Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000974202
Ethics application status
Approved
Date submitted
25/04/2018
Date registered
8/06/2018
Date last updated
8/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive behavioural intervention for social perspective taking in children with epilepsy: a feasibility trial
Scientific title
Cognitive behavioural intervention to improve Theory of Mind (ToM) and social competence in children with epilepsy: a case series feasibility trial
Secondary ID [1] 294718 0
Nil known.
Universal Trial Number (UTN)
U1111-1212-9196
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 307601 0
Condition category
Condition code
Neurological 306657 306657 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Cognitive behavioural intervention for social perspective taking in children with epilepsy.

Materials. The intervention will be taught via a range of mediums including written social stories, cartoons, video vignettes, role-plays and paper and pen tasks, which are all outlined in the intervention workbooks. Separate workbooks have been created for children, parents and the investigators. Child workbooks contain activities designed to teach social perspective taking skills. Investigator workbooks mirror the content of the child workbook, with additional scripts included for instruction and feedback. Parent workbooks contain a brief overview of skills taught to children and additional activities for the parent-child review sessions. Assessments with children will involve standardised behavioural tasks and questionnaires that assess ToM, social competence and overall treatment acceptability. Parents will complete standardised questionnaires assessing ToM, social competence, cognitive skills, overall treatment acceptability and barriers and facilitators to attendance. Independent clinicians will complete standardised questionnaires assessing barriers and facilitators to attendance and an attitudes and practice scale. All intervention materials can be accessed by contacting the lead author of the study.

Procedures. Children will participate in 4 small group workshops and complete 4 one-to-one assessments with an investigator. Additional support will be provided to parents via weekly phone calls. These will be used to monitor progress and assist parents with helping their child implement skills. Upon completion of the study, parents and children will attend individual face-to-face debriefing sessions and complete online questionnaires assessing treatment acceptability and barriers and facilitators to attending the program.

Providers. Intervention sessions will be led by psychologists who hold general registration with the Psychology Board of Australia and have experience working with children with and without epilepsy. Diagnoses of epilepsy will be confirmed by treating neurologists.

Modes of delivery. The intervention will involve face-to-face groups, which children will participate in with 1 to 5 other children who are a similar age and have a diagnosis of epilepsy. Assessments will take place in a one-to-one face-to-face format with an investigator. Parents will complete questionnaires online.

Frequency and duration. The intervention will involve 4 small group workshops, held weekly over 4 consecutive weeks. Each workshop will contain 2 to 3 x 50-minute sessions, separated by 10 to 20 minute breaks. Children will attend these workshops without their parents. Parents will attend a 30-minute review session with their child at the end of each day.
Assessments will take place at 4 time-points: baseline (4 to 6 weeks before treatment), pre-treatment (first day of intervention or up to 7 days prior), post-treatment (last day of intervention of up to 7 days after treatment has been completed), and follow-up (4 to 6 weeks after treatment). Child assessments will take 15 to 35 minutes. Questionnaires completed by parents will take 55 to 75 minutes. Two brief weekly measures will be taken from parents and children over the telephone, taking 1 to 5 minutes each.

Location. The intervention sessions will be held at the Psychology Clinic at the University of Sydney. Assessments will take place at the Psychology Clinic or at participants’ homes. Weekly support and measures will be obtained over the telephone.

Tailoring. The intervention follows a standardised program, as outlined in the child, parent and investigator workbooks. However, investigators will provide individualised support and feedback to families during the weekly phone calls.

