Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000114549p
Ethics application status
Submitted, not yet approved
Date submitted
19/12/2023
Date registered
8/02/2024
Date last updated
11/08/2024
Date data sharing statement initially provided
8/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping young people with chronic medical conditions experiencing anxiety and depression
Scientific title
A waitlist randomised control trial assessing the efficacy of the Unified Protocol for the Treatment of Emotional Disorders in children and adolescents with chronic medical conditions who experience depression and anxiety
Secondary ID [1] 308423 0
Nil known
Universal Trial Number (UTN)
U1111-1285-0860
Trial acronym
UP-CAM (Unified Protocol for Children and Adolescents with Medical illness/condition)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic medical conditions (e.g., asthma) 328225 0
Mental health (anxiety) 328226 0
Mental health (depression) 332594 0
Condition category
Condition code
Mental Health 325274 325274 0 0
Anxiety
Mental Health 325275 325275 0 0
Depression
Mental Health 325276 325276 0 0
Other mental health disorders
Metabolic and Endocrine 329288 329288 0 0
Diabetes
Neurological 329290 329290 0 0
Epilepsy
Neurological 329291 329291 0 0
Multiple sclerosis
Inflammatory and Immune System 329292 329292 0 0
Autoimmune diseases
Inflammatory and Immune System 329293 329293 0 0
Rheumatoid arthritis
Respiratory 329294 329294 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to adapt and test the feasibility, acceptability, appropriateness, and efficacy of a transdiagnostic intervention called Unified Protocol for the Treatment of Emotional Disorders in Children and Adolescents (UP-C/A), to reduce anxiety and depression in children and adolescents with a chronic mental conditions.

The UP-C/A is a transdiagnostic intervention program adapted from the original version for adults. Using a manualised program, it targets underlying factors that are common to many emotional disorders, thereby addressing the primary emotional disorder, as well as comorbid emotional disorders.

It is a child-focused program based in cognitive behavioural therapy and incorporates mindfulness, flexible thinking, avoidance, interoceptive and situational experiences. The program also includes a parent treatment component which focus on teaching parents anxiety management strategies, reinforcement skills, and plan for at-home exposures.

In consultation with young people with lived experience of chronic medical conditions and emotional disorders, we will be adapting the lead characters in the UP-A/C program to feature characters that have a chronic medical condition to ensure that the program is relatable and developmentally appropriate. This lived experience group will be engaged as a first step of the study, and prior to the commencement of participant recruitment. The group will include four children (8-11 years), four adolescents (15 - 20 years) with a chronic medical condition who present with depression and/or anxiety as well as three parents who have children living with chronic medical conditions and depression and/or anxiety, and three adults (18 - 40 years) with lived experience of chronic medical conditions in childhood. They will be selected through a formal invitation process organised via the Royal Children’s Hospital Clinical Psychology Service (RCH Lived Experience Network) and will be invited to contribute to the design of the study, and interpretation of results.

Lived experience group members will have the options of providing their feedback either in group workshop sessions or in one-on-one call sessions (audio or video calls), depending on their preference. The first feedback/workshop session will focus on soliciting feedback on the study design (e.g., length of assessments) and the adapted version of the UP-C/A. A follow-up workshop is scheduled to take place within two to four weeks, where participants will receive updates on how their feedback has been integrated into the study design. Each of these two workshops/feedback sessions will last about 90 minutes (for the adults and parent groups), 60 minutes (for the adolescent group,), and 30 minutes for younger children. To address the power imbalance and make the lived experience group feel comfortable to provide feedback we have designed this information gathering in the following way. We will invite a member of the RCH Lived Experience Network to serve as a group facilitator and we will have this person review the study methods before we start recruitment the lived experience group members.

We will also consult clinicians (e.g., psychologists) working with young people with chronic medical conditions to get their feedback during the UP-C/A adaptation process. This feedback session will be in a form of a workshop, where clinicians will learn about the UP-C/A program, learn about the proposed program adaptations and the research design, and will be asked to provide their feedback on how they think the adapted program can be better tailored for this target group.

