Feasibility Study of a Group Intervention for Youth Wellbeing

NCT05030909 | Recruiting DMC

• 1 other identifier: RO#21178
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Trauma, Psychological; Emotional Problem

Outcome Measures

Primary Outcomes (9)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Time to recruitment

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

  Measured before first group session at week 3.

• Implementation

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

  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)

• Psychological flexibility

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

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

• 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)

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

Secondary Outcomes (7)

• Parental distress

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

• Suicidal risk

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

• Participant Wellbeing

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

• Personality traits

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

• Attendance rates

  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).

Study Arms (2)

transdiagnostic group protocol

EXPERIMENTAL

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

Waitlist control

OTHER

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

transdiagnostic group treatment 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; transdiagnostic group protocol

Eligibility Criteria

• Age: 12 Years - 19 Years
• Gender Eligibility Details: There will be two gender-specific groups. Participants will be able to choose which group they identify with (boy or girl). This is to increase acceptability within the Muslim culture.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Otago: lead
• Canterbury Medical Research Foundation: collaborator

Study Sites (1)

Department of Psychological Medicine, University of Otago, Christchurch

Christchurch, Canterbury, 8140, New Zealand

RECRUITING

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Caroline Bell, MD

  University of Otago, Christchurch

  STUDY DIRECTOR

Central Study Contacts

Katherine Donovan, BABMCh

CONTACT

+64 3 3726700; kat.donovan@otago.ac.nz

Shaystah Dean

CONTACT

+64 3 3726700; shaystah.dean@otago.ac.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 1, 2021
• Study Start: April 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)