AnxietyNCT04806321
Project SOLVE: Trial of a Brief Digital Problem-solving Intervention
A study testing Project SOLVE and Project SUCCESS in people with Anxiety and Depression, run by Harvard University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- Project SOLVE and Project SUCCESS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project SOLVE: A School-based Trial of a Universal Single-session Digital Problem-solving Intervention for Adolescent Mental Health
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.
Read the 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.
- Conditions
- Anxiety, Depression, Stress
- Being tested
- Project SOLVE, Project SUCCESS
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SOLVEOther
This 30-minute, self-guided, digital program is designed to help adolescents solve, rather than be overwhelmed by, everyday problems.
Project SUCCESSOther
This 30-minute, self-guided, digital program is designed to help adolescents develop study skills.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Project SUCCESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately pre-intervention to immediately post-intervention
Secondary outcomes (7)
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.
Measured: Immediately post-intervention
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.
Measured: Baseline to 3-month follow-up
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.
Measured: Baseline to 12-month follow-up
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.
Measured: Baseline to 3-month follow-up
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.
Measured: Baseline to 12-month follow-up
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.
Measured: Baseline to 3-month follow-up
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.
Measured: Baseline to 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start15 Mar 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia Fitzpatrick, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806321
- Sponsor's protocol ID
- IRB20-1791
- Status last verified
- Jul 2022
- First submitted
- 8 Mar 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Analytic code will be made available upon publication of trial results. Study protocol and SAP are available with this registration submission.
Publications
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.
PubMed 39120779
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SOLVE: A School-based Trial of a Universal Single-session Digital Problem-solving Intervention for Adolescent Mental Health
- ClinicalTrials.gov ID
- NCT04806321
- Acronym / sponsor ID
- IRB20-1791
- Conditions
- Anxiety, Depression, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Project SOLVE | Experimental | Other: Project SOLVEThis 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). |
| Project SUCCESS | Active comparator | Other: Project SUCCESSThis 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project SOLVEThis 30-minute, self-guided, digital program is designed to help adolescents solve, rather than be overwhelmed by, everyday problems. | Other | Project SOLVE |
| Project SUCCESSThis 30-minute, self-guided, digital program is designed to help adolescents develop study skills. | Other | Project SUCCESS |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Perceived Program Acceptability and Helpfulness
Time frame: Immediately post-intervention
Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 3-month Follow-Up
Time frame: Baseline to 3-month follow-up
Change in Behavior and Feelings Survey (Externalizing Subscale) From Baseline to 12-month Follow-Up
Time frame: Baseline to 12-month follow-up
Change in State Hope Scale From Baseline to 3-Month Follow-Up
Time frame: Baseline to 3-month follow-up
Change in State Hope Scale From Baseline to 12-Month Follow-Up
Time frame: Baseline to 12-month follow-up
Change in Beck Hopelessness Scale From Baseline to 3-Month Follow-Up
Time frame: Baseline to 3-month follow-up
Change in Beck Hopelessness Scale From Baseline to 12-Month Follow-Up
Time frame: Baseline to 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 39120779Steinberg 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.
- Individual participant dataSharing planned: Undecided. Analytic code will be made available upon publication of trial results. Study protocol and SAP are available with this registration submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project SOLVE and Project SUCCESS in people with Anxiety and Depression, run by Harvard University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavior and Feelings Survey (Internalizing Subscale) From Baseline to 3-month Follow-Up (time frame: Baseline to 3-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.