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

NCT04806321 | Completed

• 1 other identifier: IRB20-1791
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Stress

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (7)

• Perceived Program Acceptability and Helpfulness

  Immediately post-intervention

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

  Baseline to 3-month follow-up

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

  Baseline to 12-month follow-up

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

  Baseline to 3-month follow-up

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

  Baseline to 12-month follow-up

Study Arms (2)

Project SOLVE

EXPERIMENTAL

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).

Other: Project SOLVE

Project SUCCESS

ACTIVE COMPARATOR

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.

Other: Project SUCCESS

Interventions

Project SOLVE OTHER

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

Project SOLVE

Project SUCCESS OTHER

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

Project SUCCESS

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• 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.

  PMID: 39120779 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Doctoral Student

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 19, 2021
• Study Start: March 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

US (1)