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

NCT ID: NCT04806321

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-05-15

Brief Summary

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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

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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.

Conditions

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Anxiety Depression Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Project SOLVE

This program is self-guided, digital, and approximately 30 minutes in length. Content is designed to help adolescents solve, rather than be overwhelmed by, everyday problems. The program includes: (1) An introduction to problem solving; (2) Testimonials from "valued others" (older adolescents; celebrities) describing their use of problem solving skills; (3) Evidence from studies that our brains are capable of problem solving and that problem solving can be helpful; and (4) Activities designed to enable adolescents to practice sequential problem solving using a few steps (SOLVE Steps).

Group Type EXPERIMENTAL

Project SOLVE

Intervention Type OTHER

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

Project SUCCESS

This program is self-guided, digital, and approximately 30 minutes in length. Content is designed to help adolescents improve their study skills. This program includes: (1) An introduction to study skills; (2) Testimonials from "valued others" describing their use of study skills; (3) Description of helpful and commonly used study skills (e.g., note-taking); and (4) Activities designed to encourage adolescents to practice these skills in their daily lives.

Group Type ACTIVE_COMPARATOR

Project SUCCESS

Intervention Type OTHER

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

Interventions

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Project SOLVE

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

Intervention Type OTHER

Project SUCCESS

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard University

OTHER

Sponsor Role lead

Responsible Party

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Olivia Fitzpatrick

Principal Investigator; Doctoral Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Harvard University

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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Steinberg JS, Fitzpatrick OM, Khurana S, Kim MY, Mair P, Schleider JL, Hatzenbuehler ML, Weisz JR. Is There a Place for Cognitive Restructuring in Brief, Self-Guided Interventions? Randomized Controlled Trial of a Single-Session, Digital Program for Adolescents. J Clin Child Adolesc Psychol. 2024 Aug 9:1-21. doi: 10.1080/15374416.2024.2384026. Online ahead of print.

Reference Type DERIVED
PMID: 39120779 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB20-1791

Identifier Type: -

Identifier Source: org_study_id

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