Adherence. Adherence is being assessed as one of the primary feasibility aims. Home-based catch up sessions will be provided in unavoidable circumstances where children miss a treatment session. These are being provided to decrease barriers to attendance and assist with completion of the program.
Intervention code [1] 301012 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305658 0
Recruitment: will be deemed feasible if it is possible to recruit 2 to 6 children with epilepsy, from a total of 6 to 10 invited to participate (i.e. 1/3 of those invited are recruited).
Timepoint [1] 305658 0
After enrolment is complete, and before the first intervention session.
Primary outcome [2] 305659 0
Retention. A retention rate (i.e., children who commence and complete the study) of 60-80% will be considered acceptable (i.e. if 6 children commence the study, then 4 to 5 should complete all 4 training days OR if only 2 children commence the study, both should complete all 4 training days).
Timepoint [2] 305659 0
Retention will be assessed on the final day of the intervention.
Primary outcome [3] 305660 0
Overall acceptability of the intervention will be evaluated with the Treatment Evaluation Inventory (TEI, Kazdin, 1980), which will be completed by to parents, children and clinicians. A composite score will be used by summing the total score for each informant on this measure.
Timepoint [3] 305660 0
The TEI will be completed at the follow-up assessment.
Secondary outcome [1] 346058 0
Change in childrens' Theory of Mind performance will be evaluated with the Strange Stories task, which is a standardized behavioural measure of ToM.
Timepoint [1] 346058 0
The strange stories task will be completed by children at 4 time-points: baseline (2 to 6 weeks before the intervention begins), pre-treatment (first day of intervention or up to 7 days prior), post-treatment (last day of intervention of up to 7 days after), and follow-up (2 to 6 weeks after the intervention).
Secondary outcome [2] 346059 0
Change in social competence will be assessed with a composite score, including questions completed by children and parents: (i) Social Competence subscale of the Self-Perception Profile for Children (SPP-C), and single-item measure of social competence will be completed by children and summed to give a total social competence score for each week; (ii) Strength and Difficulties Questionnaire (SDQ), Social Responsiveness Scale (SRS), Child Behaviour Checklist (CBCL), Social Competence subscale of the Self-Perception Profile for Children (SPP-C parent), and single-item measure of social competence will be completed by parents.
Timepoint [2] 346059 0
Children will complete social competence measures (SSP-C and single item) weekly throughout the study (from baseline to follow-up). Parents will complete the same measures as children (SSP-C and single item) weekly throughout the program. Parents will complete the other standardised measures (SDQ, SRS, CBCL) at the 4 assessment time-points: baseline (4 to 6 weeks before treatment), pre-treatment (first day of intervention or up to 7 days prior), post-treatment (last day of intervention of up to 7 days after treatment has been completed), and follow-up (4 to 6 weeks after treatment).
Secondary outcome [3] 347877 0
Barriers and facilitators to implementation for children and families will be evaluated with the Barriers to Treatment Participation Scale (BTPS, Kazdin, Holland, Crowley, & Breton, 1997), which will be completed by parents and clinicians.
Timepoint [3] 347877 0
The BTPS will be completed after the final, follow-up assessment.
Secondary outcome [4] 347878 0
Barriers and facilitators to implementation in clinical practice. The Evidence-Based Practice Attitude Scale (EBPAS, Rye, Torres, Friborg, Skre, & Aarons, 2017) will be completed by a small group of independent clinicians who are not involved in the project but work therapeutically with children and adolescents. This will provide an indication of their impressions of its utility as a clinical tool and likelihood of implementing it in their clinical practice.
Timepoint [4] 347878 0
This will be completed separately to the intervention itself, at a time suitable to the clinician, and before the follow-up assessments are complete.
Secondary outcome [5] 347879 0
Process time for intervention modules. Each modules will be considered successful if can content can be covered in 30 to 60 minutes (acceptable range < 60 minutes). Sessions that run >60 minutes will be evaluated and modified.
Timepoint [5] 347879 0
This will be evaluated throughout the intervention, with the processing time recorded for each module, in each workshops.

Eligibility
Key inclusion criteria
(i) A current diagnosis of genetic generalised epilepsy (GGE) or temporal lobe epilepsy (TLE) confirmed by treating neurologists
(ii) Aged between 8 to 16 years old
(iii) Fluency in the English language
(iv) Assessed to have a full scale intellectual quotient (FSIQ) > 70
(v) Absence of major developmental/psychiatric conditions (i.e. autism), sensory/motor impairments (i.e. cerebral palsy, significant visual or hearing impairments), major neurological disorder (e.g. severe brain injury), systemic and metabolic disorders that could lead to cognitive impairment
(vi) No clinical signs of drug intoxication/drug and alcohol abuse
(viii) Absence of a neurological procedure/surgery in the past 3 months.
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) No longer meet criteria for GGE or TLE, as their epilepsy has been classified as ‘resolved’ by their treating neurologists. Epilepsy is considered resolved for individuals who had an age-dependent epilepsy syndrome but are now past the applicable age or those who have remained seizure-free for the last 10 years, with no seizure medicines for the last 5 years (Fisher et al. 2014)
(ii) Have had a neurological procedure/surgery in the past 3 months.

Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, et al. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014;55(4):475-82.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will report results relating to feasibility outcomes, which does not involve statistical tests. Secondary analyses will involve data pertaining to children’s performance on tasks of ToM and social competence. Descriptive statistics on secondary outcomes will be inspected for individual participants to identify trends in performance. Visual analysis, which involves visual inspection of graphically presented data from the baseline through to follow-up phase, will be used to identify trends. Visual analysis is a method commonly used in case studies, which avoids some of the difficulties associated with underpowered statistical tests in both case series and pilot designs (Smith, 2012). For visual analysis to be considered valid and reliable, a double baseline design is required at a minimum (Smith, 2012). In the current study, a double baseline approach will be taken for ToM, and multiple baselines will be taken for selected measures of social competence. Visual inspection has been chosen as it is considered the most appropriate and adept method for assessing change in interventions that involve a test of within-subjects effects. While new quantitative methods have been devised to estimate effect sizes in case studies, these are still only considered adjuncts to visual inspection (Lenz, 2013). Moreover, Arnold et al. (2009) advise against use of quantitative effect-size estimates when reporting treatment effects for pilot trials, stating that statistical tests should be avoided to prevent over-interpretation of results from underpowered statistical tests, which may reflect false positives due to imbalances in baseline patient characteristics or random variation in data (Thabane et al., 2010). As a result, visual inspection with use of simple, descriptive statistics were considered the most appropriate method for the current study. Both primary and secondary analyses will be used to draw a conclusion about whether the pilot protocol should be expanded into a larger scale trial. Participants who are included in the pilot trial will not be included in a further study to reduce the potential for bias in results.

Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ. The design and interpretation of pilot trials in clinical research in critical care. Critical care medicine. 2009;37(1):S69-S74.

Lenz A. Calculating effect size in single-case research: A comparison of nonoverlap methods. Measurement and Evaluation in Counseling and Development. 2013;46(1):64-73.

Smith J. Single-case experimental designs: A systematic review of published research and current standards. Psychological methods. 2012;17(4):510.

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC medical research methodology. 2010;10(1):1.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10787 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 22526 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 299325 0
Self funded/Unfunded
Name [1] 299325 0
Country [1] 299325 0
Primary sponsor type
Individual
Name
Associate Professor Suncica Lah
Address
Brain and Mind Centre, School of Psychology, University of Sydney. Level 3, 94 - 100 Mallett Street, Camperdown, Sydney, NSW, Australia, 2040.
Country
Australia
Secondary sponsor category [1] 298593 0
None
Name [1] 298593 0
Address [1] 298593 0
Country [1] 298593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300232 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 300232 0
Ethics committee country [1] 300232 0
Australia
Date submitted for ethics approval [1] 300232 0
16/02/2018
Approval date [1] 300232 0
15/03/2018
Ethics approval number [1] 300232 0
HREC/18/SCHN/21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82998 0
A/Prof Suncica Lah
Address 82998 0
School of Psychology, University of Sydney, Level 3, 94 - 100 Mallett Street Camperdown, Sydney, NSW, Australia, 2040.
Country 82998 0
Australia
Phone 82998 0
+61 (02) 9351 2648
Fax 82998 0
Email 82998 0
[email protected]
Contact person for public queries
Name 82999 0
Suncica Lah
Address 82999 0
School of Psychology, University of Sydney, Level 3, 94 - 100 Mallett Street Camperdown, Sydney, NSW, Australia, 2040.
Country 82999 0
Australia
Phone 82999 0
+61 (02) 9351 2648
Fax 82999 0
Email 82999 0
[email protected]
Contact person for scientific queries
Name 83000 0
Suncica Lah
Address 83000 0
School of Psychology, University of Sydney, Level 3, 94 - 100 Mallett Street Camperdown, Sydney, NSW, Australia, 2040.
Country 83000 0
Australia
Phone 83000 0
+61 (02) 9351 2648
Fax 83000 0
Email 83000 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA novel cognitive behavioural intervention with Theory of Mind (ToM) training for children with epilepsy: Protocol for a case series feasibility study.2019https://dx.doi.org/10.1186/s40814-019-0393-x
N.B. These documents automatically identified may not have been verified by the study sponsor.