The feedback gathered from these sessions will be incorporated in the study design and submitted as an ethics amendment to the Royal Children's Hospital Human ethics Committee prior to commencing data collection for this study. Recruitment of study participants will commence following ethics approval

Study participants between 8 – 11 years and 12 – 17.11 years will receive the child (UP-C) and adolescent (UP-A) versions of the intervention, respectively. These are two separate versions of the UP-C/A intervention and selection of appropriate version will be based on each individual child's age. The child version (UP-C) includes 15 sessions with corresponding parent components for each session. Parents are required to attend each session to learn the skills their child is learning so they are equipped to support their child. It is divided into five modules or CLUES skills - “Consider How I Feel”, “Look at My Thoughts”, “Use Detective Thinking and Problem Solving”, “Experience My Emotions”, and “Stay Healthy and Happy”. The adolescent version (UP-A) comprises eight core modules (five core and three supplementary modules), including modules on emotion-focused education, awareness techniques, cognitive strategies, and problem-solving. The adolescent version has an optional parent module (on parenting the emotional adolescents). The UP-C/A modules are designed to be flexible in length to accommodate patient heterogeneity. Most therapy sessions will last for about 50 minutes, but there will be flexibility to ensure that each child's unique needs are catered for.

Therapy sessions with each participant will be completed weekly, up to a maximum of 6 months, including 3 to 21 sessions, depending on the individual needs of the client. Sessions will be administered both face to face and online (via RCH telehealth). Participants will be required to attend a minimum of three face-to-face sessions and the remaining can be either face-to-face or online.

The intervention will be delivered by Psychologists with certification from the Australian Health Practitioner Regulation Agency, who will complete training from a highly experienced UP-A/C therapist prior to delivering the intervention.

The study will include a total of 60 children/adolescents, with 30 participants receiving the UP-A/C program immediately upon enrolling in the study. The other 30 participants will be assigned to a waitlist control group and will only receive the UP-A/C intervention 8 weeks after enrolling in the study. Participants will be recruited from the Royal Children's Hospital Clinical Clinical Psychology Service (Australia), when they attend the clinic for psychological assessment.

To assess the psychologist’s adherence to the treatment protocol, the psychologists will participate in fortnightly clinical supervision either in-person or via teleconference with a Senior Psychologist trained in the UP-C/A. A member of the UP-A/C development team will also be consulted for supervision and advice on the administration protocol as and when needed. Ten percent (10%) of therapy sessions will be recorded (with participant and parental permission) and will be reviewed/rated by the Research Coordinator to ensure the program is adhered to. A study-developed checklist will be used to evaluate each therapy session, and the entries will be scored to provide a quantitative measure of treatment fidelity.
Intervention code [1] 324875 0
Behaviour
Comparator / control treatment
During the waitlist period, the waitlist control group will be monitored fortnightly by a clinician via telephone check-ins. It is anticipated that having a clinician conduct these check-ins can limit risk of missing any clinically concerning incidents in participants during the waitlist. Any concerns (i.e., mental health or risk-related) will be flagged with a designated clinical psychologist at the RCH Clinical Psychology Service. In case a waitlist participant requires significant mental health intervention during the waiting period, our team will support them to get the help needed, either within or outside the RCH, and they will no longer be included waitlist control group.
Control group
Active

Outcomes
Primary outcome [1] 333134 0
Outcome: Depression
Measure: Depression subscale on the Revised Child Anxiety and Depression Scale (RCADS).

This study will primarily assess the extent of change in depression symptoms in the intervention vs waitlist control groups. Change will be evaluated within and between groups, across timepoints, using the self and parent-rated scores on the RCADS.
Timepoint [1] 333134 0
The RCADS will be administered at all timepoints:

T1 - Baseline
T2 - 8 weeks into the intervention
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Primary outcome [2] 337113 0
Outcome: Anxiety
Measure: Anxiety subscale on the Revised Child Anxiety and Depression Scale (RCADS).

