Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000971831
Ethics application status
Approved
Date submitted
7/05/2021
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
KIDS AID Treatment Trial: Transdiagnostic therapy for children who have experienced trauma and/or major stress
Scientific title
A pilot randomised controlled trial of the impact of a trauma informed version of the unified protocol for transdiagnostic treatment of emotional disorders on mental health symptoms in children
Secondary ID [1] 304172 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health problems associated with trauma 321863 0
Condition category
Condition code
Mental Health 319588 319588 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trauma informed unified protocol for transdiagnostic treatment of emotional disorders in children is a 15 session course following the traditional unified protocol approach (Kennedy et al., 2019) with some limited modifications to ensure the treatment is trauma informed, and therefore suitable for children who have experienced trauma. These modifications include the addition of trauma psychoeducation, clinician care to limit discussion of trauma in order to not traumatise or retraumatise children participating, addition of narrative trauma processing, clinician discretion on when to complete emotion exposure tasks, and individual therapy sessions rather than group format for children. Parent courses will continue to be run as groups.

UP-C is comprised of five core treatment principles, which together target difficulties in emotional regulation and reactivity across emotional disorders (see Kennedy et al., 2019 for more information).
1. Teaching emotional awareness skills
2. Teaching cognitive flexibility and linking thoughts to sensations skills
3. Challenging maladaptive threat appraisals and negative thinking using antecedent cognitive reappraisal
4. Teaching how to prevent emotional avoidance by developing and practicing awareness and mindfulness skills
5. Teaching how to identify and modify maladaptive action tendencies through behavioural activation and exposure.

For TI-UP-C the following modifications will be included:
1. Trauma psychoeducation within the emotional awareness component
2. Narrative trauma processing will be included in a graded fashion.
3. Exposure tasks will only take place as the client is ready, with extra sessions added if required to pace this.
4. A general trauma informed approach will be taken across all sessions, with care taken not to retraumatise the child. This will include clinicians developing a formulation of how the child's trauma experiences may impact their mental health, a graded approach to discussing the trauma, considering stimuli that may remind the child of their trauma and only discussing these in a graded fashion.
5. All sessions with the child included will be on an individual basis (child and parent with clinician). Parental sessions will still be run as a group.

Sessions will be 60 min with the child while parents attend a 60 minute group (2-4 parents). There is also 30 minutes of parent and child work at the end, so 90 minutes in total.

Sessions will run once weekly for 15 weeks.

The content of the parent sessions mirrors what children are learning in their individual sessions, and includes techniques parents can use to support children with these skills (e.g., how to help them practice a skill at home). Parent groups will be run in person, with two clinicians taking the group. Parent groups will consist of at least 2 parents and no more than 6 parents.

Adherence to the intervention will be measured in two ways. Sessions with children and parents will be videoed to ensure treatment fidelity. Fidelity to treatment will be assessed by randomly selecting 20% of treatment sessions from each condition, and coding these for adherence using two raters. 50% of these will be double rated to establish inter-rater reliability. Videos will be rated as (0=skill not covered, 1=skill covered). Session fidelity will also be monitored by clinician ratings of topics covered in each session, they will tick which treatment tasks they completed on session fidelity forms.
Intervention code [1] 320499 0
Treatment: Other
Comparator / control treatment
The control group will receive treatment as usual. This is defined as the standard treatment a child would receive at the psychology clinic where the study is being housed, where they see a psychologist for support with their mental health.
Control group
Active

Outcomes
Primary outcome [1] 327448 0
Change in trauma related mental health symptoms (as measured by SCARED)
Timepoint [1] 327448 0
Baseline, mid-intervention (Session 8), post completion of the intervention, 6 months follow-up and 12 months follow-up.
Primary outcome [2] 327449 0
Change in anxiety symptoms (Measured by the child behaviour checklist)
Timepoint [2] 327449 0
Baseline, mid-intervention (Session 8), post completion of the intervention, 6 months follow-up and 12 months follow-up.
Primary outcome [3] 327450 0
Change in depression symptoms (Measured by the child behaviour checklist)
Timepoint [3] 327450 0
Baseline, mid-intervention (Session 8), post completion of the intervention, 6 months follow-up and 12 months follow-up.
Secondary outcome [1] 395152 0
Psychotic like experiences (Measured by the Prodromal Questionnaire- Breif)
Timepoint [1] 395152 0
Baseline, mid-intervention (Session 8), post-completion of the intervention, 6 months follow-up and 12 months follow-up.
Secondary outcome [2] 395153 0
Suicide Ideation and Behaviour (Measured by the KSADS)
Timepoint [2] 395153 0
Baseline, mid-intervention (Session 8), post-completion of the intervention, 6 months follow-up and 12 months follow-up.
Secondary outcome [3] 395154 0
Emotion regulation (Measured by the Childhood Emotion Regulation Questionnaire)
Timepoint [3] 395154 0
Baseline, mid-intervention (Session 8), post-completion of the intervention, 6 months follow-up and 12 months follow-up.
Secondary outcome [4] 395155 0
Stress sensitivity (Measured by the Perceived Stress Scale for Children)
Timepoint [4] 395155 0
Baseline, mid-intervention (Session 8), post-completion of the intervention, 6 months follow-up and 12 months follow-up.
Secondary outcome [5] 395156 0
Threat detection: Measured by a study specific tool where children rate how likely negative events are (as completed in the Probability and Cost Questionnaire). Negative events were chosen from the Probability and Cost Questionnaire, the Outcome Probability Questionnaire, the Outcome Cost Questionnaire and the Coddington Life Events Questionnaire.
Timepoint [5] 395156 0
Baseline, mid-intervention (Session 8), post-completion of the intervention, 6 months follow-up and 12 months follow-up.
Secondary outcome [6] 395157 0
Acceptability of the treatment to children and parents. Measured by session rating scales (Child Outcome Rating Scale), and study specific questions at the end of therapy.
Timepoint [6] 395157 0
Weekly during treatment and post intervention (at the completion of their last session).

