Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000079842
Ethics application status
Approved
Date submitted
3/12/2020
Date registered
29/01/2021
Date last updated
16/02/2022
Date data sharing statement initially provided
29/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Tern Program: Development and Multi-site Evaluation of a Person-Centred, Trauma Informed Psychotherapy Protocol for Young People with Histories of Childhood Trauma
Scientific title
A Longitudinal Evaluation of a Semi-Structured, Multi-Component Psychosocial Treatment on Complex Post-traumatic Symptoms for Low SES Young People with Histories of Complex Trauma in Regional Queensland
Secondary ID [1] 302937 0
Nil known.
Universal Trial Number (UTN)
U1111-1262-2397
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Complex Posttraumatic Stress Disorder (cPTSD) 319963 0
PTSD 319964 0
Borderline Personality Disorder 319965 0
Condition category
Condition code
Mental Health 317898 317898 0 0
Other mental health disorders
Mental Health 317899 317899 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tern Program is a semi-structured, multi-component psychosocial intervention designed to address the features of Complex PTSD as defined by the ICD-11. The four major components of the program include: psychotherapy, a psychoeducation group, Limited Case Management, and Therapist Supports.

The Psychotherapy: This is an evidence-based psychotherapeutic model drawing from the current knowledge base. Intervention components include psychoeducation, cognitive therapy, somatic and affect regulation skills, behavioural activation, narrative and imaginal exposure, psychodynamic techniques, and supportive techniques such as problem-solving and coaching. This psychotherapy is semi-structured, with intervention components being delivered to greater or lesser extent as required by the patient. The psychotherapy is long-term (to a maximum of 24 months) in order to accommodate anticipated issues of engagement, ongoing or repeat traumatisation, and lapses in recovery (e.g. hospitalisation). Length of individual psychotherapy sessions will range from 50 - 90 minutes dependent on individual need.

The psychotherapy is broadly defined as including four distinct phases of care, with differing treatment components within each phase. These may loosely be described as follows:
Phase 1 - Safety and Coordination of Care (focus on engagement, assessment and environmental safety)
Phase 2 - Stabilisation (primary focus is on individual treatment and development of insight and coping skills)
Phase 3 - Processing (provision of exposure therapy to those requiring it)
Phase 4 - Identity and Independence (discharge phase focusing on occupational success, maintenance of recovery and consolidation of identity)

The psychotherapy will be delivered in weekly individual, one-on-one sessions for 24 months as required by individual participant needs. The treatment program will be individualised to each participant, which is required to be presented at a fortnightly case review. The individualised treatment plan must be presented after at least five sessions of intervention to allow sufficient assessment and treatment planning to have been completed. The treating therapist is then required to provide a minimum of one update on treatment planning after every 10 sessions of treatment (coinciding with the required assessment timepoints).


Psychoeducational Group: Participants in the program are invited to join a structured, five-week group program focused on providing education and coping skills regarding the biological and psychological impacts of trauma. This group may be completed prior to commencing individual psychotherapy or during the individual psychotherapy component.

Limited Case Management: This component refers to non-traditional psychotherapy tasks aimed at advocacy and improving the patient's environmental circumstances. This may include care-coordination, referral writing, stake-holder meetings, parent/family sessions, or advocacy within work or school settings.

Therapist Supports: In recognising the inherent challenges in working long-term with complex/severe mental health presentations, specific attention is provided to supporting the therapists delivering the Tern Program. Therapists received fortnightly two-hour group reflective supervision and access to regular training time and resources.

As the Tern Program is a new protocol, fidelity will be measured during the research project. Therapists will be required to record which treatment component they have delivered on a fidelity checklist for every session a patient receives. Fidelity will also be monitored through an assessment at the conclusion of a therapist's orientation to the program, and continually through the group supervision process.

Additionally, as the Tern Program is an active clinical service, participants will continue to receive services before and after the data collection period has ceased. If a participant continues to require treatment after the data collection timeframe, they will continue to receive it, though they will no longer be providing data to the project at that time. Participants will continue to be enrolled into the project until the final three months of data collection, so as to allow a minimum of two time points of data. No new participants will be invited to the research project past that point.
Intervention code [1] 319223 0
Treatment: Other
Comparator / control treatment
To complement this evaluation a waitlist control will be included as comparator. Pending an initial six months of data collection regarding Tern implementation and client outcomes, young people referred to Tern at the Townsville site but who are 1) not able to commence the program immediately and 2) not eligible for any other treatment service will be invited to be waitlist participants until they can commence Tern treatment. Waitlisted individuals will be contacted by the principal investigator by telephone and invited to attend a face-to-face appointment to complete informed consent. This will be followed by completion of their initial demographic survey and progress monitoring surveys. Consent processes and measures will be identical to those completed by active treatment recipients. Repeat measures will be completed at 10-weekly intervals to mimic the time required for 10 sessions of Tern. Once the young person is offered a place in Tern, their practitioner will assume ongoing data collection in place of the principal investigator.
This change was implemented after 10 participants had been enrolled.
Control group
Active