This study will primarily assess the extent of change in anxiety symptoms in the intervention vs waitlist control groups. Change will be evaluated within and between groups, across timepoints, using the self and parent-rated scores on the RCADS.
Timepoint [2] 337113 0
The RCADS will be administered at all timepoints:

T1 - Baseline
T2 - 8 weeks into the intervention
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Secondary outcome [1] 415911 0
Outcome: Self-Worth
Measure: The Harter Self Perception Measure (HSPM)
Timepoint [1] 415911 0
T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Secondary outcome [2] 415914 0
Outcome: Adaptive behaviour
Measure: Adaptive Behaviour Assessment Systems
Timepoint [2] 415914 0
T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Secondary outcome [3] 419292 0
Outcome: Health-related quality of life
Measure: Child Health Utility- 9D ( CHU-9D)
Timepoint [3] 419292 0
T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Secondary outcome [4] 419293 0
Outcome: Sleep
Measure: Sleep Disturbance Scale for Children
Timepoint [4] 419293 0
T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Secondary outcome [5] 419298 0
Outcome: Intervention feasibility Measures:
- Feasibility, Acceptability, Appropriateness Questionnaire
Timepoint [5] 419298 0
T1 - Baseline
T2 - 3 months into the intervention
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion
Secondary outcome [6] 430765 0
Outcome: Intervention feasibility Measures:
- Study-designed feasibility questionnaire
Timepoint [6] 430765 0
T1 - Baseline
T2 - 3 months into the intervention
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion

Eligibility
Key inclusion criteria
Inclusion criteria are as follows:

a. Have a CMC, defined as any medical condition where the child/adolescent have regular appointments or is seen every 6 months, and has emotional symptoms associated with their medical condition or impacting their medical condition (e.g., treatment adherence). Examples of CMC include asthma, congenital heart disease, diabetes, epilepsy, inflammatory bowel disease, juvenile idiopathic arthritis, and sickle cell disease.

b. Score above the high-risk clinical range (greater than or equal to 65) for any of the subscales on the Revised Child Anxiety and Depression Scale (RCADS), to indicate clinically concerning levels of depression and anxiety. This will be based on both parent-report and self-reported outcomes on the RCADS.

c. Young person and one parent will need to have sufficient English to complete the protocol without an interpreter. This is because most of the measures used in the project are only available in the English language, and the UP-C/A has not been validated in other languages.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are as follows:

a. Children/adolescents with a CMC where significant medical deterioration is expected and children in palliative care. Rationale: Most children within this high-risk group may be experiencing a complex array of symptoms and potentially be exposed to complex treatment regimens. We are hence excluding this group to limit the effects of these potential confounding factors on the intervention outcomes.

b. Participants taking psychotropic medication, who are not on a stable dose for the 8 weeks prior to starting the study. Rationale: Since change in psychotropic medication can be associated with sporadic changes in mood and behaviour, we are excluding this group to reduce risk of having our treatment effects confounded by the effect of such medications.

c. Children with co-morbid somatisation, eating disorders, significant intellectual disability (suspected or confirmed IQ <70), bipolar disorder, recent psychiatric hospitalization, or severe suicidal ideation or treatment-interfering substance abuse. Rationale: We are excluding this group because these conditions sometimes increased risk of/overlap with anxiety and depression symptoms and pose a high risk of confounding our measurements on these outcomes.

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 concealment will be maintained by ensuring that project staff who determine participant illegibility for inclusion in the study will not be aware of the participants' group allocation. This will be done by randomly allocating group membership to participants using sequentially numbered sealed envelopes, and this random allocation process will be managed by an independent researcher who will not be involved in recruitment or intervention delivery. This method will be used to randomly assign participants to the UP-C/A intervention (n = 30) and the waitlist control (n = 30) groups, who will receive the intervention immediately and 8 weeks after enrolling in the study, respectively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation (using sequentially numbered sealed envelopes).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
All assessors will be blind to group assignment for all assessment time points beyond baseline. Participants will not be blinded to group allocation in this study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Justification:

This study aims to include 30 participants each in the immediate intervention and waitlist control groups. G*Power was used for sample size calculation for a within-between factors repeated measures analysis of variance (ANOVA). The model estimates that with two independent groups (intervention and waitlist controls) and three assessment timepoints (baseline, immediate post-intervention, 3months-post), a total sample size of 34 (i.e., about 17 participants per group) is required to attain a small effect size (Cohen’s f = 0.23) at an alpha of 0.05 and 0.80 power. This indicates that the study is sufficiently powered to detect a similar/higher effect size with the expected sample size of 30 in each group. The UP intervention has been associated with a greater effect size (minimum d = 1.90) in adolescents with anxiety and depression in a waitlist-controlled trial. However, our selected smallest effect of interest is based on a meta-analysis (in both children and adults) that reported that UP treatment for both anxiety and depression was associated with an effect size of g = 0.45, which is equivalent to f = 0.23..


