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

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

Study Overview

• Status: Completed
• Conditions: Emotional Adjustment
• Intervention / Treatment: Behavioral: Musical Contour Regulation Facilitation (MCRF)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coconut Grove, Florida, United States, 33133
      • St. Albans Child Enrichment Center Coconut Grove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three times a week MCRF; Participants in this arm will participate in the MCRF intervention sessions three times a week for 12 consecutive weeks.	Behavioral: Musical 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.
Experimental: One time a week MCRF; Participants in this arm will participate in the MCRF intervention sessions one time a week for 12 consecutive weeks.	Behavioral: Musical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotion regulation as measured by Emotion Regulation Checklist (ERC)	The 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.	Baseline, 12 weeks
Change in emotional lability/negativity as measured by Emotion Regulation Checklist (ERC)	The 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.	Baseline, 12 weeks
Change in behaviors as measured by the Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)	The 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.	Baseline, 12 weeks
Change in behaviors as measured by the Caregiver-Teacher Report Form (C-TRF)	The 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.	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotion regulation state as self-reported using the Self Assessment Manikin (SAM)	The 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.	Pre-session, 20-minute post-session
Change in emotion regulation state as observed using the Goal Attainment Scale (GAS)	The 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.	Pre-session, 20-minute post-session
Percentage of study measures completed	Will be measured by adding the number of measures completed divided by total number of measured administered.	12 weeks
Percentage of child attendance	Will be measured by adding the number of study sessions completed divided by total number of study sessions.	12 weeks
Percentage of intervention components completed by interventionist	Measured 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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: University of Kansas; American Music Therapy Association
• Investigators: Principal Investigator: Kimberly Sena Moore, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Head Start; Emotion regulation; At-risk preschoolers
• Other Study ID Numbers: 20190108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No