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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06896071




Registration number
NCT06896071
Ethics application status
Date submitted
13/03/2025
Date registered
26/03/2025

Titles & IDs
Public title
Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand
Scientific 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
Secondary ID [1] 0 0
HREC(Health)2024#60
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Project SOLVE
BEHAVIORAL - Project Success

Experimental: Project SOLVE - In this arm, participants will complete Project SOLVE.

Active comparator: Project Success - In this arm, participants will complete Project Success.


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).

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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Internalising and externalising symptoms
Timepoint [1] 0 0
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Secondary outcome [1] 0 0
Social Problem Solving Skills
Timepoint [1] 0 0
Immediately pre-intervention and 12 weeks post-intervention
Secondary outcome [2] 0 0
General Self-Efficacy
Timepoint [2] 0 0
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Secondary outcome [3] 0 0
Hope
Timepoint [3] 0 0
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Secondary outcome [4] 0 0
Hopelessness
Timepoint [4] 0 0
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention
Secondary outcome [5] 0 0
Well-Being
Timepoint [5] 0 0
Immediately pre-intervention and 12 weeks post-intervention
Secondary outcome [6] 0 0
Educational Self-Efficacy
Timepoint [6] 0 0
Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention

Eligibility
Key inclusion criteria
* Any Year 9 student (ages 12-14 years old) at a participating school who provides assent.
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Waikato
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Whau Mental Health Foundation (New Zealand)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Morgan T Blind, BA(Hon)
Address 0 0
University of Waikato
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Morgan T Blind, BA(Hon)
Address 0 0
Country 0 0
Phone 0 0
+64 21 801 612
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06896071