Eligibility
Key inclusion criteria
Participants will be required to have a history of at least one traumatic event as measured by the Child Adolescent Trauma Scale and/or at least one stressful life event measured by the Coddington Negative Life Events Scale, and elevated mental health symptoms (as indicated by a score in the clinical range on the Child Behavior Checklist) suspected to have occurred or increased following the trauma or stressful life event (measured by clinical interview). Participants need to speak sufficient English.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are experiencing severe PTSD (as measured by the KSADS), severe suicidal ideation or self-harming behaviour, have a psychotic disorder (as measured by the KSADS), have diagnosed or suspected Autism Spectrum Disorder, or have a suspected IQ <70 are not eligible. Participants who have received CBT in the past are also ineligible.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Power Calculation
As suggested by Whitehead et al., (2016), for a main trial designed with 90% power and two-sided 5% significance, they recommend pilot trial sample sizes per treatment arm of 15 for standardised effect sizes that are medium (0.5), and 10 for standard effect sizes that are large (0.8). As such, we will aim for a sample size of 12 children per condition, with ongoing recruitment to make up for drop-outs.

Study hypotheses will be examined using hierarchical linear modelling. Hierarchical linear modelling is ideal for these questions as it accounts for inter-person variance in data taken over multiple time points. It is also able robust to missing data (such as data from drop out or missed sessions).
Dependent variables will include mental health symptoms, mechanisms (stress sensitivity, emotion regulation) and treatment acceptability. Independent variables will include datapoint (pre, post, 6 mo and 12 mo), demographic variables, and treatment type (binomial: treatment as usual vs TI-UP-C).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308551 0
Other
Name [1] 308551 0
ISN Innovations
Country [1] 308551 0
Australia
Primary sponsor type
Individual
Name
Rebecca Grattan
Address
443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country
Australia
Secondary sponsor category [1] 309401 0
None
Name [1] 309401 0
Address [1] 309401 0
Country [1] 309401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308495 0
ISN Human Research Ethics Committee
Ethics committee address [1] 308495 0
443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Ethics committee country [1] 308495 0
Australia
Date submitted for ethics approval [1] 308495 0
04/05/2021
Approval date [1] 308495 0
07/07/2021
Ethics approval number [1] 308495 0
HREC Reference number: 210501

Summary
Brief summary
Present trauma interventions are limited in that they tend to be designed for children diagnosed with PTSD. This study aims to test an intervention that is suitable for children who have experienced trauma but are experiencing a wide range of symptoms. We want to see whether this treatment is acceptable to children and their parents, whether it is effective at reducing mental health symptoms, and whether it prevents future difficulties associated with trauma such as suicide and psychosis symptoms. We are also interested in what mechanisms the treatment may work through (e.g., emotion regulation).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110902 0
Dr Rebecca Grattan
Address 110902 0
Institute of Social Neuroscience, 443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country 110902 0
Australia
Phone 110902 0
+61 3 90081622
Fax 110902 0
Email 110902 0
[email protected]
Contact person for public queries
Name 110903 0
Dr Rebecca Grattan
Address 110903 0
Institute of Social Neuroscience, 443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country 110903 0
Australia
Phone 110903 0
+61 3 90081622
Fax 110903 0
Email 110903 0
[email protected]
Contact person for scientific queries
Name 110904 0
Dr Rebecca Grattan
Address 110904 0
Institute of Social Neuroscience, 443 Upper Heidelberg Rd, Ivanhoe VIC 3081
Country 110904 0
Australia
Phone 110904 0
+61 3 90081622
Fax 110904 0
Email 110904 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
Data collected as part of this study will be sensitive, clinical information related to traumatic experiences that includes video recordings. It is possible some of the data is specific enough that participants could be identified, and thus pose a risk to participants (e.g., from reporting child abuse).


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.