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Trial registered on ANZCTR


Registration number
ACTRN12623000396628
Ethics application status
Approved
Date submitted
29/03/2023
Date registered
19/04/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of guided parent-delivered Cognitive Behaviour Therapy for children's perfectionism
Scientific title
A randomised controlled feasibility trial of guided parent-delivered Cognitive Behaviour Therapy for children's perfectionism
Secondary ID [1] 308709 0
Nil
Universal Trial Number (UTN)
U1111-1286-8492
Trial acronym
STRATOSPHERIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perfectionism 328642 0
depression 329685 0
eating disorders 329686 0
Condition category
Condition code
Mental Health 325653 325653 0 0
Depression
Mental Health 325654 325654 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Guided parent-delivered cognitive behaviour therapy for perfectionism (GPD-CBT-P) comprises of 6 sessions. Session 1 focuses on psychoeducation about the definition of perfectionism, exploring the difference between high standards and perfectionism, myths of the advantages of perfectionism and exploring reasons to change. The second session focuses on what keeps perfectionism going, examining typical unhelpful thinking patterns and behaviours that maintain perfectionism and how parental expectations and criticism can contribute to this. The third session focuses on setting up behavioural experiments with the children, to test out the truth or otherwise of their perfectionistic predictions and development of alternative beliefs. The fourth session focuses on psychoeducation about self-criticism, identifying the critical voice, identifying the compassionate voice, and involves parents asking their child to generate as many self-compassionate interpretations as possible for another child in a challenging hypothetical situation. The fifth session focuses on behaviours that can reinforce perfectionism, such as procrastination and checking, using problem solving. The sixth session focuses on the relationship between self-worth and achievement; identifying various factors that impact self-worth and to develop a program to expand those areas that are not linked to achievement. The content of the modules is drawn from the book "Overcoming perfectionism: A self-help guide using cognitive behavioural techniques". The content will be co-designed with parents in the first three months of the research to ensure that the content is suitably modified for use by parents with their children and has age-appropriate material. This co-design process will consist of a one-hour online focus group meeting, with up to 10 parents, where outcome will be decided by majority opinion. Over 6 sessions, delivered per parent dyad, both parents (where possible) will be guided through the content of the modules and encouraged to apply the content to themselves, as well as to instruct their children in the content they are learning. The guidance will be offered by trainee psychologists under expert supervision.
The approach is standardised yet can be flexibly delivered according to a families’ concerns, problems, and goals. Consistent with previous cost-effective online brief guided parent-delivered CBT for child anxiety, parents will be given a pdf of the intervention followed by six weekly online (remote) sessions with the trial guides, of up to 6 hours total contact. Each session will involve collaboratively setting an agenda for the session based on experience with the preceding week’s homework, current issues, and the module in focus. Participants will complete homework exercises to consolidate and practice the skills learnt during the session. To enable homework completion, worksheets will be prepared for the child with explanatory notes for the parents. Examples of homework include: completing a worksheet titled ‘Adam and Lucy’, which the child can complete with the parent to practise identifying perfectionism and how it is different to striving for high standards or excellence; completing the worksheet titled ‘Being Your Own Friend’, which the child can complete with the parent to practise using compassion for a fictional character, and then for themselves.
Intervention code [1] 325766 0
Prevention
Comparator / control treatment
Wait list control group. Participants in the waitlist control will be informed of their status and will receive the pdf material at the end of 18 weeks.
Control group
Active

