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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05030909




Registration number
NCT05030909
Ethics application status
Date submitted
9/08/2021
Date registered
1/09/2021

Titles & IDs
Public title
Feasibility Study of a Group Intervention for Youth Wellbeing
Scientific title
An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents From a Community Impacted by March 15 Attacks: a Randomized Controlled Trial
Secondary ID [1] 0 0
RO#21178
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 0 0
Trauma, Psychological 0 0
Emotional Problem 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - transdiagnostic group treatment

Experimental: transdiagnostic group protocol - The study will run two gender-specific treatment groups (8 participants each) recruited from the community, with one individual session (for information, consent and initial data collection) and 6 group sessions. Both groups will receive the same intervention. A second round of recruitment will run later with anticipated n of 32 in the experimental arm.

Other: Waitlist control - At both recruitment rounds, we will recruit 16 young people to receive the same intervention at a later stage. We will ask them to complete data collection at the same timepoints as the experimental arm participants to compare intervention effect size but will offer them the intervention afterwards so they still have access to the group. Data collected from them in the group will be used to assess feasibility and acceptability but not treatment effect size comparison.


BEHAVIORAL: transdiagnostic group treatment
The individual and group sessions will integrate core principles from Motivational interviewing (provide information, address barriers), Cognitive Behavioural Therapy (psychoeducation regarding emotions, enhancing emotional awareness, cognitive restructuring, behavioural experiments, relaxation) , Acceptance Commitment Therapy (mindfulness, grounding, emotional and body awareness, enhancing cognitive flexibility), and aspects of Islamic psychology.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total problems score
Timepoint [1] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Primary outcome [2] 0 0
Emotional problems subscore
Timepoint [2] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Primary outcome [3] 0 0
Trauma symptoms
Timepoint [3] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Primary outcome [4] 0 0
Somatic Symptom burden
Timepoint [4] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Primary outcome [5] 0 0
Functional assessment
Timepoint [5] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Primary outcome [6] 0 0
Time to recruitment
Timepoint [6] 0 0
Measured before first group session at week 3.
Primary outcome [7] 0 0
Implementation
Timepoint [7] 0 0
Each session will be audio-recorded and scored (at individual session at week 1, weekly group sessions weeks 3- 7, and 3 month follow up/week 19)
Primary outcome [8] 0 0
Psychological flexibility
Timepoint [8] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Primary outcome [9] 0 0
Awareness of experience
Timepoint [9] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Secondary outcome [1] 0 0
Parental distress
Timepoint [1] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Secondary outcome [2] 0 0
Suicidal risk
Timepoint [2] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Secondary outcome [3] 0 0
Participant Wellbeing
Timepoint [3] 0 0
at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).
Secondary outcome [4] 0 0
Personality traits
Timepoint [4] 0 0
three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Secondary outcome [5] 0 0
Attendance rates
Timepoint [5] 0 0
recorded at each weekly group session (weeks 3-7) and data collection point (at individual session at week 1, final group session at 7 weeks and 3 month follow up/week 19).
Secondary outcome [6] 0 0
Participant experience/acceptability
Timepoint [6] 0 0
After each individual (week 1) and weekly group session (weeks 3-7). A brief qualitative interview with each participant at the final group session at week 7 will also ask for their experience of the group.
Secondary outcome [7] 0 0
Retention
Timepoint [7] 0 0
At final data collection point at week 19.

Eligibility
Key inclusion criteria
* All high school enrolled teenagers
* English speaking
* Participants do not need to identify as Muslim but will be made aware that the protocol incorporates elements of the Muslim faith.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* active psychosis,
* severe substance use,
* intellectual disability
* non-English speaking young people.

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
Actual
10/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canterbury Medical Research Foundation
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
Caroline Bell, MD
Address 0 0
University of Otago, Christchurch
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katherine Donovan, BABMCh
Address 0 0
Country 0 0
Phone 0 0
+64 3 3726700
Fax 0 0
Email 0 0
kat.donovan@otago.ac.nz
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05030909