AnxietySPARKNCT06945497
School-based Practices in Arts and Resilience for Kids
A study testing Art Therapy and Yoga/Mindfulness in people with Anxiety and Posttraumatic Stress Disorder, run by Wayne State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Posttraumatic Stress Disorder, Trauma
- What is being tested?
- Art Therapy and Yoga/Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Current or past bipolar I/II disorder
- Current or past psychotic disorder
- Autism spectrum disorders or any other severe developmental disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Chandler Park Academy Middle School
Harper Woods, Michigan, 48225
Cali Ashby, 313-499-3308, ashbyc@chandlerparkacademy.net
Jefferson Middle School
Saint Clair Shores, Michigan, 48081
Laura Woods, Ph.D., 586-445-4000, Lwoods@SCSLAKEVIEW-K12.com
About this study
Official title: School-based Practices in Arts and Resilience for Kids (SPARK Study)
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).
Read the detailed description
Early life experiences impact development and have lasting effects on health and behavior. Negative childhood experiences (adversity, trauma; e.g., caregiver neglect or maltreatment, community violence, forced migration, discrimination, and harassment, increase the risk for negative mental health outcomes across the lifespan. These negative mental health outcomes include, but are not limited to, posttraumatic stress, anxiety, depression, pain, psychosis, suicidality, and other variation in variation in cognition and emotions. Negative childhood experiences, resultant physical and mental health problems, and associated treatment barriers disproportionately impact racially and ethnically minoritized (non-white) individuals. These disparities are, in part, resultant of historical systemic oppression, exclusion from economic opportunity, lack of representation in healthcare research, and intergenerational trauma exposure. Vulnerability to negative health outcomes may be driven by adversity-driven changes in neural pathways critical for emotion regulation, attention, memory processing, and other cognitive functions. These neural pathways are potentially modifiable with treatment, especially during more flexible developmental windows like childhood and adolescence. Given this, and that most psychiatric disorders onset in childhood or adolescence, the school age is the best time to intervene to mitigate future physical, mental, educational, and socioeconomic consequences of negative childhood experiences.
Barriers to accessing mental health care include lack of transportation, financial concerns, negative expectations surrounding seeking mental health services, medical mistrust rooted in historical injustice and trauma, and stigma. Therefore, there is a great need to facilitate healthy biopsychosocial development of youth by fostering resilience. Resilience, in part, is the ability to cope when faced with adversity. Cultivating resilience can protect against the negative impacts of childhood adversity. Fostering resilience can be achieved by teaching youth how to manage stress, regulate emotions and reactions, and resolve interpersonal disputes. One strategy to accomplish this at scale is by implementing school-based programs that support social-emotional learning. Expanding access to care and improving opportunities for youth via school-based mental health services can reduce disparities. Current gold-standard psychotherapy (e.g., cognitive behavioral therapy) and medication (e.g., serotonin-selective reuptake inhibitors) treat symptoms rather than cultivate resilience and are limited by availability, cost, accessibility, and adherence, especially for children and from individuals from disadvantaged backgrounds. Additionally, up to 50% of patients do not adequately respond to these treatments. These care models center around reactive, rather than proactive, care models based on research from predominantly white, highly educated, high socioeconomic status individuals. There is a need for a more diverse approach to methods of improving mental health with broader access for the general population and prevention/early interventions. Therefore, identifying accessible and cost-effective ways to reduce psychopathology and cultivate resilience in youth is a high priority to curb the myriad negative physical health, socioemotional, and economic sequelae.
To address the barriers to traditional forms of therapeutic care in youth, school-based art therapy and yoga/mindfulness pose as well-suited options. Art therapy, yoga, and mindfulness are interventions that target emotion (dys)regulation by integrating experientials that probe creativity, flexibility, and adaptability to better develop cognitive flexibility. Therapies that enhance emotion regulation and target underlying neural circuits may confer greater ability to dampen reactivity to stress and negative experiences. By offering these interventions in a group setting, school-based art therapy and yoga/mindfulness also has the opportunity to cultivate social support and peer interactions-fostering protective factors that have been found to reduce risk for mental illness in children and adolescents in a cost-effective and accessible manner. Offering such interventions at the group level may not only benefit those experiencing significant mental distress, but may also benefit those who are not experiencing such symptoms, as they will still reap the long-term benefits of building stress-relaxation and emotion regulation coping skills. Art therapy and yoga/mindfulness have all shown promise for reducing trauma, stress, anger, depression, obsessive compulsiveness, and anxiety.
One strategy to overcome mental healthcare barriers (e.g., transportation, finances, and stigma) and foster resilience in youth is to implement school-based programs that support social and emotional development. Art therapy and yoga/mindfulness have similar therapeutic goals to help children feel a sense of control and structure and reduce stress. Art therapy and yoga/mindfulness help children with self-regulation, resilience and promote well-being through increased awareness, healthy behaviors, and stress management in a cost-effective and accessible manner.The significant impact of these interventions will encourage a greater diversity of patients, physicians, and communities to participate in and support use of arts and mindfulness interventions as a main mode of cost-effective and accessible treatment.
The present proposal is directly responsive to Senate Resolution 769 from the 118th Congress to "support student well-being through evidence-based prevention strategies" give the gross "lack [of] adequate services and support when dealing with mental health challenges and crises." School and community settings offer viable venues for broad-scale implementation of interventions. Art therapy and yoga/mindfulness may be favorable for youth implemented in schools and community settings for a) augmenting healthcare services youth may receive, b) providing an accessible and affordable option for youth untreated due to lack of access to care, cost, or stigmatization, and c) instill coping skills and relaxation techniques in youth who have experienced adversity and discrimination.
Vulnerability to negative health outcomes may be driven by adversity-driven changes in neural pathways critical for emotion regulation, attention, memory processing, and other cognitive functions. These neural pathways are potentially modifiable with treatment, especially during more flexible developmental windows like childhood and adolescence. Given this, and that most psychiatric disorders onset in childhood or adolescence, the school age is the best time to intervene to mitigate future physical, mental, educational, and socioeconomic consequences of negative childhood experiences.
- Conditions
- Anxiety, Posttraumatic Stress Disorder, Trauma
- Being tested
- Art Therapy, Yoga/Mindfulness
- Keywords
- Adversity, Trauma, Stress, Anxiety, Posttraumatic Stress Disorder, Art Therapy, Yoga, Mindfulness, Child and Adolescent
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
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.
Yoga/MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy, Yoga/Mindfulness | Experimental | In this arm, participants will first engage in art therapy, then yoga/mindfulness interventions. Receives: Behavioral: Art Therapy; Behavioral: Yoga/Mindfulness |
| Yoga/Mindfulness, Art Therapy | Experimental | In this arm, participants will first engage in yoga/mindfulness, then art therapy interventions. Receives: Behavioral: Art Therapy; Behavioral: Yoga/Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (3)
Posttraumatic Stress
We will measure severity of self-reported post traumatic stress symptoms in youth who endorse at least one traumatic exposure. To measure traumatic exposures and PTSD symptoms, we will use the UCLA PTSD Reaction Index. The UCLA PTSD RI is a valid and reliable measure developed for children and adolescents ages 7-17. The first component of the measures captures the index trauma (Criterion A), and the second component assesses the core symptoms of PTSD - reexperiencing / intrusive symptoms (Criterion B), avoidance (Criterion C), negative changes in cognitions and mood (Criterion D), arousal (Criterion E), and dissociative symptoms (Dissociative Subtype). We will measure symptoms before, during, and after the intervention, up to three months post interventions, for a total duration of one year.
Measured: One year
Depression
We will measure self-reported severity of depression. To measure self-reported severity of depression, we will use the Mood and Feelings Questionnaire. The Mood and Feelings Questionnaire is a valid and reliable measure for assessing symptoms related to depression in children and adolescents. We will measure symptoms before, during, and after the intervention, up to three months post interventions, for a total duration of one year.
Measured: One year
Resilience
We will measure self-reports of resilience using the Brief Resilience Scale. We will measure resilience before, during, and after the intervention, up to three months post interventions, for a total duration of one year.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Chandler Park Academy, Jefferson Middle School, Lakeview Public Schools
- Responsible party
- Principal investigator, Lana Ruvolo Grasser, Wayne State University
- Investigators
- Lana R Grasser, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945497
- Sponsor's protocol ID
- 25-02-7541
- Acronym
- SPARK
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Grasser LR, Marusak H. Strong Mind, Strong Body: The Promise of Mind-Body Interventions to Address Growing Mental Health Needs Among Youth. Mental Health Sci. 2023 Jun;1(2):58-66. doi: 10.1002/mhs2.16. Epub 2023 Mar 22.
