NCT06945497

Brief Summary

This proposal will implement and test feasibility and efficacy of school-based art therapy and yoga/mindfulness programming to reduce mental health disparities and foster resilience in youth. We will conduct a cross-over randomized trial with n=250 youth (any race/ethnicity or gender, ages 11-14) from two schools: one serving majority Black/African American students and one serving a population-representative ethnoracial demographic with 50% economically disadvantaged students. Baseline data collection will assess experiences of discrimination, negative experiences, positive experiences, and severity of posttraumatic stress, anxiety, depression, somatic symptoms, and resilience. Youth will be randomly assigned to art therapy or yoga/mindfulness for a quarter. Hour-long weekly sessions will occur during elective course times within school to bolster accessibility and generate data to inform future school-based care models for sustainability. Target schools co-developed this design with the research team. At the end of the quarter, participants will engage in post-intervention data collection, including qualitative interviews regarding their experience with the school-based programming. Participants will then cross over to the yoga/mindfulness or art therapy for the subsequent quarter, such that all participants receive both modalities. The methods described above will be repeated, including the assessments. Academic performance will be assessed throughout. We hypothesize that both modalities will be effective in reducing stress, anxiety, and depression related to discrimination, adversity, and trauma that disproportionately impacts racially and ethnically minoritized youth. We anticipate that qualitative feedback will identify points of optimization for programming and inform which students may be most responsive to what intervention(s).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Aug 2027

First Submitted

Initial submission to the registry

April 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

April 18, 2025

Last Update Submit

April 18, 2025

Conditions

Keywords

AdversityTraumaStressAnxietyPosttraumatic Stress DisorderArt TherapyYogaMindfulnessChild and Adolescent

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    We will measure severity of self-reported anxiety symptoms before, during, and after interventions, up to 3 months post interventions, for a total duration of one year. To measure severity of self-reported anxiety symptoms, we will use the Screen for Child Anxiety-Related Emotional Disorders, a valid and reliable measure for children and adolescents ages 7-17. The SCARED captures symptoms related to panic disorder / somatic symptoms, generalized anxiety disorder, separation anxiety, social anxiety, and school avoidance.

    One year

Secondary Outcomes (3)

  • Posttraumatic Stress

    One year

  • Depression

    One year

  • Resilience

    One year

Study Arms (2)

Art Therapy, Yoga/Mindfulness

EXPERIMENTAL

In this arm, participants will first engage in art therapy, then yoga/mindfulness interventions.

Behavioral: Art TherapyBehavioral: Yoga/Mindfulness

Yoga/Mindfulness, Art Therapy

EXPERIMENTAL

In this arm, participants will first engage in yoga/mindfulness, then art therapy interventions.

Behavioral: Art TherapyBehavioral: Yoga/Mindfulness

Interventions

Art TherapyBEHAVIORAL

The art therapy program will include different weekly experientials to explore mindfulness, establish safety, cultivate relaxation, find strength, honor self-identity, and cultivate community. Art media will include markers, colored pencils, fabrics, watercolors, collage, and yarn.

Art Therapy, Yoga/MindfulnessYoga/Mindfulness, Art Therapy

The yoga/mindfulness curriculum will explore consciousness (awareness of self and others), compassion, confidence, courage, and community. Each week, new movement and breathing exercises will be learned.

Art Therapy, Yoga/MindfulnessYoga/Mindfulness, Art Therapy

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages 11-14 years, inclusive.
  • Any gender identity or sex assigned at birth.
  • English-speaking, given that study interventions and assessments will be in English.
  • Ability to provide written informed assent or oral assent.
  • Caregiver ability to provide informed consent and ability to assist in completing study.
  • Student enrolled in collaborating school.
  • Note: here, we define 'caregiver' as the participant's parent and/or legal guardian.

You may not qualify if:

  • Current or past bipolar I/II disorder
  • Current or past psychotic disorder
  • Autism spectrum disorders or any other severe developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chandler Park Academy Middle School

Harper Woods, Michigan, 48225, United States

Location

Jefferson Middle School

Saint Clair Shores, Michigan, 48081, United States

Location

Related Publications (29)

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    BACKGROUND
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    PMID: 20595995BACKGROUND
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    BACKGROUND
  • Hampton-Anderson JN, Carter S, Fani N, Gillespie CF, Henry TL, Holmes E, Lamis DA, LoParo D, Maples-Keller JL, Powers A, Sonu S, Kaslow NJ. Adverse childhood experiences in African Americans: Framework, practice, and policy. Am Psychol. 2021 Feb-Mar;76(2):314-325. doi: 10.1037/amp0000767.

    PMID: 33734797BACKGROUND
  • Slopen N, Shonkoff JP, Albert MA, Yoshikawa H, Jacobs A, Stoltz R, Williams DR. Racial Disparities in Child Adversity in the U.S.: Interactions With Family Immigration History and Income. Am J Prev Med. 2016 Jan;50(1):47-56. doi: 10.1016/j.amepre.2015.06.013. Epub 2015 Sep 2.

    PMID: 26342634BACKGROUND
  • Bremner JD, Ortego RA, Campanella C, Nye JA, Davis LL, Fani N, Vaccarino V. Neural correlates of PTSD in women with childhood sexual abuse with and without PTSD and response to paroxetine treatment: A placebo-controlled, double-blind trial. J Affect Disord Rep. 2023 Dec;14:100615. doi: 10.1016/j.jadr.2023.100615. Epub 2023 Jun 24.

    PMID: 38088987BACKGROUND
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    PMID: 35811064BACKGROUND
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    PMID: 33862062BACKGROUND
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    PMID: 33080297BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersStress Disorders, Post-TraumaticWounds and Injuries

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Mental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lana R Grasser, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lana R Grasser, Ph.D.

CONTACT

Ujala Janjua

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 25, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified data that does not include any personal identifying information (e.g., date of birth, social security number, contact information, names, etc.) will be shared. This includes, but is not limited to, non-PII demographic information, reports of positive and negative (e.g., discrimination, adversity, trauma) experiences, severity of self-reported anxiety, depression, and post traumatic stress disorder, and resilience. Item-level as well as scored data will be shared according to published guidelines.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
We will share IPD and supporting information within three years of the end date of data collection. Data will be shared indefinitely (no end date), unless individual participants choose to withdraw their data from data sharing.
Access Criteria
IPD and supporting information will be publicly accessible via GitHub, an online website that is free/open source.
More information

Locations