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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]

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)

Mental health (anxiety)

Mental health (depression)

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Mental Health

Other mental health disorders

Metabolic and Endocrine

Diabetes

Neurological

Epilepsy

Neurological

Multiple sclerosis

Inflammatory and Immune System

Autoimmune diseases

Inflammatory and Immune System

Rheumatoid arthritis

Respiratory

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]

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]

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]

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]

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]

Secondary outcome [1]

Outcome: Self-Worth
Measure: The Harter Self Perception Measure (HSPM)

Timepoint [1]

T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion

Secondary outcome [2]

Outcome: Adaptive behaviour
Measure: Adaptive Behaviour Assessment Systems

Timepoint [2]

T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion

Secondary outcome [3]

Outcome: Health-related quality of life
Measure: Child Health Utility- 9D ( CHU-9D)

Timepoint [3]

T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion

Secondary outcome [4]

Outcome: Sleep
Measure: Sleep Disturbance Scale for Children

Timepoint [4]

T1 - Baseline
T3 - End of the intervention (maximum 6 months post-intervention commencement)
T4 - 3 months post-intervention completion

Secondary outcome [5]

Outcome: Intervention feasibility Measures:
- Feasibility, Acceptability, Appropriateness Questionnaire

Timepoint [5]

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]

Outcome: Intervention feasibility Measures:
- Study-designed feasibility questionnaire

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3052 - Melbourne University

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Children's Hospital Foundation, through MCRI Mental Health Strategy

Address [1]

The Royal Children's Hospital, 50 Flemington RoadParkville, Victoria 3052 Australia

Country [1]

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]

Individual

Name [1]

Dr Louise Crowe

Address [1]

Clinical Psychology Department, Royal Children's Hospital, 50 Flemington Road Parkville, Victoria 3052 Australia.

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The Royal Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

50 Flemington Road Parkville, 3052 Melbourne, Victoria Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/04/2023

Approval date [1]

Ethics approval number [1]

RCH HREC: 90983

Summary

Brief summary

Children and adolescents with ongoing medical conditions (example, epilepsy, asthma) often experience mental health problems due to their illness and other factors. A lot of the time when children are having mental health problems, they have symptoms of both anxiety and depression. Our project aims to test if a transdiagnostic therapy can help tackle this issue. Transdiagnostic means that the therapy can help treat the mental health problem that the child has (example, anxiety) and any other related mental health problems, like depression. 

Through this project, we want to learn whether this new therapy can help in reducing anxiety and depression symptoms in children and adolescents with these ongoing medical conditions. We are hoping to recruit 60 children and adolescents (8-17.11 years) with chronic medical conditions, who also present with anxiety or depressive symptoms. These children will be recruited from the Royal Children’s Hospital Clinical Psychology Service. 

By understanding its effectiveness, we aim to offer this therapy to more families who could benefit from it.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Louise Crowe

Address

Murdoch Children's Research Institute, 50 Flemington Road, PARKVILLE, VIC, 3052 Australia

Country

Australia

Phone

+61 03 9936 6762

Fax

[email protected]

Contact person for public queries

Name

Louise Crowe

Address

Murdoch Children's Research Institute. 50 Flemington Road, PARKVILLE, VIC, 3052 Australia

Country

Australia

Phone

+61 03 9936 6762

Fax

[email protected]

Contact person for scientific queries

Name

Louise Crowe

Address

Murdoch Children's Research Institute 50. Flemington Road, PARKVILLE, VIC, 3052 Australia

Country

Australia

Phone

+61 03 99366762

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
18528	Statistical analysis plan			[email protected]	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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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