Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000056594
Ethics application status
Approved
Date submitted
26/10/2023
Date registered
23/01/2024
Date last updated
23/01/2024
Date data sharing statement initially provided
23/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a combined treatment for trauma and sleep in children
Scientific title
Integrated treatment of Cognitive Behaviour Therapy for Insomnia (CBT-i) and Trauma-Focused Cognitive Behaviour Therapy (TF-CBT) for posttraumatic stress and sleep disturbance in primary school aged children: A feasibility and initial proof of efficacy study
Secondary ID [1] 310819 0
Nil known
Universal Trial Number (UTN)
U1111-1299-2386
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder 331810 0
sleep disturbance 331811 0
Condition category
Condition code
Mental Health 328557 328557 0 0
Other mental health disorders
Neurological 329373 329373 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In an open trial, the study aims to test the feasibility and effectiveness of an integrated treatment for posttraumatic stress and sleep disturbance in primary school aged children.

Overview of study involvement:

Screening Questionnaire: Guardians will be asked to complete a brief set of questions about their child’s experience and how it has impacted them that will be used to assess whether their child is eligible to participate in the study. This will be completed over the phone with a psychologist when they first refer their child to the study. This part of the study will take approximately 30 minutes.

Pre-Treatment Assessment: One-week prior to treatment, children participating in the study and their guardian(s) will attend an interview at the Flinders University Sleep and Psychology Laboratory where there will be several questions to be filled out by children and their guardian(s) about reactions to the stressful event. Participants will also be given a sleep diary, a sleep monitoring wristwatch, and an under-mattress sleep sensor to track their child’s sleep for a week prior to treatment. The under-mattress sleep sensor is a set-and-forget measure can be left in place for the entire research study. It is estimated that the interview will take up to 90 minutes and the questionnaires will take up to 60 minutes.

Treatment: Children and their guardian(s) will be invited to attend 10 one-hour sessions at the Flinders University Sleep and Psychology Laboratory over 10 weeks. Children will initially receive 4 one-hour sessions of Cognitive Behaviour Therapy for Insomnia (CBT-i) to address sleep difficulties. CBT-i incorporates sleep scheduling changes, stimulus control, cognitive restructuring, psychoeducation, and relaxation techniques. At the completion of the 4 CBT-i sessions, guardian(s) will again complete a sleep diary for their child, and children will wear the sleep monitoring wristwatch to track their sleep for a week. Children will then receive 6 one-hour sessions of Trauma-Focused Cognitive Behaviour Therapy (TF-CBT) over 6 weeks to address posttraumatic stress. The first TF-CBT session will occur one week after the final CBT-i session. There are three phases of TF-CBT; 1) stabilization and skill building, 2) trauma narration and processing, and 3) integration and consolidation. Both CBTi and TF-CBT are recommended evidence-based treatments for sleep and posttraumatic stress, respectively.

Guardian Information Session: In the first few weeks of the study, guardian(s) will be invited to attend an hour-long online information session to help support them and their child throughout the treatment.

Post-Treatment Assessment: Children and their guardian(s) will complete a 30-minute interview and several questionnaires again to measure treatment outcomes. Guardian(s) will also complete a sleep diary for their child, and children will wear the sleep monitoring wristwatch again to track their sleep for a week. With permission, the under-mattress sensor will continue to track sleep up until the 3-month follow-up.

Three-Month Follow-Up Assessment: Children and the guardians will again complete a 30-minute interview, several questionnaires, and the sleep tracking via the sleep diary and wristwatch.

To ensure diagnostic reliability, all diagnostic interviews and therapy sessions will be video/audiotaped and will be coded by a research assistant to ensure that the therapist is adhering to the components of each treatment session. By adopting this design the proposed research conforms to the gold standard for conducting treatment outcome research with traumatised samples (Foa & Meadows, 1997), and ensures the methodological rigour of the proposed project. Assessors who have no knowledge of the participants or stage or treatment reached will be used at post and three-month follow up assessments.

