HealthyNCT06896071
Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand
A study testing Project SOLVE and Project Success in people with Healthy, run by The University of Waikato at 1 site in New Zealand.
Trial summary
Currently, one in five rangatahi (young people) in Aotearoa report difficulty accessing support for their mental health concerns. This treatment gap has prompted academics and clinicians to consider whether online and/or school-based interventions can increase access to evidence-based mental health care. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Project SOLVE and Project Success
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNew Zealand
- Study dates
- 30 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any Year 9 student (ages 12-14 years old) at a participating school who provides assent.
Who cannot join
- Any Year 9 student (ages 12-14 years old) at a participating school who does not provide assent and/or whose parent/caregiver does not provided consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
St Peter's School Cambridge
Cambridge
Sandra Buchanan, +64 07 827 9899, sandra.buchanan@stpeters.school.nz
morgantblind@gmail.com
About this study
Official title: Project SOLVE and Rangatahi in Aotearoa: Evaluating a Digital Single-Session Intervention for Adolescent Mental Health in New Zealand Through a School-based Randomised Controlled Trial
Currently, one in five rangatahi (young people) in Aotearoa report difficulty accessing support for their mental health concerns. This treatment gap has prompted academics and clinicians to consider whether online and/or school-based interventions can increase access to evidence-based mental health care.
This research is a randomised controlled trial to evaluate the effectiveness of Project SOLVE, an online problem-solving intervention, compared to Project Success, an activity that teaches young people study skills. Underdeveloped problem-solving skills have been associated with varying presentations of mental distress, including depression, hopelessness, and suicidal ideation. This association has meant problem solving is often featured as a core component of therapeutic interventions, and strengthening problem solving skills has been shown to improve clinical outcomes in youth who experience mental health concerns.
For these reasons, the investigators hope that Project SOLVE will support the development of problem solving in rangatahi in Aotearoa and have a positive effect on their proximal and longitudinal mental health outcomes.
- Conditions
- Healthy
- Being tested
- Project SOLVE, Project Success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SOLVEBehavioural
Project SOLVE is a 30-minute self-guided online activity that includes an introduction to problem solving and which types of problems might be most appropriate for this skill; a description of how the brain facilitates problem solving; vignettes demonstrating how older adolescents have solved their problems; scientific evidence that problem solving can work; practice exercises; and activities to encourage the use of problem solving in daily life. The intervention teaches students how to solve problems via the "SOLVE" framework (i.e., Saying what the problem is; One goal to aim for; Listing some solutions; Voting for the best solution; Exploring what works).
Project SuccessBehavioural
Project Success is comparable to Project SOLVE in format and length (i.e., a 30 minute online, self-guided intervention) and teaches young people three strategies to reach their academic goals: how to take effective notes, how to break big assignments down into smaller tasks, and how to ask trusted others for help.
| Study group | Role | What they receive |
|---|---|---|
| Project SOLVE | Experimental | In this arm, participants will complete Project SOLVE. Receives: Behavioral: Project SOLVE |
| Project Success | Active comparator | In this arm, participants will complete Project Success. Receives: Behavioral: Project Success |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalising and externalising symptoms
Internalising and externalising symptoms will be measured using the Behaviour and Feelings Survey.
Measured: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Secondary outcomes (6)
Social Problem Solving Skills
Social problem solving will be measured by the Social Problem-Solving Inventory - Revised Short-Form.
Measured: Immediately pre-intervention and 12 weeks post-intervention
General Self-Efficacy
Self-efficacy will be measured using the General Self-Efficacy Scale.
Measured: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Hope
Hope will be measured using the Child Hope Scale.
Measured: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Hopelessness
Hopelessness will be measured using the Beck Hopelessness Scale - Shortened.
Measured: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Well-Being
Well-being will be measured using the World Health Organisation Well-Being Index.
Measured: Immediately pre-intervention and 12 weeks post-intervention
Educational Self-Efficacy
Educational self-efficacy will be measured using the Educational Self-Efficacy Scale.
Measured: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Waikato
- Sponsor type
- University, hospital or other
- Collaborators
- Whau Mental Health Foundation (New Zealand)
- Responsible party
- Sponsor
- Investigators
- Morgan T Blind, BA(Hon), Principal investigator, University of Waikato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896071
- Sponsor's protocol ID
- HREC(Health)2024#60
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fenwick-Smith A, Dahlberg EE, Thompson SC. Systematic review of resilience-enhancing, universal, primary school-based mental health promotion programs. BMC Psychol. 2018 Jul 5;6(1):30. doi: 10.1186/s40359-018-0242-3.
PubMed 29976252Thabrew H, Stasiak K, Hetrick SE, Wong S, Huss JH, Merry SN. E-Health interventions for anxiety and depression in children and adolescents with long-term physical conditions. Cochrane Database Syst Rev. 2018 Aug 15;8(8):CD012489. doi: 10.1002/14651858.CD012489.pub2.
PubMed 30110718Ludin N, Holt-Quick C, Hopkins S, Stasiak K, Hetrick S, Warren J, Cargo T. A Chatbot to Support Young People During the COVID-19 Pandemic in New Zealand: Evaluation of the Real-World Rollout of an Open Trial. J Med Internet Res. 2022 Nov 4;24(11):e38743. doi: 10.2196/38743.
