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Helping young people with chronic medical conditions experiencing anxiety and depression

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000114549
Acronym
UP-CAM (Unified Protocol for Children and Adolescents with Medical illness/condition)
Enrollment
60
Registered
2024-02-08
Start date
2024-09-02
Completion date
2025-12-30
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 comm

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.

Sponsors

Murdoch Children's Research Institute
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026