Outcomes
Primary outcome [1] 334311 0
For children we will use two subscales of the Almost Perfect Scale-Revised: High Standards (7 items) and Discrepancy (11 items). Items are rated on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). High Standards is intended to assess adaptive and healthy striving while Discrepancy assesses the perception that personal high standards are not being met.
Timepoint [1] 334311 0
18-weeks post-randomisation.
Primary outcome [2] 334439 0
For parents we will use the 12-item Clinical Perfectionism Questionnaire, a self-report measure of clinical perfectionism developed to assess the impact of CBT-P. It has acceptable internal consistency and validity.
Timepoint [2] 334439 0
18-weeks post-randomisation
Primary outcome [3] 334440 0
Interest in study assessed by number of enquiries using audit of study enrolment data
Timepoint [3] 334440 0
Assessed after enrolment of first 22 participants
Secondary outcome [1] 420211 0
Perceived Stress Scale: Children. This 10-item measure is widely used for the early identification of children at risk of anxiety/stress. It is measured on a 4-point scale (Never to a Lot), with example items including: “How often do you feel worried about being too busy?”, “How often do you feel worried about your grades or school?”
Timepoint [1] 420211 0
18-weeks post-randomisation
Secondary outcome [2] 420212 0
Centre for Epidemiological Studies Depression Scale for Children. This 20-item self-report depression inventory is commonly used to measure depression in children. Each response to an item is scored as follows: 0 = “Not at All” 1 = “A Little” 2 = “Some” 3 = “A Lot”. Principal components analysis with children and adolescents identified three distinct factors: behavioral and cognitive components of depression and a happiness dimension.
Timepoint [2] 420212 0
18-weeks post-randomisation
Secondary outcome [3] 420213 0
Body image and associated behaviours (e.g., My child compares their body negatively to others, My child feels nervous or uptight about their weight, My child follows strict rules about their eating, My child feels uptight or nervous about their body shape) using the Eating Disorder 15 items (ED15).
Timepoint [3] 420213 0
18-weeks post-randomisation
Secondary outcome [4] 420214 0
Satisfaction with school comprises six indicators, introduced by a question regarding the level of satisfaction: “How satisfied are you with each of the following things in your life?: Other children in your class?; Your school marks?; Your school experience?; Your life as a student?; Things you have learned?; and Your relationship with teachers?”. The response options were coded from 0 “Not at all satisfied” to 10 “Totally satisfied”.
Timepoint [4] 420214 0
18-weeks post-randomisation
Secondary outcome [5] 420215 0
8-item academic self-efficacy subscale (“How well do you succeed in finishing all your homework every day?”) from the Self-efficacy Questionnaire for Children
Timepoint [5] 420215 0
18-weeks post-randomisation
Secondary outcome [6] 420625 0
number recruited into the trial (primary outcome) using audit of study enrolment
Timepoint [6] 420625 0
Assessed after enrolment of first 22 participants
Secondary outcome [7] 420626 0
number completing first assessment (primary outcome) using audit of study enrolment
Timepoint [7] 420626 0
Assessed after enrolment of first 22 participants
Secondary outcome [8] 420627 0
number randomised using audit of study enrolment
Timepoint [8] 420627 0
Assessed after enrolment of first 22 participants
Secondary outcome [9] 420628 0
number retained in treatment (primary outcome) using audit of study enrolment
Timepoint [9] 420628 0
18-weeks post-randomisation
Secondary outcome [10] 420629 0
number of completed assessments at each timepoint (primary outcome) using audit of study enrolment
Timepoint [10] 420629 0
18-weeks post-randomisation
Secondary outcome [11] 420630 0
percentage of homework tasks completed between sessions (primary outcome) using self-report
Timepoint [11] 420630 0
18-weeks post-randomisation
Secondary outcome [12] 420631 0
total hours of guidance used by each family (primary outcome) using therapist report
Timepoint [12] 420631 0
18-weeks post-randomisation
Secondary outcome [13] 420632 0
treatment credibility, acceptability and effectiveness - self report using the Credibility Expectancy Questionnaire
Timepoint [13] 420632 0
6-weeks post-randomisation
Secondary outcome [14] 420636 0
Happiness - Happiness is assessed by asking: “Overall, how happy have you been feeling during the last two weeks?”, with response options from 0 “Not at all happy” to 10 “Totally happy”.
Timepoint [14] 420636 0
18-week post-randomisation

