The Synchrony Study: Examining Music Training for Children With FASD

NCT06005181 | Recruiting

• 1 other identifier: 23-052
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine if music training improves behavioral or cognitive performance in children with prenatal alcohol exposure who meet research criteria for a fetal alcohol spectrum disorder. The main questions it aims to answer are:

• Does music training improve behavioral regulation for children with an FASD
• Does music training improve cognitive performance (attention and working memory) for children with an FASD. The study has two interventions for each participant: music listening and piano training. Each participant will either practice piano daily for 12 weeks or listen to pre-selected music daily for 12 weeks. The order of the interventions will be randomized across participants. Assessment will occur before and after participation in each 12 week intervention.

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

music training; music listening; piano training; attention

Outcome Measures

Primary Outcomes (3)

• Assessment of behavioral regulation - Inhibit

  The inhibit subscale from the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF 2) Inhibit subscale; min/max: t score: 35 - \>90; higher score means more impairment

  12 weeks

• Assessment of Attention using the Conners Continuous Performance Test

  Examine change in sustained attention based on the Conners Continuous Performance Test - Third Edition (CPT 3): Omission subscale; min/max: t score: \<40 - \>90; higher score means more impairment

  12 weeks

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

  Wechsler Intelligence Scale for Children - Fifth Edition (WISC V): Digit Span Backwards subtest, min/max: scaled score: 1 - 19; higher score means better performance.

  12 weeks

Secondary Outcomes (1)

• Assessment of cognitive flexibility

  12 weeks

Study Arms (2)

Music listening then piano training

EXPERIMENTAL

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.

Behavioral: Music listening; Behavioral: Piano training

Piano training then music listening

EXPERIMENTAL

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.

Behavioral: Music listening; Behavioral: Piano training

Interventions

Music listening BEHAVIORAL

Daily music listening

Music listening then piano training; Piano training then music listening

Piano training BEHAVIORAL

Daily piano practice

Music listening then piano training; Piano training then music listening

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children must receive a research designation of FASD
• Children must have confirmed prenatal alcohol exposure

You may not qualify if:

• Children with other confirmed developmental disorders that are not deemed associated with FASD (e.g. autism spectrum disorder, Down Syndrome). Children with attention deficits (e.g. ADHD) are not excluded.
• Children with neurological disorders (epilepsy, cerebral palsy, etc.)
• Children who have experienced a traumatic brain injury with loss of consciousness \>10 minutes
• Children with intelligence quotient scores \<70
• Children who are, or become, a ward of the state; however children with a legal representative who can consent on their behalf will not be excluded
• Children with ongoing music training outside of school or \>1 year of prior private music lessons.

Sponsors & Collaborators

• The Mind Research Network: lead
• University of New Mexico: collaborator

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

RECRUITING

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Julia M Stephen, PhD

CONTACT

505-272-5028; JSTEPHEN@MRN.ORG

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Parents/participants will be masked to which condition is active/passive. The outcomes assessor will be masked to condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This randomized cross-over design will employ two arms: music listening and piano training. Participants and outcomes assessor will be masked to which arm is active/passive.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: October 2, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon completion of the study
• Access Criteria: NIAAA-DA data sharing guidelines

Locations

US (1)