Health TrialsbyHealthPanel

The Synchrony Study: Examining Music Training for Children With FASD

ConditionFetal Alcohol Spectrum Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorThe Mind Research Network

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children must receive a research designation of FASD

Children must have confirmed prenatal alcohol exposure

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Music listening

    Behavioral

    Daily music listening

  • Piano training

    Behavioral

    Daily piano practice

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Music listening then piano trainingExperimental treatment 2 interventions
Group B: Piano training then music listeningExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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.

Time frame
12 weeks

Secondary outcomes

1

Assessment of cognitive flexibility

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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Mind Research Network

Lead sponsor

University of New Mexico

Collaborator

Source ClinicalTrials.gov
Apply now