MCRF Clinical Pilot Study

NCT03991585 | Completed

• 1 other identifier: 20190108
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Emotional Adjustment

Keywords

At-risk preschoolers; Head Start; Emotion regulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in emotion regulation state as self-reported using the Self Assessment Manikin (SAM)

  Pre-session, 20-minute post-session

• Change in emotion regulation state as observed using the Goal Attainment Scale (GAS)

  Pre-session, 20-minute post-session

• Percentage of study measures completed

  12 weeks

• Percentage of child attendance

  12 weeks

• Percentage of intervention components completed by interventionist

  12 weeks

Study Arms (2)

Three times a week MCRF

EXPERIMENTAL

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)

One time a week MCRF

EXPERIMENTAL

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)

Interventions

Musical Contour Regulation Facilitation (MCRF) BEHAVIORAL

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.

One time a week MCRF; Three times a week MCRF

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• American Music Therapy Association: collaborator
• University of Kansas: collaborator

Study Sites (1)

St. Albans Child Enrichment Center Coconut Grove

Coconut Grove, Florida, 33133, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Kimberly Sena Moore, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Professional Practice

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

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: July 24, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)