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Completed

NCT Number: NCT03991585

MCRF Clinical Pilot Study

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

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Key information

Conditions

Emotional Adjustment Behavior Emotional Regulation Self-Control Social Behavior

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Albans Child Enrichment Center Coconut Grove

Coconut Grove, Florida, 33133, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in emotion regulation as measured by Emotion Regulation Checklist (ERC)

    Time frame: 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.

  2. Change in emotional lability/negativity as measured by Emotion Regulation Checklist (ERC)

    Time frame: 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.

  3. Change in behaviors as measured by the Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)

    Time frame: 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.

  4. Change in behaviors as measured by the Caregiver-Teacher Report Form (C-TRF)

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Percentage of study measures completed

    Time frame: 12 weeks

    Will be measured by adding the number of measures completed divided by total number of measured administered.

  4. Percentage of child attendance

    Time frame: 12 weeks

    Will be measured by adding the number of study sessions completed divided by total number of study sessions.

  5. Percentage of intervention components completed by interventionist

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • American Music Therapy Association
  • University of Kansas

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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