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MCRF Clinical Pilot Study

Feasibility of the Musical Contour Regulation Facilitation (MCRF) Intervention to Promote Emotion Regulation in At-risk Preschoolers: A Clinical Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03991585
Enrollment
44
Registered
2019-06-19
Start date
2019-07-24
Completion date
2020-01-15
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Adjustment

Keywords

At-risk preschoolers, Head Start, Emotion regulation

Brief summary

The purpose of this study is to see if music can help children practice how to manage their emotions.

Interventions

BEHAVIORALMusical Contour Regulation Facilitation (MCRF)

MCRF involves 20-minute music therapy sessions comprised of seven interconnected components. Each session follows the same contour of neutral, low, and high arousal experiences facilitated through music.

Sponsors

American Music Therapy Association
CollaboratorOTHER
University of Kansas
CollaboratorOTHER
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

There are six classroom assignments. Classrooms will be randomized to either of the treatment arms.

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Preschoolers aged 3 to 5 years old enrolled in a Head Start program * Must be able to speak fluent English * Must not have previously received music therapy services * Must regularly attend the Head Start program * Must have signed parental consent.

Exclusion criteria

* Does not meet all inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Change in emotion regulation as measured by Emotion Regulation Checklist (ERC)Baseline, 12 weeksThe Emotion Regulation subscale of the ERC is an 8-item, four-point Likert-type scale to assess ER processes in children. Parents and teachers will complete the ERC pre- and post-intervention. Scores range from 8 to 32 points. Higher scores reflect greater emotion regulation.
Change in emotional lability/negativity as measured by Emotion Regulation Checklist (ERC)Baseline, 12 weeksThe Lability/Negativity subscale of the ERC is a 15-item, four-point Likert-type scale to assess emotional lability in children. Parents and teachers will complete the ERC pre- and post-intervention. Scores range from 15 to 60 points. Higher scores reflect greater emotional lability.
Change in behaviors as measured by the Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)Baseline, 12 weeksThe CBCL/1.5-5 is a 99-item, three-point Likert-type scale to assess internalizing behaviors, externalizing behaviors, attending behaviors, and aggressive in preschool-aged children. Parents will complete the CBCL/1.5-5 pre- and post-intervention. Scores range from 0 to 198 points. Higher scores reflect greater emotional problems.
Change in behaviors as measured by the Caregiver-Teacher Report Form (C-TRF)Baseline, 12 weeksThe C-TRF is a 99-item, three-point Likert-type scale to assess internalizing behaviors, externalizing behaviors, attending behaviors, and aggressive in preschool-aged children. Teachers will complete the CBCL/1.5-5 pre- and post-intervention. Scores range from 0 to 198 points. Higher scores reflect greater emotional problems.

Secondary

MeasureTime frameDescription
Change in emotion regulation state as self-reported using the Self Assessment Manikin (SAM)Pre-session, 20-minute post-sessionThe SAM is a nonverbal, picture-based, 5-point Likert-type measure of a child's self-reported levels of pleasure (i.e., valence) and arousal (i.e., energy level). Children will complete the SAM at the beginning and end of every intervention session. Scores range from 1 to 5. Higher scores reflect greater happiness and more energy.
Percentage of intervention components completed by interventionist12 weeksMeasured by using a self-developed Quality Assurance (QA) checklist that tallies the number of intervention components completed. Scores will range from 0 to 100 percent, with a higher score indicating greater interventionist fidelity.
Change in emotion regulation state as observed using the Goal Attainment Scale (GAS)Pre-session, 20-minute post-sessionThe GAS is a way to measure individualized clinical progress on a predetermined goal, i.e. preschooler emotion regulation state. The interventionist will complete the GAS at the beginning and end of every intervention session. Scores range from negative 2 to positive 2. Higher scores reflect greater emotion regulation.
Percentage of study measures completed12 weeksWill be measured by adding the number of measures completed divided by total number of measured administered.
Percentage of child attendance12 weeksWill be measured by adding the number of study sessions completed divided by total number of study sessions.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026