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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
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Scientific title
An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents From a Community Impacted by March 15 Attacks: a Randomized Controlled Trial
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Secondary ID [1]
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RO#21178
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psychological Distress
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Trauma, Psychological
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Emotional Problem
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total problems score
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Assessment method [1]
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change in total problems score in Strengths and Difficulties Questionnaire (SDQ), self report and parent report.Scored 0-40 with higher scores indicating more problems.
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Timepoint [1]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Primary outcome [2]
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Emotional problems subscore
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Assessment method [2]
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change in emotional problems subscore in Strengths and Difficulties Questionnaire (SDQ), self report and parent report. Score ranges 0-10 with higher scores indicating more emotional difficulties.
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Timepoint [2]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Primary outcome [3]
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Trauma symptoms
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Assessment method [3]
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change in total score of Child Revised Impact of Event Score (8 item ) (CRIES-8) by self report, score range 0-40, higher scores indicate more PTSD symptoms.
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Timepoint [3]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Primary outcome [4]
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Somatic Symptom burden
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Assessment method [4]
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change in somatic symptoms measured using Somatic Symptom Scale (8-item) (SSS-8) self report questionnaire by participants and parents. 5 point Likert scale gives a total score with range 0-32. Cutoff scores identify individuals with low (4-7), medium (8-11), high(12-15), and very high (16-32)somatic symptom burden.
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Timepoint [4]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Primary outcome [5]
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Functional assessment
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Assessment method [5]
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change in function measured using Children's Global Assessment Scale (CGAS) by clinician. Clinicians give a single global score ranging from 0-100 with higher scores indicating better functioning.
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Timepoint [5]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Primary outcome [6]
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Time to recruitment
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Assessment method [6]
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Time in weeks required to enrol 16 participants and hold initial individual session.
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Timepoint [6]
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Measured before first group session at week 3.
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Primary outcome [7]
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Implementation
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Assessment method [7]
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measured by use of fidelity scale to rate adherence to planned session content
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Timepoint [7]
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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)
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Primary outcome [8]
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Psychological flexibility
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Assessment method [8]
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change in score on Acceptance and Action Questionnaire (AAQ-2), self
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Timepoint [8]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Primary outcome [9]
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Awareness of experience
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Assessment method [9]
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change in score on Awareness Indicator (AI), new measure asking about awareness of thoughts(aql), body sensations, feelings/emotions, and spiritual heart (qalb and ruh)
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Timepoint [9]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Secondary outcome [1]
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Parental distress
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Assessment method [1]
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change in distress measured using Kessler 10 (K-10) psychological questionnaire by parental self report and measured to identify whether further referrals are required. 5 point Likert scale gives a score of 10-50 with higher scores indicating higher distress. Scores 20-24 indicate likely mild mental disorder, 25-29 indicates likely moderate mental disorder and scores 30 and above indicate likely severe mental disorder. Referral will be offered for any scores over 20.
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Timepoint [1]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Secondary outcome [2]
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Suicidal risk
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Assessment method [2]
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measured using Ask Suicide-screening questionnaire by self-report to assess whether further intervention is necessary and for any deterioration in mental state.It has 4 screening questions and a positive response to any of the 4 questions indicates a positive screen.
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Timepoint [2]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Secondary outcome [3]
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Participant Wellbeing
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Assessment method [3]
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measured using the Child Outcome Rating Scale (CORS) by self report to check for any deterioration in wellbeing. The CORS is a 4 item visual analogue scale to give a quantitative measure of individual wellbeing, relationships, social role and overall wellbeing.
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Timepoint [3]
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at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).
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Secondary outcome [4]
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Personality traits
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Assessment method [4]
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change in specific traits of Extroversion, Neuroticism, Openness, Conscientiousness Agreeableness measured using the Big Five Inventory - 10 item (BFI-10) measure by self report. 10 questions are answered on a 5 point Likert scale giving a score for each personality trait.
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Timepoint [4]
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three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
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Secondary outcome [5]
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Attendance rates
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Assessment method [5]
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measured by recording attendance.
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Timepoint [5]
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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).
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Secondary outcome [6]
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Participant experience/acceptability
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Assessment method [6]
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measured by Child Session Rating Scale (CSRS) which uses a 4 item visual analogue scale to give a quantitative measure of acceptability. Qualitative feedback will also be collected.
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Timepoint [6]
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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.
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Secondary outcome [7]
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Retention
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Assessment method [7]
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measured by recording retention/drop-out rates.
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Timepoint [7]
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At final data collection point at week 19.
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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.
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Minimum age
12
Years
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Maximum age
19
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* active psychosis,
* severe substance use,
* intellectual disability
* non-English speaking young people.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Otago
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canterbury Medical Research Foundation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Otautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. This has had widespread repercussions in the Muslim and wider community in Christchurch and New Zealand. Uptake of a response pathway set up by community and district health board groups has been low despite reports of high levels of distress in the adolescent population. The proposed study offers a transdiagnostic group treatment approach (ie. Targeting a broad range of emotional difficulties) for teenagers from a community impacted by the March 15th shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic Psychology framework to address the local population's need. We will determine the feasibility and effectiveness of this approach in increasing wellbeing in teenagers. We will run gender-specific treatment groups (8 participants in each group) recruited from the community, with one individual session (for information and consent) and 6 group sessions. We will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, we will check in weekly with participants to monitor for any increased distress. We will also measure parental distress to explore whether an intervention for adolescents has an impact on parental wellbeing.
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Trial website
https://clinicaltrials.gov/study/NCT05030909
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Caroline Bell, MD
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Address
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University of Otago, Christchurch
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Katherine Donovan, BABMCh
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Address
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Country
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Phone
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+64 3 3726700
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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