Feasibility Study of a Group Intervention for Youth Wellbeing

NCT ID: NCT05030909

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2025-12-01

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.

Conditions

Psychological Distress; Trauma, Psychological; Emotional Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

transdiagnostic group treatment

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

transdiagnostic group treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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 Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canterbury Medical Research Foundation

UNKNOWN

Sponsor Role: collaborator

University of Otago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Bell, MD

Role: STUDY_DIRECTOR

University of Otago, Christchurch

Locations

Department of Psychological Medicine, University of Otago, Christchurch

Christchurch, Canterbury, New Zealand

Site Status: RECRUITING

Countries

New Zealand

Central Contacts

Katherine Donovan, BABMCh

Role: CONTACT

kat.donovan@otago.ac.nz

+64 3 3726700

Shaystah Dean

Role: CONTACT

shaystah.dean@otago.ac.nz

+64 3 3726700

Facility Contacts

Katherine Donovan, BABMCh

Role: primary

kat.donovan@otago.ac.nz

+64 3 3726700

Other Identifiers

RO#21178

Identifier Type: -

Identifier Source: org_study_id