PubMed 37810896Lesté A, Rust J. Effects of dance on anxiety. American Journal of Dance Therapy. 1990/03/01 1990;12(1):19-25. doi:10.1007/BF00844312
Lee H-J, Jang S-H, Lee S-Y, Hwang K-S. Effectiveness of dance/movement therapy on affect and psychotic symptoms in patients with schizophrenia. The Arts in Psychotherapy. 2015/09/01/ 2015;45:64-68. doi:https://doi.org/10.1016/j.aip.2015.07.003
Grasser LR, Al-Saghir H, Wanna C, Spinei J, Javanbakht A. Moving Through the Trauma: Dance/Movement Therapy as a Somatic-Based Intervention for Addressing Trauma and Stress Among Syrian Refugee Children. J Am Acad Child Adolesc Psychiatry. 2019 Nov;58(11):1124-1126. doi: 10.1016/j.jaac.2019.07.007. Epub 2019 Jul 23.
PubMed 31348987Feen-Calligan H, Ruvolo Grasser L, Debryn J, et al. Art therapy with Syrian refugee youth in the United States: An intervention study. The Arts in Psychotherapy. 2020/07/01/ 2020;69:101665. doi:https://doi.org/10.1016/j.aip.2020.101665
Feder A, Fred-Torres S, Southwick SM, Charney DS. The Biology of Human Resilience: Opportunities for Enhancing Resilience Across the Life Span. Biol Psychiatry. 2019 Sep 15;86(6):443-453. doi: 10.1016/j.biopsych.2019.07.012. Epub 2019 Jul 24.
PubMed 31466561Brown EC, Graham JW, Hawkins JD, Arthur MW, Baldwin MM, Oesterle S, Briney JS, Catalano RF, Abbott RD. Design and analysis of the Community Youth Development Study longitudinal cohort sample. Eval Rev. 2009 Aug;33(4):311-34. doi: 10.1177/0193841X09337356. Epub 2009 Jun 9.
PubMed 19509119Lerner RM, Lerner JV, Almerigi JB, et al. Positive youth development, participation in community youth development programs, and community contributions of fifth grade adolescents: findings from the First Wave of the 4-H Study of Positive Youth Development. The Journal of Early Adolescence. 2005;25:17-71.
Minton SC, Faber R. Thinking with the Dancing Brain: Embodying Neuroscience. Rowman & Littlefield; 2016.
Bailey JM, Bartlem KM, Wiggers JH, Wye PM, Stockings EAL, Hodder RK, Metse AP, Regan TW, Clancy R, Dray JA, Tremain DL, Bradley T, Bowman JA. Systematic review and meta-analysis of the provision of preventive care for modifiable chronic disease risk behaviours by mental health services. Prev Med Rep. 2019 Aug 14;16:100969. doi: 10.1016/j.pmedr.2019.100969. eCollection 2019 Dec.
PubMed 31497500Henrich J, Heine SJ, Norenzayan A. Most people are not WEIRD. Nature. 2010 Jul 1;466(7302):29. doi: 10.1038/466029a. No abstract available.
PubMed 20595995Alegría M, Green JG, McLaughlin KA, Loder S. Disparities in child and adolescent mental health and mental health services in the US. New York, NY: William T Grant Foundation. 2015:26.
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.
PubMed 33734797Slopen 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.
PubMed 26342634Bremner 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.
PubMed 38088987
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Practices in Arts and Resilience for Kids (SPARK Study)
- ClinicalTrials.gov ID
- NCT06945497
- Acronym / sponsor ID
- SPARK / 25-02-7541
- Conditions
- Anxiety, Posttraumatic Stress Disorder, Trauma
- Keywords
- Adversity, Trauma, Stress, Anxiety, Posttraumatic Stress Disorder, Art Therapy, Yoga, Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Chandler Park Academy, Jefferson Middle School, Lakeview Public Schools
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 25 Apr 2025 (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.
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).
Detailed description
Early life experiences impact development and have lasting effects on health and behavior. Negative childhood experiences (adversity, trauma; e.g., caregiver neglect or maltreatment, community violence, forced migration, discrimination, and harassment, increase the risk for negative mental health outcomes across the lifespan. These negative mental health outcomes include, but are not limited to, posttraumatic stress, anxiety, depression, pain, psychosis, suicidality, and other variation in variation in cognition and emotions. Negative childhood experiences, resultant physical and mental health problems, and associated treatment barriers disproportionately impact racially and ethnically minoritized (non-white) individuals. These disparities are, in part, resultant of historical systemic oppression, exclusion from economic opportunity, lack of representation in healthcare research, and intergenerational trauma exposure. Vulnerability to negative health outcomes may be driven by adversity-driven changes in neural pathways critical for emotion regulation, attention, memory processing, and other cognitive functions. These neural pathways are potentially modifiable with treatment, especially during more flexible developmental windows like childhood and adolescence. Given this, and that most psychiatric disorders onset in childhood or adolescence, the school age is the best time to intervene to mitigate future physical, mental, educational, and socioeconomic consequences of negative childhood experiences.
