questionnaire
Measured: Change from pre to post program (baseline and 12-weeks)
Parenting Efficacy/Quality
Parent report questionnaire; higher scores indicate greater efficacy, range 10-40
Measured: Change from pre to post program (baseline and 12-weeks)
Secondary outcomes (2)
Parent-Child Interaction
parent-child play/music session
Measured: Change from pre to post program (baseline and 12-weeks)
social visual attention eye-tracking paradigm
Measured: Change from pre to post program (baseline and 12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start15 May 2018
- Primary completion23 Dec 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Principal investigator, Miriam Lense, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560297
- Sponsor's protocol ID
- 160784
- Status last verified
- Feb 2022
- First submitted
- 21 May 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data and codebooks will be available to researchers upon request.
Publications
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.
PubMed 35532041
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD
- ClinicalTrials.gov ID
- NCT03560297
- Acronym / sponsor ID
- 160784
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- 15 May 2018 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being.
Detailed description
This pilot study evaluates the impact of the SeRenade Parent-Child Music Class Program on families of children with and without autism spectrum disorders (ASD). This study examines the impact of this program on social development in children with ASD, parental stress and efficacy, and parent-child relationships. A primary goal of this study is to examine multiple levels of analysis including families' experience within and outside of the music class program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeRenade Program | Experimental | Behavioral: SeRenade Parent-Child Music ClassParent-Child Music Class Program (parent training, peer inclusion, musical play) |
| Delayed/Waitlist Program | Experimental | Behavioral: Delayed InterventionParticipants do not participate in the program for a time period |
Who may qualify
- Ages
- 20 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children diagnosed with ASD or children without ASD
Key exclusion criteria (1 listed)
- currently enrolled in music therapy or parent-child music classes (for children with ASD); significant behavior problems (e.g., aggression toward other children); significant hearing or visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeRenade Parent-Child Music ClassParent-Child Music Class involving parent training, peer inclusion, and musical play | Behavioural | SeRenade Program |
| Delayed InterventionParticipants receive intervention after delay | Behavioural | Delayed/Waitlist Program |
Primary outcome
Motor Imitation Scale
Time frame: Change from pre to post program (baseline and 12-weeks)
Standardized elicited imitation assessment; scores range 0-32; greater scores indicate greater imitation skills
Actions & Gestures
Time frame: Change from pre to post program (baseline and 12-weeks)
Standardized parent report questionnaire of child's gestures/actions/pretend play
Parenting Stress Index, 4th edition Short Form
Time frame: Change from pre to post program (baseline and 12-weeks)
Standardized parent report questionnaire
Parenting Efficacy/Quality
Time frame: Change from pre to post program (baseline and 12-weeks)
Parent report questionnaire; higher scores indicate greater efficacy, range 10-40
2 secondary outcomes
Parent-Child Interaction
Time frame: Change from pre to post program (baseline and 12-weeks)
social visual attention eye-tracking paradigm
Time frame: Change from pre to post program (baseline and 12-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 35532041Geretsegger 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.
- Individual participant dataSharing planned: Undecided. Deidentified data and codebooks will be available to researchers upon request.
Related trials for Autism Spectrum Disorder
Recruiting
A Comparative Study of Driving Performance Among Adolescents With Autism Spectrum Disorder and Neurotypical Adolescents
Autism Spectrum Disorders
Not yet recruiting
Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder
Autism Spectrum Disorder, TMS
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeRenade Parent-Child Music Class and Delayed Intervention in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Imitation Scale (time frame: Change from pre to post program (baseline and 12-weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.