MCRF Clinical Pilot Study

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

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

Conditions
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Emotional Adjustment

Intervention / Treatment
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* Behavioral: Musical Contour Regulation Facilitation (MCRF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are six classroom assignments. Classrooms will be randomized to either of the treatment arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three times a week MCRF<br>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)<br>* 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.<br>|
| Experimental: One time a week MCRF<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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At-risk preschoolers, Head Start, Emotion regulation