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Completed

NCT Number: NCT04806321

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard University

Cambridge, Massachusetts, 02138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project SOLVE

Other

This 30-minute, self-guided, digital program is designed to help adolescents solve, rather than be overwhelmed by, everyday problems.

Project SUCCESS

Other

This 30-minute, self-guided, digital program is designed to help adolescents develop study skills.

Primary outcomes

  1. Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 3-month Follow-Up

    Time frame: 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.

  2. Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 12-month Follow-Up

    Time frame: 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.

  3. Change in State Hope Scale Pathways Subscale From Immediately Pre-Intervention to Immediately Post-Intervention

    Time frame: 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.

  4. Change in Beck Hopelessness Scale From Immediately Pre-Intervention to Immediately Post-Intervention

    Time frame: 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.

Secondary outcomes

  1. Perceived Program Acceptability and Helpfulness

    Time frame: Immediately post-intervention

    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.

  2. Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 3-month Follow-Up

    Time frame: 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.

  3. Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 12-month Follow-Up

    Time frame: 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.

  4. Change in State Hope Scale From Baseline to 3-Month Follow-Up

    Time frame: 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.

  5. Change in State Hope Scale From Baseline to 12-Month Follow-Up

    Time frame: 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.

  6. Change in Beck Hopelessness Scale From Baseline to 3-Month Follow-Up

    Time frame: 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.

  7. Change in Beck Hopelessness Scale From Baseline to 12-Month Follow-Up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harvard University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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