- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06896071
Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Morgan T Blind, BA(Hon)
- Phone Number: +64 21 801 612
- Email: mb1080@students.waikato.ac.nz
Study Locations
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-
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Cambridge, New Zealand
- Recruiting
- St Peter's School Cambridge
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Contact:
- Sandra Buchanan
- Phone Number: +64 07 827 9899
- Email: sandra.buchanan@stpeters.school.nz
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Contact:
- Email: morgantblind@gmail.com
-
Contact:
- Morgan T Blind, BA(Hon)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Any Year 9 student (ages 12-14 years old) at a participating school who provides assent.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Project SOLVE
In this arm, participants will complete Project SOLVE.
|
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).
|
|
Active Comparator: Project Success
In this arm, participants will complete Project Success.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Problem Solving Skills
Time Frame: Immediately pre-intervention and 12 weeks post-intervention
|
Social problem solving will be measured by the Social Problem-Solving Inventory - Revised Short-Form.
|
Immediately pre-intervention and 12 weeks post-intervention
|
|
General Self-Efficacy
Time Frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
|
Self-efficacy will be measured using the General Self-Efficacy Scale.
|
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
|
Hope will be measured using the Child Hope Scale.
|
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
|
Hopelessness will be measured using the Beck Hopelessness Scale - Shortened.
|
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
|
|
Well-Being
Time Frame: Immediately pre-intervention and 12 weeks post-intervention
|
Well-being will be measured using the World Health Organisation Well-Being Index.
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Immediately pre-intervention and 12 weeks post-intervention
|
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Educational Self-Efficacy
Time Frame: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
|
Educational self-efficacy will be measured using the Educational Self-Efficacy Scale.
|
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Morgan T Blind, BA(Hon), University of Waikato
Publications and helpful links
General Publications
- Schleider 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.
- 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.
- Schleider 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.
- Thabrew 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.
- Ludin 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.
- Sutcliffe 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HREC(Health)2024#60
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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