Clinical trial NCT04806321: Project SOLVE: Trial of a Brief Digital Problem-solving Intervention
Official title: Project SOLVE: A School-based Trial of a Universal Single-session Digital Problem-solving Intervention for Adolescent Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Stress
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 522
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants (anticipated N = 1,000), ages 10-14 years old, will be randomized to complete one of two 30-minute, digital programs: (1) Project SOLVE: a program designed to teach adolescents how to solve, rather than be overwhelmed by, everyday problems; or (2) Project SUCCESS: a control program designed to teach adolescents helpful study skills.
Primary purpose: PREVENTION

Brief summary: The goal of this trial is to examine the effectiveness of a universal, self-guided, digital single-session intervention focusing on problem-solving skills in improving adolescent mental health and well-being, relative to an active control intervention focusing on study skills, within the context of school settings during the coronavirus disease pandemic.

Detailed description: More than 20% of adolescents will experience at least one mental health disorder or problem before adulthood that warrants treatment, yet 80% of these adolescents will never receive care. This need-to-access gap appears to be heightened during the current coronavirus disease pandemic and its resulting disruptions to healthcare and education systems. Both within and beyond the context of the pandemic, preventive mental health interventions are positioned to help adolescents build and strengthen coping strategies that can preclude the emergence of mental health difficulties that require more resource-intensive levels of clinical care. Preventive mental health interventions delivered via digital platforms and within school-based settings might be especially scalable.

The current school-based trial is designed to test one such strategy that harnesses technology to boost the scalability of adolescent mental health interventions: a brief (one 30 minute session) digital program designed to empower adolescents (10-14 years old) to solve, rather than be overwhelmed by, everyday problems (Project SOLVE). Single-session interventions designed to help adolescents cultivate adaptive mindsets have reduced anxiety and depression among adolescents with and without elevated symptoms of these disorders. Building on this strong foundation, Project SOLVE targets these mental health challenges with problem solving skills-one of the most versatile, commonly used, and potent therapeutic techniques for adolescents.

Eligibility criteria: Inclusion Criteria:

* Adolescent is in grades 6-8 (inclusive) at partnering schools
* Adolescent is between the ages of 10-14 years (inclusive) at the time of study enrollment
* Adolescent and at least one guardian consent to adolescent participation in study
* Adolescent reads English well enough to effectively complete the digital programs
* Adolescent has access to a digital device

Exclusion Criteria:

* Adolescent is non-English speaking, as the programs are only available in English
* Adolescent does not have access to a digital device
* Adolescent has an intellectual disability that precludes comprehension of the program content

Primary outcomes:
measure: Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 3-month Follow-Up
timeFrame: Baseline to 3-month follow-up
measure: Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 12-month Follow-Up
timeFrame: Baseline to 12-month follow-up
measure: Change in State Hope Scale Pathways Subscale From Immediately Pre-Intervention to Immediately Post-Intervention
timeFrame: Immediately pre-intervention to immediately post-intervention
measure: Change in Beck Hopelessness Scale From Immediately Pre-Intervention to Immediately Post-Intervention
timeFrame: Immediately pre-intervention to immediately post-intervention
Secondary outcomes:
measure: Perceived Program Acceptability and Helpfulness
timeFrame: Immediately post-intervention
measure: Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 3-month Follow-Up
timeFrame: Baseline to 3-month follow-up
measure: Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 12-month Follow-Up
timeFrame: Baseline to 12-month follow-up
measure: Change in State Hope Scale From Baseline to 3-Month Follow-Up
timeFrame: Baseline to 3-month follow-up
measure: Change in State Hope Scale From Baseline to 12-Month Follow-Up
timeFrame: Baseline to 12-month follow-up
measure: Change in Beck Hopelessness Scale From Baseline to 3-Month Follow-Up
timeFrame: Baseline to 3-month follow-up
measure: Change in Beck Hopelessness Scale From Baseline to 12-Month Follow-Up
timeFrame: Baseline to 12-month follow-up
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
References: