Music Training for Fetal Alcohol Spectrum Disorders (Synchrony Trial)

N/A

Recruiting

Research Sponsored by The Mind Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if music training can help children with fetal alcohol spectrum disorder (FASD) improve their behavior and cognitive abilities. Participants will either practice piano daily or listen to music daily for

Who is the study for?

This trial is for children who have been exposed to alcohol before birth and have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). They should be able to participate in daily music activities for 12 weeks.

What is being tested?

The study tests if piano training or listening to music can help improve behavior and brain functions like attention and memory in kids with FASD. Each child will do both activities, one after the other, for 12 weeks each, with their order chosen randomly.

What are the potential side effects?

Since this trial involves non-medical interventions such as piano playing and music listening, there are no expected side effects related to medication. However, participants may experience fatigue or frustration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Attention using the Conners Continuous Performance Test

Assessment of Working Memory using Wechsler Intelligence Scale for Children (WISC V)

Assessment of behavioral regulation - Inhibit

Secondary study objectives

Assessment of cognitive flexibility

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Piano training then music listeningExperimental Treatment2 Interventions

Participants will practice piano for 10 minutes per day for 12 weeks. After one week of assessments, participants will listen to music for 10 minutes per day for 12 weeks.

Group II: Music listening then piano trainingExperimental Treatment2 Interventions

Participants will listen to music for 10 minutes per day for 12 weeks. After one week of assessments, participants will practice piano for 10 minutes per day for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Music listening

2023

N/A

~900

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