MCRF Clinical Pilot Study

Emotional Adjustment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991585
• Other study ID #: 20190108
• Status: Completed
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotional Adjustment

Intervention

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.

Locations

Country	Name	City	State
United States	St. Albans Child Enrichment Center Coconut Grove	Coconut Grove	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	American Music Therapy Association, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Percentage of study measures completed	Will be measured by adding the number of measures completed divided by total number of measured administered.	12 weeks
Secondary	Percentage of child attendance	Will be measured by adding the number of study sessions completed divided by total number of study sessions.	12 weeks
Secondary	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