Therapists involved are either registered psychologists or provisional psychologists who are currently undertaking clinical psychology training or have recently completed this training. All therapists will have training in the CBT-i and TF-CBT protocols. Therapists will receive weekly supervision from either Associate Professor Jessica Paterson or Professor Reg Nixon.
Intervention code [1] 327231 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336363 0
Change in PTSD symptom severity
Timepoint [1] 336363 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up
Primary outcome [2] 336364 0
Change in sleep efficiency
Timepoint [2] 336364 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up
Primary outcome [3] 336996 0
Change in PTSD symptom severity
Timepoint [3] 336996 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up
Secondary outcome [1] 428023 0
Change in behavioural sleep problems
Timepoint [1] 428023 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up
Secondary outcome [2] 428024 0
Change in quality of life
Timepoint [2] 428024 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up
Secondary outcome [3] 430342 0
Change in sleep-onset latency
Timepoint [3] 430342 0
The Withings sleep sensor will be used throughout the entire study duration (i.e., from the baseline assessment to the 3-month follow-up assessment).
Secondary outcome [4] 430343 0
Change in sleep duration
Timepoint [4] 430343 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up
Secondary outcome [5] 430344 0
Change in behavioural sleep problems
Timepoint [5] 430344 0
At baseline, Session 4, treatment completion (after completing Session 10), and 3-month post-treatment completion follow-up

Eligibility
Key inclusion criteria
All participants must endorse at least one potentially traumatic event with more than 4 weeks elapsed since exposure and must meet the cut-off for clinically relevant level of symptoms (ages 5-6: equal to or greater than 16; ages 7-12: equal to or greater than 21) on the Child and Adolescent Trauma Screen (CATS). In addition, participants must endorse the two sleep items (having bad dreams related to a stressful event, trouble falling or staying asleep) as having bothered the child in the last two weeks at least "half the time' or 'almost always'.

Guardian(s) must be willing to participate in the trial, and willing to travel to Flinders University’s Bedford Park campus for the initial assessment meeting, once per week for 10 weeks for treatment sessions, and again three months after the final treatment session for the follow-up assessment.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the study include currently accessing psychological or pharmacological treatment for posttraumatic stress or sleep disturbance, significant suicidal intent or risk of harm, diagnosis of a neurodevelopmental disorder as these are known to impact on sleep disturbance in complex ways that are outside the scope of the present study, significant psychiatric co-morbidity that precludes engagement in active therapy, moderate to severe traumatic brain injury or cognitive impairment, and ongoing trauma exposure (e.g., family violence).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed modeling (LMM) will be used for continuous data to determine treatment effects (i.e., pre-post and pre- to follow-up reductions) for both intent-to-treat and completer samples. For dichotomous outcomes (e.g., diagnostic outcomes), chi-square/Fishers Exact Test analyses will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/01/2024
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
16
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315061 0
Charities/Societies/Foundations
Name [1] 315061 0
Flinders Foundation (Health Seed Grant)
Country [1] 315061 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Education, Psychology and Social Work, Flinders University, GPO Box 2100, Adelaide 5001 South Australia
Country
Australia
Secondary sponsor category [1] 317086 0
None
Name [1] 317086 0
Address [1] 317086 0
Country [1] 317086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314014 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 314014 0
Ethics committee country [1] 314014 0
Australia
Date submitted for ethics approval [1] 314014 0
02/10/2023
Approval date [1] 314014 0
17/11/2023
Ethics approval number [1] 314014 0

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

Contacts
Principal investigator
Name 130122 0
A/Prof Jessica Paterson
Address 130122 0
College of Education, Psychology and Social Work, Flinders University, GPO Box 2100, Adelaide 5001 South Australia
Country 130122 0
Australia
Phone 130122 0
+61 08 8201 2324
Fax 130122 0
Email 130122 0
[email protected]
Contact person for public queries
Name 130123 0
Jessica Paterson
Address 130123 0
College of Education, Psychology and Social Work, Flinders University, GPO Box 2100, Adelaide 5001 South Australia
Country 130123 0
Australia
Phone 130123 0
+61 08 8201 2324
Fax 130123 0
Email 130123 0
[email protected]
Contact person for scientific queries
Name 130124 0
Jessica Paterson
Address 130124 0
College of Education, Psychology and Social Work, Flinders University, GPO Box 2100, Adelaide 5001 South Australia
Country 130124 0
Australia
Phone 130124 0
+61 08 8201 2324
Fax 130124 0
Email 130124 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
No additional documents have been identified.