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Trial registered on ANZCTR


Registration number
ACTRN12619000619145
Ethics application status
Approved
Date submitted
3/04/2019
Date registered
26/04/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SCAN Study - Self Compassion & Cognitive Behavioural Therapy (CBT): Early family intervention for children with Type 1 diabetes experiencing anxiety
Scientific title
SCAN Study - Self Compassion & CBT: Early family intervention an anxiety levels and diabetes outcomes in children with Type 1 diabetes experiencing anxiety
Secondary ID [1] 296077 0
None
Universal Trial Number (UTN)
Trial acronym
SCAN Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 310799 0
Anxiety 311167 0
Condition category
Condition code
Metabolic and Endocrine 309470 309470 0 0
Diabetes
Mental Health 309471 309471 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313353 0
Treatment: Other
Intervention code [2] 314252 0
Behaviour
Comparator / control treatment
A waitlist control will be utilized, This group will continue to receive routine hospital care for diabetes management. The waitlist control group will then be offered the opportunity to complete the program, after three sets of control data have been collected. The waitlist control will be offered intervention after the 3 month follow-up data is collected.
Control group
Active

Outcomes
Primary outcome [1] 318684 0
Child anxiety symptoms as reported by the parent/caregiver using the parent/caregiver version of the Youth Anxiety Measure for DSM 5 (YAM-5) (Muris et al. 2017)
Timepoint [1] 318684 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Primary outcome [2] 318836 0
Parent/caregiver anxiety symptoms, as measured by parent/caregiver self-report using the Depression Anxiety and Stress Scale (DASS21) (Lovibond & Lovibond, 1995)
Timepoint [2] 318836 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Primary outcome [3] 319816 0
Child anxiety symptoms as reported by the child using the child version of the Youth Anxiety Measure for DSM 5 (YAM-5) (Muris et al. 2017)
Timepoint [3] 319816 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Secondary outcome [1] 365687 0
Self-compassion scores of the child, measured through Self-Compassion Scale (short form) (Raes, Pommier, Neff, & Van Gucht, 2011),
Timepoint [1] 365687 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Secondary outcome [2] 366211 0
Metabolic outcomes measured through HbA1c assessed by serum assay,
Timepoint [2] 366211 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Secondary outcome [3] 366212 0
Practicality and feasibility of the SCAN intervention will be measured via attendance records. In addition, open-ended qualitative questions will be included in the surveys. These questions will ask what the participants found helpful (or not helpful) about the intervention, and whether they would recommend the program to a friend. This will be assessed using a questionnaire specifically designed for this study.
Timepoint [3] 366212 0
At completion of intervention, after 5 weeks
Secondary outcome [4] 366213 0
Barriers to diabetes adherence in child participants using the Barriers to diabetes adherence measure (21- items) (Mulvaney et al., 2011) measure (21- items) (Mulvaney et al., 2011)
Timepoint [4] 366213 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Secondary outcome [5] 366214 0
Difficulties of living with diabetes will be assessed using the Strengths and Difficulties Questionnaire (27 items) (Goodman, 1997). This will be completed by parent participants, about their child.
Timepoint [5] 366214 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.
Secondary outcome [6] 369596 0
Self-compassion scores of the parent/caregiver, measured through Self-Compassion Scale (short form) (Raes, Pommier, Neff, & Van Gucht, 2011),
Timepoint [6] 369596 0
Pre intervention, at completion of intervention after 5 weeks, and 3 month follow up.

Eligibility
Key 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.
Minimum age
10 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
Central randomisation, computer-generated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated in blocks to either a treatment or control condition. Expected sample size will be 80 participants, equally distributed across both intervention and waitlist control.
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
Participant characteristics, treatment details and study outcomes will be described within and between groups using standard statistical methods: frequencies and percentages for categorical variables and mean (SD) or median (interquartile range) and range for continuous variables.
All analyses will be performed according each participant’s randomised treatment, regardless of treatment received. The primary outcome of the difference in mean YAM - 5 score between the two interventions will be analysed using a two-sample t-test. Other outcomes will also be compared between groups using standard tests including chi-square tests for categorical outcomes and t-tests for continuous outcomes. Regression models will be used to explore predictors of outcome and perform adjusted analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12718 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 25144 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 300668 0
Hospital
Name [1] 300668 0
The Children's Hospital at Westmead
Address [1] 300668 0
Department of Endocrinology, Cnr Hawkesbury Rd &, Hainsworth St, Westmead NSW 2145
Country [1] 300668 0
Australia
Funding source category [2] 302547 0
University
Name [2] 302547 0
Australian Catholic University
Address [2] 302547 0
School of Psychology,
Australian Catholic University
25a Baker Road,
Strathfield, NSW 2135
Country [2] 302547 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
School of Psychology
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 301417 0
University
Name [1] 301417 0
Australian Catholic University
Address [1] 301417 0
Australian Catholic University
25a Baker Road,
Strathfield, NSW 2135
Country [1] 301417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301450 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 301450 0
Corner Hawkesbury Road and Hainsworth Street Locked Bag 4001 Westmead NSW 2145 Sydney Australia DX 8213 Parramatta
Ethics committee country [1] 301450 0
Australia
Date submitted for ethics approval [1] 301450 0
25/10/2017
Approval date [1] 301450 0
04/05/2018
Ethics approval number [1] 301450 0
HREC/17/SCHN/420

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87046 0
Dr Madeleine Ferrari
Address 87046 0
Australian Catholic University

640.G.02, Ground floor, Edward Clancy Building 25A Barker Road, Strathfield, NSW 2135
Country 87046 0
Australia
Phone 87046 0
+612 9701 4726
Fax 87046 0
Email 87046 0
madeleine.ferrari@acu.edu.au
Contact person for public queries
Name 87047 0
Dr Madeleine Ferrari
Address 87047 0
Australian Catholic University

640.G.02, Ground floor, Edward Clancy Building 25A Barker Road, Strathfield, NSW 2135
Country 87047 0
Australia
Phone 87047 0
+612 9701 4726
Fax 87047 0
Email 87047 0
madeleine.ferrari@acu.edu.au
Contact person for scientific queries
Name 87048 0
Dr Madeleine Ferrari
Address 87048 0
Australian Catholic University

640.G.02, Ground floor, Edward Clancy Building 25A Barker Road, Strathfield, NSW 2135
Country 87048 0
Australia
Phone 87048 0
+612 9701 4726
Fax 87048 0
Email 87048 0
madeleine.ferrari@acu.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
To protect the confidentially of participants, data will only be reported in aggregated form in subsequent conference presentations and publications
What supporting documents are/will be available?
Informed consent form
Summary results
No Results