PubMed 36219754Sutcliffe K, Ball J, Clark TC, Archer D, Peiris-John R, Crengle S, Fleming TT. Rapid and unequal decline in adolescent mental health and well-being 2012-2019: Findings from New Zealand cross-sectional surveys. Aust N Z J Psychiatry. 2023 Feb;57(2):264-282. doi: 10.1177/00048674221138503. Epub 2022 Dec 1.
PubMed 36453262Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.
PubMed 28117056Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.
PubMed 34887544
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SOLVE and Rangatahi in Aotearoa: Evaluating a Digital Single-Session Intervention for Adolescent Mental Health in New Zealand Through a School-based Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06896071
- Acronym / sponsor ID
- HREC(Health)2024#60
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of WaikatoUniversity, hospital or other
- Collaborators
- Whau Mental Health Foundation (New Zealand)
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
Currently, one in five rangatahi (young people) in Aotearoa report difficulty accessing support for their mental health concerns. This treatment gap has prompted academics and clinicians to consider whether online and/or school-based interventions can increase access to evidence-based mental health care.
This research is a randomised controlled trial to evaluate the effectiveness of Project SOLVE, an online problem-solving intervention, compared to Project Success, an activity that teaches young people study skills. Underdeveloped problem-solving skills have been associated with varying presentations of mental distress, including depression, hopelessness, and suicidal ideation. This association has meant problem solving is often featured as a core component of therapeutic interventions, and strengthening problem solving skills has been shown to improve clinical outcomes in youth who experience mental health concerns.
For these reasons, the investigators hope that Project SOLVE will support the development of problem solving in rangatahi in Aotearoa and have a positive effect on their proximal and longitudinal mental health outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project SOLVE | Experimental | Behavioral: Project SOLVEIn this arm, participants will complete Project SOLVE. |
| Project Success | Active comparator | Behavioral: Project SuccessIn this arm, participants will complete Project Success. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any Year 9 student (ages 12-14 years old) at a participating school who provides assent.
Key exclusion criteria (1 listed)
- Any Year 9 student (ages 12-14 years old) at a participating school who does not provide assent and/or whose parent/caregiver does not provided consent.
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 SOLVEProject SOLVE is a 30-minute self-guided online activity that includes an introduction to problem solving and which types of problems might be most appropriate for this skill; a description of how the brain facilitates problem solving; vignettes demonstrating how older adolescents have solved their problems; scientific evidence that problem solving can work; practice exercises; and activities to encourage the use of problem solving in daily life. The intervention teaches students how to solve problems via the "SOLVE" framework (i.e., Saying what the problem is; One goal to aim for; Listing some solutions; Voting for the best solution; Exploring what works). | Behavioural | Project SOLVE |
| Project SuccessProject Success is comparable to Project SOLVE in format and length (i.e., a 30 minute online, self-guided intervention) and teaches young people three strategies to reach their academic goals: how to take effective notes, how to break big assignments down into smaller tasks, and how to ask trusted others for help. | Behavioural | Project Success |
Primary outcome
Internalising and externalising symptoms
Time frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Internalising and externalising symptoms will be measured using the Behaviour and Feelings Survey.
6 secondary outcomes
Social Problem Solving Skills
Time frame: Immediately pre-intervention and 12 weeks post-intervention
General Self-Efficacy
Time frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Hope
Time frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Hopelessness
Time frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Well-Being
Time frame: Immediately pre-intervention and 12 weeks post-intervention
Educational Self-Efficacy
Time frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 29976252Fenwick-Smith A, Dahlberg EE, Thompson SC. Systematic review of resilience-enhancing, universal, primary school-based mental health promotion programs. BMC Psychol. 2018 Jul 5;6(1):30. doi: 10.1186/s40359-018-0242-3.
- Background: PubMed 30110718Thabrew H, Stasiak K, Hetrick SE, Wong S, Huss JH, Merry SN. E-Health interventions for anxiety and depression in children and adolescents with long-term physical conditions. Cochrane Database Syst Rev. 2018 Aug 15;8(8):CD012489. doi: 10.1002/14651858.CD012489.pub2.
- Background: PubMed 36219754Ludin N, Holt-Quick C, Hopkins S, Stasiak K, Hetrick S, Warren J, Cargo T. A Chatbot to Support Young People During the COVID-19 Pandemic in New Zealand: Evaluation of the Real-World Rollout of an Open Trial. J Med Internet Res. 2022 Nov 4;24(11):e38743. doi: 10.2196/38743.
- Background: PubMed 36453262Sutcliffe K, Ball J, Clark TC, Archer D, Peiris-John R, Crengle S, Fleming TT. Rapid and unequal decline in adolescent mental health and well-being 2012-2019: Findings from New Zealand cross-sectional surveys. Aust N Z J Psychiatry. 2023 Feb;57(2):264-282. doi: 10.1177/00048674221138503. Epub 2022 Dec 1.
- Background: PubMed 28117056Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.
- Background: PubMed 34887544Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.
- Individual participant dataSharing planned: Undecided
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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.
Morgan T Blind, BA(Hon) principal investigator
University of Waikato
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 Healthy, run by The University of Waikato at 1 site in New Zealand.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgan T Blind, BA(Hon) (+64 21 801 612, mb1080@students.waikato.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalising and externalising symptoms (time frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention). 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 NCT06896071, which also lists 6 linked publications.
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 26 Mar 2025.