Outcomes
Primary outcome [1] 325912 0
Change in posttraumatic stress symptoms as measured by the PCL-5 (for >18s) or CATS (for <18s).
Timepoint [1] 325912 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.
Primary outcome [2] 325914 0
Change in degree of identity disturbance as measured by the Borderline Personality Disorder Checklist (BPD47).
Timepoint [2] 325914 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.
Primary outcome [3] 328965 0
Change in degree of emotional dysregulation as measured by the combination of the Mood, Impulsivity and Anger subscales of the BPD-47.
Timepoint [3] 328965 0
Entry and every 10 sessions of treatment and/or at treatment completion.
Secondary outcome [1] 389486 0
Change in frequency of dissociative symptoms as measured by the BPD-47.
Timepoint [1] 389486 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.
Secondary outcome [2] 389487 0
Change in Quality of Life scores as measured by the WHO-QoL (for >18s) or the Youth Quality of Life Short Form (YQOL-SF; for <18s).
Timepoint [2] 389487 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.
Secondary outcome [3] 389488 0
Change in the number of Emergency Department presentations for a mental health reason. Assessed by specifically designed demographic questionnaire.
Timepoint [3] 389488 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.
Secondary outcome [4] 389489 0
Change in number of hospitalisations for a mental health reason. Assessed by specifically designed demographic questionnaire.
Timepoint [4] 389489 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.
Secondary outcome [5] 389490 0
Change in the amount of occupational activity engaged in (be it volunteer, paid work or education). Assessed by specifically designed demographic questionnaire.
Timepoint [5] 389490 0
Entry, then after every 10 sessions of treatment and/or at treatment completion.

Eligibility
Key inclusion criteria
Young people aged 12-25 who present to headspace Townsville or headspace Mackay where the Tern Program operates. Young people may self-refer or be referred by other healthcare services.
Entry criteria requires evidence of childhood adversity and/or specific traumatic incidences occurring within the 0-25 age timeframe. This information will be assessed using the Revised ACE Questionnaire or clinical interview to identify events that occurred in the 19-25 age range .
Eligible participants must also be displaying symptoms consistent with posttraumatic stress, complex posttraumatic stress or personality disorder traits for entry into the Tern program.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of an intellectual impairment, or language impairment that may preclude completion of the required questionnaires.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The Tern Program is an active clinical service operating in regional Queensland. Sampling is convenience based on who presents or is referred to our service. Entry to the program is assessed through a standardised assessment process, then discussed by the principle investigator and the Tern team. Allocation to therapist is then deliberately determined by considering factors such as experience, competence, availability and interest of the therapist.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As noted above, sampling for this project is convenience based. Based on the staffing of the program and the projected 24 months of data collection, it is estimated that between 70-100 participants will be included during the research project.

It is the intention to conduct paired-samples T-tests to assess pre-post outcomes, and a series of regression analyses to determine strength of relationship between the various treatment and outcomes variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2021
Actual
9/07/2021
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
50
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 32137 0
4817 - Thuringowa Central
Recruitment postcode(s) [2] 32138 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 307358 0
University
Name [1] 307358 0
CQUniversity
Country [1] 307358 0
Australia
Funding source category [2] 307360 0
Commercial sector/Industry
Name [2] 307360 0
Northern Australia Primary Health Limited
Country [2] 307360 0
Australia
Funding source category [3] 307361 0
Government body
Name [3] 307361 0
North Queensland Primary Health Network (NQPHN)
Country [3] 307361 0
Australia
Primary sponsor type
University
Name
CQUniversity
Address
CQUniversity
538 Flinders St, Townsville QLD 4810
Country
Australia
Secondary sponsor category [1] 307999 0
Individual
Name [1] 307999 0
Mr Braden Dunn
Address [1] 307999 0
CQUniversity
538 Flinders St, Townsville QLD 4810
Country [1] 307999 0
Australia
Secondary sponsor category [2] 308002 0
Individual
Name [2] 308002 0
Dr Carol Keane
Address [2] 308002 0
CQUniversity
554-700 Yaamba Road, Norman Gardens 4701
Country [2] 308002 0
Australia
Secondary sponsor category [3] 308219 0
Individual
Name [3] 308219 0
Dr Jessica Paterson
Address [3] 308219 0
CQUniversity
44 Greenhill Road, Wayville SA 5034
Country [3] 308219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307444 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 307444 0
Ethics committee country [1] 307444 0
Australia
Date submitted for ethics approval [1] 307444 0
01/02/2021
Approval date [1] 307444 0
Ethics approval number [1] 307444 0
Ethics committee name [2] 309453 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [2] 309453 0
Ethics committee country [2] 309453 0
Australia
Date submitted for ethics approval [2] 309453 0
05/03/2021
Approval date [2] 309453 0
14/06/2021
Ethics approval number [2] 309453 0
0000022729

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107262 0
Mr Braden Dunn
Address 107262 0
CQUniversity Townsville
538 Flinders Street, Townsville QLD 4810
Country 107262 0
Australia
Phone 107262 0
+61 07 4799 1799
Fax 107262 0
Email 107262 0
[email protected]
Contact person for public queries
Name 107263 0
Braden Dunn
Address 107263 0
CQUniversity Townsville
538 Flinders Street, Townsville QLD 4810
Country 107263 0
Australia
Phone 107263 0
+61 07 4799 1799
Fax 107263 0
Email 107263 0
[email protected]
Contact person for scientific queries
Name 107264 0
Braden Dunn
Address 107264 0
CQUniversity Townsville
538 Flinders Street, Townsville QLD 4810
Country 107264 0
Australia
Phone 107264 0
+61 07 4799 1799
Fax 107264 0
Email 107264 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


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
SourceTitleYear of PublicationDOI
EmbaseThe Tern Programme Study protocol for an implementation trial of a flexible, long-term psychosocial intervention for complex posttraumatic stress in young people.2021https://dx.doi.org/10.1080/20008198.2021.1988479
N.B. These documents automatically identified may not have been verified by the study sponsor.