MCRF Clinical Pilot Study

Not Applicable

Completed

• Conditions: Emotional Adjustment
• Interventions: Behavioral: Musical Contour Regulation Facilitation (MCRF)

• Registration Number: NCT03991585
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-19
• Study Start: 2019-07-24
• Status Verified: 2020-01
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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Exclusion Criteria

• Does not meet all inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One time a week MCRF	Musical Contour Regulation Facilitation (MCRF)	Participants in this arm will participate in the MCRF intervention sessions one time a week for 12 consecutive weeks.
Three times a week MCRF	Musical Contour Regulation Facilitation (MCRF)	Participants in this arm will participate in the MCRF intervention sessions three times a week for 12 consecutive weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Albans Child Enrichment Center Coconut Grove; 🇺🇸 Coconut Grove, Florida, United States