Barriers to accessing mental health care include lack of transportation, financial concerns, negative expectations surrounding seeking mental health services, medical mistrust rooted in historical injustice and trauma, and stigma. Therefore, there is a great need to facilitate healthy biopsychosocial development of youth by fostering resilience. Resilience, in part, is the ability to cope when faced with adversity. Cultivating resilience can protect against the negative impacts of childhood adversity. Fostering resilience can be achieved by teaching youth how to manage stress, regulate emotions and reactions, and resolve interpersonal disputes. One strategy to accomplish this at scale is by implementing school-based programs that support social-emotional learning. Expanding access to care and improving opportunities for youth via school-based mental health services can reduce disparities. Current gold-standard psychotherapy (e.g., cognitive behavioral therapy) and medication (e.g., serotonin-selective reuptake inhibitors) treat symptoms rather than cultivate resilience and are limited by availability, cost, accessibility, and adherence, especially for children and from individuals from disadvantaged backgrounds. Additionally, up to 50% of patients do not adequately respond to these treatments. These care models center around reactive, rather than proactive, care models based on research from predominantly white, highly educated, high socioeconomic status individuals. There is a need for a more diverse approach to methods of improving mental health with broader access for the general population and prevention/early interventions. Therefore, identifying accessible and cost-effective ways to reduce psychopathology and cultivate resilience in youth is a high priority to curb the myriad negative physical health, socioemotional, and economic sequelae.
To address the barriers to traditional forms of therapeutic care in youth, school-based art therapy and yoga/mindfulness pose as well-suited options. Art therapy, yoga, and mindfulness are interventions that target emotion (dys)regulation by integrating experientials that probe creativity, flexibility, and adaptability to better develop cognitive flexibility. Therapies that enhance emotion regulation and target underlying neural circuits may confer greater ability to dampen reactivity to stress and negative experiences. By offering these interventions in a group setting, school-based art therapy and yoga/mindfulness also has the opportunity to cultivate social support and peer interactions-fostering protective factors that have been found to reduce risk for mental illness in children and adolescents in a cost-effective and accessible manner. Offering such interventions at the group level may not only benefit those experiencing significant mental distress, but may also benefit those who are not experiencing such symptoms, as they will still reap the long-term benefits of building stress-relaxation and emotion regulation coping skills. Art therapy and yoga/mindfulness have all shown promise for reducing trauma, stress, anger, depression, obsessive compulsiveness, and anxiety.
One strategy to overcome mental healthcare barriers (e.g., transportation, finances, and stigma) and foster resilience in youth is to implement school-based programs that support social and emotional development. Art therapy and yoga/mindfulness have similar therapeutic goals to help children feel a sense of control and structure and reduce stress. Art therapy and yoga/mindfulness help children with self-regulation, resilience and promote well-being through increased awareness, healthy behaviors, and stress management in a cost-effective and accessible manner.The significant impact of these interventions will encourage a greater diversity of patients, physicians, and communities to participate in and support use of arts and mindfulness interventions as a main mode of cost-effective and accessible treatment.
The present proposal is directly responsive to Senate Resolution 769 from the 118th Congress to "support student well-being through evidence-based prevention strategies" give the gross "lack [of] adequate services and support when dealing with mental health challenges and crises." School and community settings offer viable venues for broad-scale implementation of interventions. Art therapy and yoga/mindfulness may be favorable for youth implemented in schools and community settings for a) augmenting healthcare services youth may receive, b) providing an accessible and affordable option for youth untreated due to lack of access to care, cost, or stigmatization, and c) instill coping skills and relaxation techniques in youth who have experienced adversity and discrimination.
Vulnerability to negative health outcomes may be driven by adversity-driven changes in neural pathways critical for emotion regulation, attention, memory processing, and other cognitive functions. These neural pathways are potentially modifiable with treatment, especially during more flexible developmental windows like childhood and adolescence. Given this, and that most psychiatric disorders onset in childhood or adolescence, the school age is the best time to intervene to mitigate future physical, mental, educational, and socioeconomic consequences of negative childhood experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy, Yoga/Mindfulness | Experimental | Behavioral: Art Therapy, Behavioral: Yoga/MindfulnessIn this arm, participants will first engage in art therapy, then yoga/mindfulness interventions. |
| Yoga/Mindfulness, Art Therapy | Experimental | Behavioral: Art Therapy, Behavioral: Yoga/MindfulnessIn this arm, participants will first engage in yoga/mindfulness, then art therapy interventions. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Current or past bipolar I/II disorder
- Current or past psychotic disorder
- Autism spectrum disorders or any other severe developmental disorder
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 |
|---|---|---|
| Art TherapyThe 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. | Behavioural | Art Therapy, Yoga/Mindfulness, Yoga/Mindfulness, Art Therapy |
| Yoga/MindfulnessThe 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. | Behavioural | Art Therapy, Yoga/Mindfulness, Yoga/Mindfulness, Art Therapy |
Primary outcome
Anxiety
Time frame: One year
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.