Data Analysis:

Data will be cleaned and analysed in SPSS or R. For each analysis, data will be checked to ensure adherence to all statistical assumptions (e.g., normality, linearity, homoscedasticity). Little’s Missing Completely at Random Test (MCAR) will be used to determine pattern of missing data, and missing values will be managed based on methods compatible with respective statistical models (e.g., multiple imputation, mean substitution). Between-group comparisons on baseline characteristics will be carried out using t-tests, chi-squared tests, and Mann-Whitney U tests (as applicable).

To evaluate efficacy of the UP-A/C intervention, mean differences in depression and anxiety scores on the RCADS will be compared between the two groups at three timepoints (baseline, immediate post-intervention, and 3 months post-intervention) using linear mixed models.

Treatment feasibility will be assessed by comparing group scores on the Credibility and Expectancy Questionnaire as well as a study-designed feasibility tool using chi-squared tests.

Linear mixed models will be used to evaluate the relationships between the UP-A/C intervention and each functional outcome (i.e., self-esteem, adaptive behavior, health-related quality of life, and sleep) across these three analysis timepoints (baseline, immediate post-intervention, and 3 months post-intervention), including relevant covariates.

For all analyses, means, standard deviations, p-values, confidence intervals, and effect sizes will be reported, where available.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2025
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23579 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 39000 0
3052 - Parkville
Recruitment postcode(s) [2] 39001 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 312674 0
Hospital
Name [1] 312674 0
Royal Children's Hospital Foundation, through MCRI Mental Health Strategy
Country [1] 312674 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
Murdoch Children's Research Institute, The Royal Children's Hospital, 50 Flemington Road Parkville, Victoria 3052 Australia.
Country
Australia
Secondary sponsor category [1] 317761 0
Individual
Name [1] 317761 0
Dr Louise Crowe
Address [1] 317761 0
Clinical Psychology Department, Royal Children's Hospital, 50 Flemington Road Parkville, Victoria 3052 Australia.
Country [1] 317761 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311977 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 311977 0
Ethics committee country [1] 311977 0
Australia
Date submitted for ethics approval [1] 311977 0
28/04/2023
Approval date [1] 311977 0
Ethics approval number [1] 311977 0
RCH HREC: 90983

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

Contacts
Principal investigator
Name 123034 0
Dr Louise Crowe
Address 123034 0
Murdoch Children's Research Institute, 50 Flemington Road, PARKVILLE, VIC, 3052 Australia
Country 123034 0
Australia
Phone 123034 0
+61 03 9936 6762
Fax 123034 0
Email 123034 0
louise.crowe@mcri.edu.au
Contact person for public queries
Name 123035 0
Louise Crowe
Address 123035 0
Murdoch Children's Research Institute. 50 Flemington Road, PARKVILLE, VIC, 3052 Australia
Country 123035 0
Australia
Phone 123035 0
+61 03 9936 6762
Fax 123035 0
Email 123035 0
louise.crowe@mcri.edu.au
Contact person for scientific queries
Name 123036 0
Louise Crowe
Address 123036 0
Murdoch Children's Research Institute 50. Flemington Road, PARKVILLE, VIC, 3052 Australia
Country 123036 0
Australia
Phone 123036 0
+61 03 99366762
Fax 123036 0
Email 123036 0
louise.crowe@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share participant data from this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18528Statistical analysis plan  louise.crowe@mcri.edu.au Contact Principal Investigator - Dr Louise Crowe 384994-(Uploaded-19-12-2023-14-47-48)-Study-related document.doc



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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