Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000893909
Ethics application status
Approved
Date submitted
25/06/2020
Date registered
10/09/2020
Date last updated
15/10/2021
Date data sharing statement initially provided
10/09/2020
Type of registration
N/A

Titles & IDs
Public title
Intensive Trauma-Focused Cognitive Behavioural Therapy for the treatment of Post-Traumatic Stress Disorder (PTSD) in an acute adolescent mental health unit and 3-month follow-up
Scientific title
Intensive Trauma-Focused Cognitive Behavioural Therapy for the treatment of PTSD in an acute adolescent mental health unit and 3-month follow-up
Secondary ID [1] 301313 0
Nil known
Universal Trial Number (UTN)
U1111-1252-4024
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder (PTSD) 317518 0
Depression 318019 0
Suicidality 318020 0
Condition category
Condition code
Mental Health 315613 315613 0 0
Other mental health disorders
Mental Health 316044 316044 0 0
Depression
Mental Health 316045 316045 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trauma Focused Cognitive Behaviour Therapy (TF-CBT)
TF-CBT is a component based intervention typically utilised in community settings over a 12 to 16-week period with one session conducted per week. The components of TF-CBT are: Psychoeducation/Parenting Skills, Relaxation, Affective Modulation, Cognitive Coping, Trauma Narrative and In-vivo Exposure to decrease trauma reminders, Cognitive Processing, Conjoint Child-Parent sessions, and Enhancing Safety.

For this study, the young person will receive an intensive adaption: 3 1:1 TF-CBT sessions per week (for a total of 3 weeks) on the unit with the trained Clinical Psychologist whilst maintaining fidelity to the treatment components (i.e. 9 sessions for the young person).
Sessions will be one hour in length. Sessions will be conducted on the adolescent mental health unit. Adherence will be monitored with a TF-CBT fidelity checklist, to ensure that all principles of TFCBT treatment are met. 1 of these sessions with be a conjoint parent-child session for the purposes of sharing the trauma narrative - it occurs usually in week 3. An extra 1 hour session will be provided to a non-offending caregiver to provide parenting skills and assess parental reponses to the trauma in week 1.
Intervention code [1] 317618 0
Treatment: Other
Intervention code [2] 318321 0
Behaviour
Comparator / control treatment
Treatment as Usual
For the purposes of this study a standardised 9 session intervention model which is consistent with Trauma Informed Care principles will be implemented. The treatment involves: psychoeducation with adolescent, psychoeducation with caregiver, de-arousal skills, distress tolerance skills, and safety planning with young person and caregiver. Sessions will be commensurate with the TFCBT sessions in length and frequency, and matched for caregiver involvement (i.e. 1 conjoint parent-child session, and 1 extra 1 hour session for the parent or caregiver alone).

Three sessions will be held per week (one hour each) for a total of 3 weeks.

Treatment will be administered by the trained Clinical Psychologist in 1:1 sessions on the adolescent mental health unit during the young person’s admission
Control group
Active

Outcomes
Primary outcome [1] 323844 0
PTSD Symptoms (measured by change in Child and Adolescent Trauma Screen (CATS) score)
Timepoint [1] 323844 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)
Secondary outcome [1] 383038 0
Comorbid mental health such as depression and anxiety will be measured by change in Revised Children's Anxiety and Depression Scale (RCADS) score
Timepoint [1] 383038 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)
Secondary outcome [2] 383039 0
General health and social functioning will be measured by change in Health of the Nation Outcome Scales- Children and Adolescents (HONOSCA) score
Timepoint [2] 383039 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)
Secondary outcome [3] 383040 0
Longevity of intervention (as measured by number of re-presentations to emergency department as recorded in NSW Health electronic Medical Records (eMR))
Timepoint [3] 383040 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)
Secondary outcome [4] 383041 0
Suicidality (as measured by changes in Harkavy Asnis Suicide Survey (HASS)
Timepoint [4] 383041 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)
Secondary outcome [5] 385609 0
Emotional, social and behavioural functioning as measured by change in Strengths and Difficulties Questionnaire (SDQ).
Timepoint [5] 385609 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)
Secondary outcome [6] 385610 0
General functioning will be measured by change in Children's Global Assessment Scale (CGAS) score
Timepoint [6] 385610 0
Pre-Intervention (before allocation to intervention group)
Post-Intervention (in the 24-48 hours after completion of intervention)
3-month follow up (3-months following discharge from unit)

