Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand

March 19, 2025 updated by: The University of Waikato

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Project SOLVE
In this arm, participants will complete Project SOLVE.
Behavioral: 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.
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Immediately pre-intervention and 12 weeks post-intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Waikato

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Whau Mental Health Foundation (New Zealand)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Morgan T Blind, BA(Hon), University of Waikato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREC(Health)2024#60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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