Emotional AdjustmentNCT03991585
MCRF Clinical Pilot Study
A study testing Musical Contour Regulation Facilitation (MCRF) in people with Emotional Adjustment, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if music can help children practice how to manage their emotions. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Adjustment
- What is being tested?
- Musical Contour Regulation Facilitation (MCRF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Does not meet all inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Albans Child Enrichment Center Coconut Grove
Coconut Grove, Florida, 33133
About this study
Official title: Feasibility of the Musical Contour Regulation Facilitation (MCRF) Intervention to Promote Emotion Regulation in At-risk Preschoolers: A Clinical Pilot Study
The purpose of this study is to see if music can help children practice how to manage their emotions.
- Conditions
- Emotional Adjustment
- Being tested
- Musical Contour Regulation Facilitation (MCRF)
- Keywords
- At-risk preschoolers, Head Start, Emotion regulation
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical Contour Regulation Facilitation (MCRF)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Musical Contour Regulation Facilitation (MCRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Percentage of child attendance
Will be measured by adding the number of study sessions completed divided by total number of study sessions.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start24 Jul 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional AdjustmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are six classroom assignments. Classrooms will be randomized to either of the treatment arms.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Music Therapy Association, University of Kansas
- Responsible party
- Principal investigator, Kimberly Sena Moore, University of Miami
- Investigators
- Kimberly Sena Moore, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991585
- Sponsor's protocol ID
- 20190108
- Status last verified
- Jan 2020
- First submitted
- 17 Jun 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Musical Contour Regulation Facilitation (MCRF) Intervention to Promote Emotion Regulation in At-risk Preschoolers: A Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT03991585
- Acronym / sponsor ID
- 20190108
- Conditions
- Emotional Adjustment
- Keywords
- At-risk preschoolers, Head Start, Emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Music Therapy Association, University of Kansas
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if music can help children practice how to manage their emotions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are six classroom assignments. Classrooms will be randomized to either of the treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Three times a week MCRF | Experimental | Behavioral: Musical Contour Regulation Facilitation (MCRF)Participants in this arm will participate in the MCRF intervention sessions three times a week for 12 consecutive weeks. |
| One time a week MCRF | Experimental | Behavioral: Musical Contour Regulation Facilitation (MCRF)Participants in this arm will participate in the MCRF intervention sessions one time a week for 12 consecutive weeks. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | One time a week MCRF, Three times a week MCRF |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Change in emotion regulation state as self-reported using the Self Assessment Manikin (SAM)
Time frame: Pre-session, 20-minute post-session
Change in emotion regulation state as observed using the Goal Attainment Scale (GAS)
Time frame: Pre-session, 20-minute post-session
Percentage of study measures completed
Time frame: 12 weeks
Percentage of child attendance
Time frame: 12 weeks
Percentage of intervention components completed by interventionist
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Sena Moore, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical Contour Regulation Facilitation (MCRF) in people with Emotional Adjustment, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in emotion regulation as measured by Emotion Regulation Checklist (ERC) (time frame: Baseline, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.