Eligibility
Key inclusion criteria
• Age range: 12-17, admitted to the Adolescent mental health unit during the study period
• Diagnosis: Meeting DSM 5 criteria for Post-Traumatic Stress Disorder, and PTSD being the primary diagnosis where co-morbid disorders are present
• Availability of a non-offending caregiver or parent to participate
• Willingness to give written informed consent and willingness to participate in and comply with the study.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Moderate to severe Intellectual Disability (according to screening of medical file/psychiatric history on admission)
• Co-morbid active Schizophrenia or active Hypomanic or Manic episode
• Unable to or unwilling to consent to participate (e.g. cognitive impairment, under Mental Health Act 2007)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be determined by an off-site investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be achieved using a computerised random-number sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The initial analysis will be a t-test comparing between groups. This analysis would have the power to detect a small effect size (d = 0.15-0.25) with power of ß = 0.8. The statistical analysis will involve a between-group repeated-measures (3x2) ANOVA examining differences between groups at each of the three study milestones, with the predicted sample size of 106, assuming a 0.5 correlation between variables. Between group t-tests will confirm differences in the main study variables (HoNOSCA, SDQ, CGAS, SIQ, RCADS).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16703 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 30302 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 305750 0
University
Name [1] 305750 0
UNSW
Country [1] 305750 0
Australia
Funding source category [2] 305757 0
Other Collaborative groups
Name [2] 305757 0
SPHERE Clinical Academic Group - SWSLHD Clinical Knowledge Exchange Seed Funding Initiative
Country [2] 305757 0
Australia
Primary sponsor type
Hospital
Name
Campbelltown Hospital
Address
Gna Ka Lun Adolescent Mental Health Unit
Campbelltown Hospital
Therry Road
CAMPBELLTOWN NSW 2560
Country
Australia
Secondary sponsor category [1] 306180 0
Other Collaborative groups
Name [1] 306180 0
The Ingham Institute
Address [1] 306180 0
1 Campbell St
Liverpool NSW 2170
Country [1] 306180 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306024 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306024 0
Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 306024 0
Australia
Date submitted for ethics approval [1] 306024 0
01/05/2020
Approval date [1] 306024 0
19/06/2020
Ethics approval number [1] 306024 0
2020/ETH00356

Summary
Brief summary
Primary: Explore the impact of intensive inpatient treatment on PTSD and co-morbidities on an inpatient population, when compared to treatment as usual.
Secondary: Determine if changes in outcomes are maintained at 3 month follow-up.
Ethical approval will be obtained from the Human Research Ethics Committee, SWSLHD. Adolescents meeting inclusion criteria of PTSD will be considered for the study. After informed consent is obtained, they will be randomly allocated to receive either intensive Trauma Focussed-Cognitive Behaviour Therapy (TF-CBT) intervention or Treatment As Usual (TAU) intervention. Once eligibility in study is confirmed the young person will be allocated a participant number to ensure anonymity. eMR audit will extract basic demographic and clinical data and scores on mandatory outcome measures.
Each participant will receive 9 sessions of allocated intervention. Following the end of treatment, the outcome measures will be completed again. Participants will then be contacted 3 months after treatment to complete outcome measures at follow up.
The fidelity of the TF-CBT treatment given will be monitored using the TF-CBT Fidelity Measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102458 0
Prof Valsamma Eapen
Address 102458 0
UNSW Medicine
Wallace Wurth Building
UNSW Sydney
18 High St
Kensington NSW 2052
Country 102458 0
Australia
Phone 102458 0
+612 9616 4245
Fax 102458 0
Email 102458 0
[email protected]
Contact person for public queries
Name 102459 0
Ms Nataile Cabrera
Address 102459 0
Gna Ka Lun Adolescent Mental Health Unit
Campbelltown Hospital
Therry Road
CAMPBELLTOWN NSW 2560
Country 102459 0
Australia
Phone 102459 0
+612 4634 4444
Fax 102459 0
Email 102459 0
[email protected]
Contact person for scientific queries
Name 102460 0
Dr Rajeev Jairam
Address 102460 0
Gna Ka Lun Adolescent Mental Health Unit
Campbelltown Hospital
Therry Road
CAMPBELLTOWN NSW 2560
Country 102460 0
Australia
Phone 102460 0
+612 4633 0950
Fax 102460 0
Email 102460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study involves participants under the age of 18 - individual participant data will not be made available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.