Eligibility
Key inclusion criteria
The child is aged 7 to 12 years and the parents identify that their child has elevated perfectionism that causes problems to their psychosocial functioning. Questions will include: “Does your child set extremely high standards for themself? Do they chase these standards even if it leads to bad effects e.g., stress, low moods, anxiety, self-criticism, procrastination? Do they often feel disappointed after completing a task because they feel they could have done better?”. Our previous work has shown self-identification of perfectionism results in 72% of participants scoring at least one standard deviation above published norms on the Frost Concern over Mistakes subscale.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Receiving other psychological services for perfectionism while participating in the trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be achieved using computer-generated (http://www.jerrydallal.com/random/randomize.htm), quasi-random numbers and will be conducted by an independent researcher not associated with the research. Once generated, this information is passed to the project coordinator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation - eligible families will be stratified according to scores on the Discrepancy scale of the Almost Perfect Scale – Revised. Male children scoring greater than or equal to 46.9 and female children scoring greater than or equal to 48.6 will be assigned as having high discrepancy and children under these cut off scores will be assigned as having low discrepancy.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
13/11/2023
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
66
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
SA,WA

Funding & Sponsors
Funding source category [1] 312933 0
Charities/Societies/Foundations
Name [1] 312933 0
Channel 7 Children’s Research Foundation
Country [1] 312933 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 315312 0
Individual
Name [1] 315312 0
Tracey Wade
Address [1] 315312 0
Flinders University
GPO Box 2100, Adelaide, SA, 5001
Country [1] 315312 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312205 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 312205 0
Flinders University,
GPO Box 2100, Adelaide, SA, 5001
Ethics committee country [1] 312205 0
Australia
Date submitted for ethics approval [1] 312205 0
16/11/2022
Approval date [1] 312205 0
22/12/2022
Ethics approval number [1] 312205 0
5816

Summary
Brief summary
We aim to examine the feasibility of a new guided parent-delivered CBT-P (GPD-CBT-P) whose child is aged between 7 and 12 years of age in terms of recruitment through educational settings and retention rates. In addition, we will gather data how GPD-CBT-P performs against waitlist control for change over 18-weeks post-randomisation on self-report (parent and child) measures of perfectionism, stress, depressive symptoms, and body image disturbance. In addition, this will be the first occasion that academic outcomes (satisfaction and self-efficacy) will be examined in a randomised controlled trial design. This is a feasibility trial that will provide a plausible range of point estimates of the efficacy of GPD-CBT-P on standardised continuous symptom measures for our secondary aim. In this way, we can refine the treatment manual and contribute to the design. As a feasibility study we do not pose hypotheses but will examine our primary outcomes (number of enquiries, number recruited into the trial, number completing first assessment, number randomised, number retained in treatment, number of completed assessments at each timepoint, percentage of homework tasks completed between sessions, total hours of guidance used by each family), as well as the perceived treatment credibility, acceptability and effectiveness, and the between group effect sizes (95% confidence intervals) for our measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123842 0
Prof Tracey Wade
Address 123842 0
Flinders University,
GPO Box 2100, Adelaide, SA 5001
Country 123842 0
Australia
Phone 123842 0
+61 882013736
Fax 123842 0
+61882013877
Email 123842 0
[email protected]
Contact person for public queries
Name 123843 0
Tracey Wade
Address 123843 0
Flinders University,
GPO Box 2100, Adelaide, SA 5001
Country 123843 0
Australia
Phone 123843 0
+61 882013736
Fax 123843 0
+61882013877
Email 123843 0
[email protected]
Contact person for scientific queries
Name 123844 0
Tracey Wade
Address 123844 0
Flinders University,
GPO Box 2100, Adelaide, SA 5001
Country 123844 0
Australia
Phone 123844 0
+61 882013736
Fax 123844 0
+61882013877
Email 123844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
January 2025, no end date determined
Available to whom?
Other researchers
Available for what types of analyses?
Meta-analyses and replication analyses
How or where can data be obtained?
Tracey Wade's Open Science Framework site: https://osf.io/rtzv3/


What supporting documents are/will be available?

No Supporting Document Provided



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.