Clinical trial NCT05030909: Feasibility Study of a Group Intervention for Youth Wellbeing
Official title: An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents From a Community Impacted by March 15 Attacks: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Trauma, Psychological
Emotional Problem
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: Canterbury Medical Research Foundation
First posted: 2021-09-01
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial Design This is a randomised control trial with a sequential waitlist control design to measure treatment effect sizes on primary and secondary outcomes of participant and parental wellbeing. We also will assess the methods of delivery, face validity and acceptability of treatment. Teenagers (aged 12-19) from the community will be recruited and allocated randomly to either two gender-specific groups to receive the same intervention over 6 weeks or to a comparison group who will be offered the intervention later. This balances the need for control groups while also widening access to the intervention for recruited participants. The study will be community-based in one site (Ōtautahi, Christchurch, New Zealand), with an emphasis on widening access to mental health supports in a minority community by maintaining cultural sensitivity and reducing stigma associated with mental illness.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Total problems score
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Emotional problems subscore
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Trauma symptoms
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Somatic Symptom burden
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Functional assessment
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Time to recruitment
timeFrame: Measured before first group session at week 3.
measure: Implementation
timeFrame: 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)
measure: Psychological flexibility
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Awareness of experience
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
Secondary outcomes:
measure: Parental distress
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Suicidal risk
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Participant Wellbeing
timeFrame: at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).
measure: Personality traits
timeFrame: three time points - initial individual session at week 1, final group session at 7 weeks and 3 month follow up (week 19).
measure: Attendance rates
timeFrame: 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).
measure: Participant experience/acceptability
timeFrame: 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.
measure: Retention
timeFrame: At final data collection point at week 19.
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Department of Psychological Medicine, University of Otago, Christchurch
state: Canterbury
Study officials:
affiliation: University of Otago, Christchurch
name: Caroline Bell, MD
role: STUDY_DIRECTOR
References: