CClinicalTrials.gg
CompletedNCT05030909Updated May 12, 2026

Feasibility Study of a Group Intervention for Youth Wellbeing

An interventional study of transdiagnostic group treatment in Psychological Distress, Trauma, Psychological and Emotional Problem, sponsored by University of Otago. Completed at 1 site in New Zealand. Open to participants aged 12 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University of Otago · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
12 Years to 19 Years
Sex
All
01

Study 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 Ōtautahi, 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.

Read the detailed description

Background and rationale On Friday 15 March 2019, two mosques in Christchurch were targeted in an act of terrorism. A white supremacist shooter attacked approximately 300 people, resulting in 51 deaths and 71 further people injured. The attack has been described as an attack on the Muslim faith and those affected by the event have expressed the importance of spiritual support as well as mental health support in the wake of the tragedy. Research into the effects of the attacks on adults in the Muslim community has identified significant concern over young people's mental health 1. A comprehensive framework of community support for children and adolescents was established involving collaboration between schools, primary care, community NGOs and secondary mental health services however the uptake of these services has been lower than expected despite reports of a growing need for support in these age groups1. Stigma regarding mental illness and distress has been identified as a major barrier to accessing supports.

Psychological distress, anxiety and depression are common in adolescence with substantial personal, societal and economic costs2,3. Transdiagnostic interventions (interventions which can be used across different mental health conditions) have gained support in treatment for adults, and evidence is emerging for their use in adolescent populations4-7. Evidence-informed holistic approaches to supporting wellbeing and mental health place less emphasis on pathology and can be more strengths-based with a focus on values. These approaches may appeal to young people and their families concerned about stigma and labelling 'difficulties' as 'disorders'.

Spiritually integrated psychotherapy has a growing evidence base and is associated with treatment adherence and therapeutic outcome8. An Islamic Psychology approach recognises spirituality as integral to the human experience, with models of Islamic psychotherapy gaining traction in recent years9. A model of traditionally integrated Islamic psychotherapy incorporates five interconnected elements; Áql (cognition), nafs (behavioural inclination), ruh (spirit), ihsas (emotion) and qalb (heart)10.

Holistic approaches to health are not new in New Zealand. Maori models of health are increasingly being adopted such as the Te Whare Tapa Wha model, emphasizing four cornerstones of Maori health11. These include Taha tinana (physical health), Taha wairua (spiritual health), Taha whanau (family health) and Taha hinengaro (mental health).

The proposed study offers a novel treatment approach for teenagers affected by the shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic psychology framework to address the local population's need. It will assess the likely size of treatment effect on reported emotional difficulties and post-traumatic stress symptoms, and the feasibility of this approach in supporting wellbeing. We also will measure parental distress (mental health difficulties and physical symptoms) to explore whether an intervention for adolescents has an impact on parental wellbeing. The programme will also provide the opportunity to screen and identify individuals who may benefit from referral to further supports.

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Conditions studied

  • Psychological Distress
  • Trauma, Psychological
  • Emotional Problem

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03

In context

Psychological Trauma

139 studies on the registry are indexed under Psychological Trauma; 41 are open to participants now.

This study's enrollment of 26 is below the median of 80 across 105 interventional studies indexed under Psychological Trauma.

Browse Psychological Trauma studies →

Lead sponsor

University of Otago is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Exclusion criteria

Exclusion Criteria:

  • active psychosis,
  • severe substance use,
  • intellectual disability
  • non-English speaking young people.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • 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.

    Behavioral: transdiagnostic group treatment

  • 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

Interventions

  • Behavioraltransdiagnostic 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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What researchers measure

Primary outcomes

  1. Total problems score

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  2. Emotional problems subscore

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  3. Trauma symptoms

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  4. Somatic Symptom burden

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  5. Functional assessment

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  6. Time to recruitment

    Time in weeks required to enrol 16 participants and hold initial individual session.

    Time frame: Measured before first group session at week 3.

  7. Implementation

    measured by use of fidelity scale to rate adherence to planned session content

    Time frame: 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)

  8. Psychological flexibility

    change in score on Acceptance and Action Questionnaire (AAQ-2), self

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  9. Awareness of experience

    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)

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

Secondary outcomes

  1. Parental distress

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  2. Suicidal risk

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  3. Participant Wellbeing

    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.

    Time frame: at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).

  4. Personality traits

    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.

    Time frame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).

  5. Attendance rates

    measured by recording attendance.

    Time frame: 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).

  6. Participant experience/acceptability

    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.

    Time frame: 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.

  7. Retention

    measured by recording retention/drop-out rates.

    Time frame: At final data collection point at week 19.

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Study locations

1 site
  • Department of Psychological Medicine, University of Otago, Christchurch
    Christchurch, Canterbury 8140, New Zealand
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05030909
Lead sponsor
University of Otago
Collaborators
Canterbury Medical Research Foundation
Responsible party
Sponsor
First posted
Sep 1, 2021
Start date
Apr 10, 2024
Primary completion
Sep 7, 2025
Completion
Sep 7, 2025
Last update
May 12, 2026

Study contacts

Caroline Bell, MD
study director · University of Otago, Christchurch

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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