3 secondary outcomes
Posttraumatic Stress
Time frame: One year
Depression
Time frame: One year
Resilience
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 37810896Grasser LR, Marusak H. Strong Mind, Strong Body: The Promise of Mind-Body Interventions to Address Growing Mental Health Needs Among Youth. Mental Health Sci. 2023 Jun;1(2):58-66. doi: 10.1002/mhs2.16. Epub 2023 Mar 22.
- BackgroundLesté A, Rust J. Effects of dance on anxiety. American Journal of Dance Therapy. 1990/03/01 1990;12(1):19-25. doi:10.1007/BF00844312
- BackgroundLee H-J, Jang S-H, Lee S-Y, Hwang K-S. Effectiveness of dance/movement therapy on affect and psychotic symptoms in patients with schizophrenia. The Arts in Psychotherapy. 2015/09/01/ 2015;45:64-68. doi:https://doi.org/10.1016/j.aip.2015.07.003
- Background: PubMed 31348987Grasser LR, Al-Saghir H, Wanna C, Spinei J, Javanbakht A. Moving Through the Trauma: Dance/Movement Therapy as a Somatic-Based Intervention for Addressing Trauma and Stress Among Syrian Refugee Children. J Am Acad Child Adolesc Psychiatry. 2019 Nov;58(11):1124-1126. doi: 10.1016/j.jaac.2019.07.007. Epub 2019 Jul 23.
- BackgroundFeen-Calligan H, Ruvolo Grasser L, Debryn J, et al. Art therapy with Syrian refugee youth in the United States: An intervention study. The Arts in Psychotherapy. 2020/07/01/ 2020;69:101665. doi:https://doi.org/10.1016/j.aip.2020.101665
- Background: PubMed 31466561Feder A, Fred-Torres S, Southwick SM, Charney DS. The Biology of Human Resilience: Opportunities for Enhancing Resilience Across the Life Span. Biol Psychiatry. 2019 Sep 15;86(6):443-453. doi: 10.1016/j.biopsych.2019.07.012. Epub 2019 Jul 24.
- Background: PubMed 19509119Brown EC, Graham JW, Hawkins JD, Arthur MW, Baldwin MM, Oesterle S, Briney JS, Catalano RF, Abbott RD. Design and analysis of the Community Youth Development Study longitudinal cohort sample. Eval Rev. 2009 Aug;33(4):311-34. doi: 10.1177/0193841X09337356. Epub 2009 Jun 9.
- BackgroundLerner RM, Lerner JV, Almerigi JB, et al. Positive youth development, participation in community youth development programs, and community contributions of fifth grade adolescents: findings from the First Wave of the 4-H Study of Positive Youth Development. The Journal of Early Adolescence. 2005;25:17-71.
- BackgroundMinton SC, Faber R. Thinking with the Dancing Brain: Embodying Neuroscience. Rowman & Littlefield; 2016.
- Background: PubMed 31497500Bailey JM, Bartlem KM, Wiggers JH, Wye PM, Stockings EAL, Hodder RK, Metse AP, Regan TW, Clancy R, Dray JA, Tremain DL, Bradley T, Bowman JA. Systematic review and meta-analysis of the provision of preventive care for modifiable chronic disease risk behaviours by mental health services. Prev Med Rep. 2019 Aug 14;16:100969. doi: 10.1016/j.pmedr.2019.100969. eCollection 2019 Dec.
- Background: PubMed 20595995Henrich J, Heine SJ, Norenzayan A. Most people are not WEIRD. Nature. 2010 Jul 1;466(7302):29. doi: 10.1038/466029a. No abstract available.
- BackgroundAlegría M, Green JG, McLaughlin KA, Loder S. Disparities in child and adolescent mental health and mental health services in the US. New York, NY: William T Grant Foundation. 2015:26.
- Individual participant dataSharing planned: Yes. 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.
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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.
Lana R Grasser, Ph.D. principal investigator
Wayne State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy and Yoga/Mindfulness in people with Anxiety and Posttraumatic Stress Disorder, run by Wayne State University at 2 sites 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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lana R Grasser, Ph.D. (313-389-1777, lgrasser@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945497, which also lists 29 linked publications.
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 25 Apr 2025.