Feasibility Study of a Group Intervention for Youths Impacted by the March 15th Attacks
Primary Purpose
Psychological Distress, Trauma, Psychological, Emotional Problem
Status
Suspended
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
transdiagnostic group treatment
Sponsored by
About this trial
This is an interventional health services research trial for Psychological Distress
Eligibility Criteria
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.
Sites / Locations
- Department of Psychological Medicine, University of Otago, Christchurch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
transdiagnostic group protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
Time to recruitment
Time in weeks required to enrol 16 participants and hold initial individual session.
Attendance rates
measured by recording attendance.
Implementation
measured by use of fidelity scale to rate adherence to planned session content
Participant experience/acceptability
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.
Retention
measured by recording retention/drop-out rates.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05030909
First Posted
August 9, 2021
Last Updated
November 2, 2022
Sponsor
University of Otago
Collaborators
Canterbury District Health Board
1. Study Identification
Unique Protocol Identification Number
NCT05030909
Brief Title
Feasibility Study of a Group Intervention for Youths Impacted by the March 15th Attacks
Official Title
An Integrated Transdiagnostic Protocol to Support Wellbeing in Adolescents Impacted by March 15 Attacks: an Open-label Pilot and Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Progress halted due to COVID situation and staffing challenges.
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Otago
Collaborators
Canterbury District Health Board
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress, Trauma, Psychological, Emotional Problem
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transdiagnostic group protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
transdiagnostic group treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to recruitment
Description
Time in weeks required to enrol 16 participants and hold initial individual session.
Time Frame
Measured before first group session at week 3.
Title
Attendance rates
Description
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).
Title
Implementation
Description
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)
Title
Participant experience/acceptability
Description
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.
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.
Title
Retention
Description
measured by recording retention/drop-out rates.
Time Frame
At final data collection point at week 19.
Secondary Outcome Measure Information:
Title
Total problems score
Description
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).
Title
Trauma symptoms
Description
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).
Title
Suicidal risk
Description
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).
Title
Personality traits
Description
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).
Title
Participant Wellbeing
Description
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).
Title
Functional assessment
Description
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).
Title
Parental distress
Description
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).
Title
Somatic Symptom burden
Description
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).
Title
Emotional problems subscore
Description
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).
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Bell, MD
Organizational Affiliation
University of Otago, Christchurch
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychological Medicine, University of Otago, Christchurch
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8140
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Study of a Group Intervention for Youths Impacted by the March 15th Attacks
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