Project SOLVE: Trial of a Brief Digital Problem-solving Intervention

Depression Clinical Trial

Official title:

Project SOLVE: A School-based Trial of a Universal Single-session Digital Problem-solving Intervention for Adolescent Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806321
• Other study ID #: IRB20-1791
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: July 2022
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress

Intervention

Other:
• Project SOLVE
This 30-minute, self-guided, digital program is designed to help adolescents solve, rather than be overwhelmed by, everyday problems.
• Project SUCCESS
This 30-minute, self-guided, digital program is designed to help adolescents develop study skills.

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 3-month Follow-Up	Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.	Baseline to 3-month follow-up
Primary	Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 12-month Follow-Up	Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.	Baseline to 12-month follow-up
Primary	Change in State Hope Scale Pathways Subscale From Immediately Pre-Intervention to Immediately Post-Intervention	Change in self-reported hopefulness, as measured via the 3-item "pathways" (planning of ways to meet goals) subscale of the State Hope Scale. Each item is rated on a 1-8 scale and total scores range from 1 to 24, with higher scores indicating higher levels of hopefulness.	Immediately pre-intervention to immediately post-intervention
Primary	Change in Beck Hopelessness Scale From Immediately Pre-Intervention to Immediately Post-Intervention	The Beck Hopelessness Scale (BHS) asks adolescents to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total score ranges from 0 to 12, with higher scores indicating greater levels of hopelessness.	Immediately pre-intervention to immediately post-intervention
Secondary	Perceived Program Acceptability and Helpfulness	Post-intervention feedback on the program's perceived acceptability and helpfulness as measured via a 7-item scale, with each item rated on a 1-5 scale, with higher scores indicating greater acceptability and helpfulness.	Immediately post-intervention
Secondary	Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 3-month Follow-Up	Trajectories of self-reported misbehavior from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Externalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.	Baseline to 3-month follow-up
Secondary	Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 12-month Follow-Up	Trajectories of self-reported misbehavior from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Externalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.	Baseline to 12-month follow-up
Secondary	Change in State Hope Scale From Baseline to 3-Month Follow-Up	Change in self-reported total hopefulness from the 6-item (each item rated on a 1-8 scale, with higher scores indicating greater hopefulness) State Hope Scale, as well as self-reported scores on the 3-item "agency" (goal-directed determination) and 3-item "pathways" (planning of ways to meet goals) subscales of this measure.	Baseline to 3-month follow-up
Secondary	Change in State Hope Scale From Baseline to 12-Month Follow-Up	Change in self-reported total hopefulness from the 6-item (each item rated on a 1-8 scale, with higher scores indicating greater hopefulness) State Hope Scale, as well as self-reported scores on the 3-item "agency" (goal-directed determination) and 3-item "pathways" (planning of ways to meet goals) subscales of this measure.	Baseline to 12-month follow-up
Secondary	Change in Beck Hopelessness Scale From Baseline to 3-Month Follow-Up	The Beck Hopelessness Scale (BHS) asks adolescents to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total score ranges from 0 to 12, with higher scores indicating greater levels of hopelessness.	Baseline to 3-month follow-up
Secondary	Change in Beck Hopelessness Scale From Baseline to 12-Month Follow-Up	The Beck Hopelessness Scale (BHS) asks adolescents to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Total score ranges from 0 to 12, with higher scores indicating greater levels of hopelessness.	Baseline to 12-month follow-up