Feasibility Study of a Group Intervention for Youths Impacted by the March 15th Attacks

Sponsor
University of Otago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05030909
Collaborator
Canterbury District Health Board (Other)
16
1
1
5.1
3.1

Study Details

Study Description

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 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 broad range of emotional difficulties) for teenagers affected by the March 15th shootings, incorporating a faith-based element based on Islamic psychology to address the local population's need. Investigators will assess the feasibility of this approach and offer the opportunity to screen and identify individuals in need of more intensive intervention. Investigators will run two gender-specific treatment groups (8 participants each) recruited from the community, with one individual session (for information and consent) and 5 group sessions. Self-report questionnaires will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, participants will answer weekly brief measures to monitor for any increased distress.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: transdiagnostic group treatment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a pilot and feasibility study to assess the methods of recruitment, delivery (including the use of a treatment fidelity measure), and face validity and acceptability of a group psychological treatment.This is a pilot and feasibility study to assess the methods of recruitment, delivery (including the use of a treatment fidelity measure), and face validity and acceptability of a group psychological treatment.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents Impacted by March 15 Attacks: an Open-label Pilot and Feasibility Trial
Anticipated Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/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 5 group sessions. Both groups will receive the same intervention.

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.

Outcome Measures

Primary Outcome Measures

  1. Time to recruitment [Measured before first group session at week 3.]

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

  2. 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).]

    measured by recording attendance.

  3. Implementation [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)]

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

  4. Participant experience/acceptability [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.]

    measured by Child Session Rating Scale (CSRS) which uses a 4 item visual analogue scale to give a quantitative measure of acceptibility. Qualitatitive feedback will also be collected.

  5. Retention [At final data collection point at week 19.]

    measured by recording retention/drop-out rates.

Secondary Outcome Measures

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

    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.

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

    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.

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

    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.

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

    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.

  5. Participant Wellbeing [at each individual (week 1) and group session (weeks 3-7) and at 3 month follow up (week 19).]

    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.

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

    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.

  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).]

    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.

  8. 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).]

    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.

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

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All high school-enrolled teenagers who self-identify as being significantly psychologically affected by the mosque shootings

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychological Medicine, University of Otago, Christchurch Christchurch Canterbury New Zealand 8140

Sponsors and Collaborators

  • University of Otago
  • Canterbury District Health Board

Investigators

  • Study Director: Caroline Bell, MD, University of Otago, Christchurch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Otago
ClinicalTrials.gov Identifier:
NCT05030909
Other Study ID Numbers:
  • RO#21178
First Posted:
Sep 1, 2021
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021