Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06005181 |
Other study ID # |
23-052 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2, 2023 |
Est. completion date |
September 2028 |
Study information
Verified date |
March 2024 |
Source |
The Mind Research Network |
Contact |
Julia M Stephen, PhD |
Phone |
505-272-5028 |
Email |
JSTEPHEN[@]MRN.ORG |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Music training has been shown to alter brain function and structure in musicians relative to
nonmusicians. Music training requires a complex set of skills. By engaging in this activity,
music training may alter brain development in children and increase cortical connectivity
such that it provides improved self-regulation and cognitive performance. However, music
training has not been tested in children with a fetal alcohol spectrum disorder, despite
known behavioral and cognitive effects of prenatal alcohol exposure.
The study will employ a randomized, cross-over design to examine the effects of piano
training versus music listening. Participants will be asked to attend two information
sessions prior to study enrollment. These will provide participants with detailed information
about the study expectations, complete study consent/assent, and train participants on use of
the devices for music listening/piano training. Participants will receive baseline
assessments which include cognitive testing, behavioral questionnaires and neuroimaging. Each
participant will be randomized to receive 12 weeks of either music listening or piano
training. After the initial 12 week intervention is completed, participants will receive an
intermediate assessment where the initial assessment battery will be repeated. The
participants will then engage in the other arm of the study (music listening or piano
training) for an additional 12 weeks. During the last week of the study, the initial
assessment battery will be repeated a third time.
During music listening, the participant will be provided with a device that will allow the
participant to access study-selected music. Participants will be provided with one music
list/week for 12 weeks and will be asked to listen to music from the study-selected music for
at least 10 minutes per day. Participants will be required to check in with the study team
weekly to receive the next week's playlist and to ensure compliance.
During piano training, the participant will be provided with an electronic keyboard that will
allow the participant to practice piano daily. Participants will attend weekly ½ hour piano
lessons which will follow a commercially-available beginner piano curriculum. Participants
will be assigned weekly homework with the requirement of practicing piano at least 10 minutes
per day. Progress will be checked at each weekly piano lesson to ensure compliance.
All data will be either collected directly from the participants using COINS, an online
database and assessment tool, or will be double data entered into COINS with conflicts
resolved through consultation of the source material. Assessments will be transferred to the
National Institute on Alcohol Abuse and Alcoholism data archive (NIAAA-DA), which validates
data entry values relative to expected ranges. Any violations will be corrected within the
COINS database via consultation with source material and re-extracted for data upload to
NIAAA-DA. NIAAA-DA will maintain the source material. Missing data will be examined for any
systematic pattern of missingness. Mixed effects models are relatively insensitive to missing
data. If necessary, missing data will be replaced using standard statistical methods.
Standard statistical analysis approaches will be employed to evaluate the data for violation
of assumptions of the statistical models. Transformations will be performed as necessary.
Outcome variables will be compared statistically between the music listening and piano
training arms using repeated measures analysis of variance (or covariance) or mixed effects
models depending on the amount of missing data. Working memory will be assessed using the
Wechsler Intelligence Scale for Children (WISC) Digit span and picture span subtests.
Attention will be assessed using the Conners Continuous Performance Test 3 (CPT3). Behavioral
regulation will be assessed using the Behavioral Rating Inventory of Executive Function 2
(BRIEF2). Age, socioeconomic status, and music experience will be included as covariates in
the model, as needed. Sex effects on outcome variables will also be examined.
H1: Piano training will produce improvements in behavioral regulation (BRIEF2) relative to
music listening.
H2: Piano training will produce improvements in attention (Conners CPT 3) relative to music
listening.
H3: Piano training will produce improvements in working memory (WISC - Digit span) relative
to music listening.