Clinical trial NCT06945497: School-based Practices in Arts and Resilience for Kids
Official title: School-based Practices in Arts and Resilience for Kids (SPARK Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Posttraumatic Stress Disorder
Trauma
Keywords: Adversity
Trauma
Stress
Anxiety
Posttraumatic Stress Disorder
Art Therapy
Yoga
Mindfulness
Child and Adolescent
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Chandler Park Academy
name: Jefferson Middle School
name: Lakeview Public Schools
First posted: 2025-04-25
Enrollment: 250
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Ages 11-14 years, inclusive.
2. Any gender identity or sex assigned at birth.
3. English-speaking, given that study interventions and assessments will be in English.
4. Ability to provide written informed assent or oral assent.
5. Caregiver ability to provide informed consent and ability to assist in completing study.
6. Student enrolled in collaborating school.

Note: here, we define 'caregiver' as the participant's parent and/or legal guardian.

Exclusion Criteria:

1. Current or past bipolar I/II disorder
2. Current or past psychotic disorder
3. Autism spectrum disorders or any other severe developmental disorder

Primary outcomes:
measure: Anxiety
timeFrame: One year
Secondary outcomes:
measure: Posttraumatic Stress
timeFrame: One year
measure: Depression
timeFrame: One year
measure: Resilience
timeFrame: One year
Other outcomes:
Locations:
city: Harper Woods
country: United States
facility: Chandler Park Academy Middle School
state: Michigan
city: Saint Clair Shores
country: United States
facility: Jefferson Middle School
state: Michigan
Study officials:
affiliation: Wayne State University
name: Lana R Grasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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