None listed
Conditions
Brief summary
This randomised controlled trial (RCT) seeks to assess the efficacy of psychological group intervention for children with type-1 diabetes and anxiety, including their primary caregiver. The intervention is an adaption of an existing manualised cognitive behavioural therapy program combined with self-compassion content and exercises. Qualified clinicians (including a clinical psychologist and either a paediatric diabetes nurse educator or a paediatric social worker) will run these group interventions (with 5-8 families at a time) at the Children’s Hospital at Westmead, Sydney. Primary Aims: Reduction in anxiety symptoms in the child (as reported by child, primary and parent/ care giver). Secondary Aims: Improvement in metabolic outcomes (HbA1c) and other psychosocial outcomes (self-compassion, diabetes self-care behaviours, parental wellbeing) We hypothesise that both parents and children will report significant improvement in the following primary outcomes compared to the waitlist control group: 1. Decreased anxiety symptoms in the child (as reported by child, and parent/caregiver) 2. Decreased anxiety symptoms in the parent/caregiver (as reported by parent/caregiver) We anticipate these changes will occur from baseline to post assessment, and be maintained at the follow-up time point (at least 3 months later). 3.2 Secondary Objectives We also hypothesise that results will show significant improvement in the following secondary outcomes compared to the waitlist control group: 1. Improved metabolic outcomes (HbA1c reading) 2. Increased self-compassion in the child (as reported by child) 3. Increased health-related diabetes self-care behaviours in the child (as reported by child) 4. Improved parental outcomes (parent’s own anxiety symptoms and self-compassion) 5. Improved child behaviour as measured by the strengths and difficulties questionnaire completed by the parent The secondary outcome of this study is to assess the practicality and feasibility of the SCAN intervention. This will be assessed by attendance records and open-ended qualitative questions about what the participants found helpful (or not helpful) about the intervention.
Interventions
This novel group intervention consists of a 5-week, 90-minute cognitive-behavioral therapy (CBT) and self-compassion group intervention. This intervention will utilize scenarios and skills related to the experience of being diagnosed with diabetes, and address the need to reduce symptoms of anxiety. This novel, manualized intervention is grounded in CBT and self-compassion/ compassion-focused therapy (CFT) principles. Sessions will provide psychoeducation around the nature of anxiety, and the be
This novel group intervention consists of a 5-week, 90-minute cognitive-behavioral therapy (CBT) and self-compassion group intervention. This intervention will utilize scenarios and skills related to the experience of being diagnosed with diabetes, and address the need to reduce symptoms of anxiety. This novel, manualized intervention is grounded in CBT and self-compassion/ compassion-focused therapy (CFT) principles. Sessions will provide psychoeducation around the nature of anxiety, and the benefits of CBT and self-compassion, as well as introducing skills such as thought challenging, problem-solving, graded exposure, assertive communication skills, and the development of self-compassion. Self-report measures will be collected pre and post intervention, in addition to a 3-month follow-up. Within each session, there will be a portion in which both the young people and their caregivers are both present, a section in which the young people are independent of their caregivers, and a section where caregivers are independent of the participants. These group sessions will be run by several professionals including a registered psychologist with clinical endorsement, diabetes nurse educator and diabetes social worker. Groups will be conducted at Westmead Children's hospital in a group treatment room. Participant attendance will be recorded to monitor adherence to the intervention.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants for the study will be aged between 10-14 years of age, and their primary carer. Participants will be diagnosed with diabetes by a pediatric endocrinologist, and have subclinical or clinical symptoms of anxiety. Subclinical anxiety occurs when an individual has symptoms of anxiety that impact their functioning but does not meet criteria for any anxiety disorders in the DSM 5, whilst clinical anxiety is when a participant does reach criteria of a DSM 5 anxiety disorder. Participants must have a primary caregiver who is able to commit to attending the program, and both participant and caregiver must have adequate English efficiency to engage in the program.
Exclusion criteria
• The child has a learning or developmental delay diagnosis that would prevent them from understanding the requirements of the study or/and engaging in the program • The child is concurrently participating in other psychosocial intervention programs for diabetes
Outcome results
None listed