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Trial registered on ANZCTR


Registration number
ACTRN12614000453684
Ethics application status
Approved
Date submitted
24/04/2014
Date registered
1/05/2014
Date last updated
11/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cluster randomised controlled trial of an occupational therapy group intervention for children designed to promote emotional wellbeing.
Scientific title
Cluster randomised controlled trial of an indicated occupational therapy group intervention for children aged 11­-13 years, designed to reduce symptoms of anxiety and depression and improve self­-esteem and participation
Secondary ID [1] 284219 0
Nil
Universal Trial Number (UTN)
U1111­1147­6005
Trial acronym
CRCTKPtH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health promotion
291329 0
Anxiety
291394 0
Depression
291395 0
Self-esteem
291396 0
Performance of occupations
291397 0
Life satisfaction and wellbeing 291398 0
Condition category
Condition code
Mental Health 291685 291685 0 0
Anxiety
Mental Health 291686 291686 0 0
Depression
Mental Health 291687 291687 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be evaluated is Kia Piki te Hauora (KPtH: Uplifting our Wellbeing). KPtH is 1x1 hour/week for 8 weeks, school-based, indicated occupational therapy group programme for children aged 11-13 years, designed to reduce symptoms of anxiety and depression, promote self-esteem, and increase occupational participation.

The intervention being studied is a manualised, indicated occupational therapy group intervention. Through engaging participants in developmentally appropriate activities the intervention is designed to promote mental health and wellbeing by enabling students to understand the relationship between what they do and how they feel/think; how activities they engage in influence their identity, self-concept, health and wellbeing; to practice and develop strategies for overcoming difficult emotions; and to apply this knowledge in building and designing healthy routines, behaviours and habits in their day-to-day life that support self-esteem and participation. Group activities are didactic (e.g. occupational analysis, fight-or-flight, relaxation techniques), involve peer exchange (e.g. occupational charades, brainstorming), direct experience (e.g. relaxation, games) and personal exploration (e.g. occupational analysis, pepeha , activity scheduling).
Intervention code [1] 288920 0
Prevention
Intervention code [2] 289267 0
Behaviour
Comparator / control treatment
Waiting list/No intervention: this group will then crossover into the intervention group and receive the intervention 2 weeks after the wait-list condition has ended.
Control group
Active

Outcomes
Primary outcome [1] 291640 0
Anxiety - child rated, measured using Multidimensional Anxiety Scale for Children - short form (MASC-10).
Timepoint [1] 291640 0
Post intervention (one week after completion of the 8 week intervention).
Secondary outcome [1] 307212 0
a) Anxiety - parent and teacher rated, measured using the Revised Child Anxiety and Depression Scale - Parent Short form (RCADS-PSF) and the School Anxiety Scale (SAS).

b) Anxiety - child rated, measured using Multidimensional Anxiety Scale for Children - short form (MASC-10).
Timepoint [1] 307212 0
a) Post intervention (one week after completion of the 8 week intervention) and 8-9 weeks later, at follow up.

b) 8-9 weeks after post intervention, at follow up.
Secondary outcome [2] 307213 0
Depression - child and parent rated, measured using Child Depression Inventory-2 (CDI-2) and the Revised Child Anxiety and Depression Scale - Parent Short form (RCADS-PSF).
Timepoint [2] 307213 0
Post intervention (one week after completion of the 8 week intervention) and 8-9 weeks later, at follow up.
Secondary outcome [3] 307214 0
Self-esteem - child and parent rated, measured using the Rosenberg Self-Esteem Scale (RSES) and the Single Item Self-Esteem Scale (SISES).
Timepoint [3] 307214 0
Post intervention (one week after completion of the 8 week intervention) and 8-9 weeks later, at follow up.
Secondary outcome [4] 307215 0
Performance in daily activities - child and parent rated, measured using the Canadian Occupational Performance Measure - modified.
Timepoint [4] 307215 0
Post intervention (one week after completion of the 8 week intervention) and 8-9 weeks later, at follow up.
Secondary outcome [5] 307216 0
Wellbeing and life satisfaction - child rated, measured using a self-titled 5-item questionnaire.
Timepoint [5] 307216 0
Post intervention (one week after completion of the 8 week intervention) and 8-9 weeks later, at follow up.

Eligibility
Key inclusion criteria
Schools
*Provide education to Years 7 & 8
*Located in Auckland region
*Principal consents for school to participate

Participants
*Aged 10-13 years
*Child assents and parent consents to participate
*Some signs of anxiety, depression, low self-esteem or disrupted participation in typical occupations present as identified by school personnel
Minimum age
10 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools
*Provides education exclusively for special needs group
*Not located in Auckland Region mainland

Participants
*Reporting para/suicidal intent warranting referral on to secondary services
*Unable to converse in basic English
*Has an identified Intellectual Disability

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)
Senior staff from eligible schools will be offered a meeting with the lead researcher to explain the study process, review the Participant Information Sheet: School Version and obtain consent. This process will be repeated until 14 schools are recruited across the stratum. Schools will be stratified by decile grouping (low, medium, and high) and allocated unique identifiers. For the 14 schools recruited to this study stratification can be understood as four schools from deciles 1-3, six schools from deciles 4-7, and four schools from deciles 8-10.

An indicated sample of 10-12 students at each of the enrolled schools will be recruited by senior staff from the school (e.g. Special Education Needs Co-Ordinator (SENCO), Principal). An indicated sample is those children presenting with some signs of anxiety or depression, low self-esteem or poor participation in typical occupations. Once participants have consented/assented to participate they will be assessed for eligibility. Participants will be screened using the Screen for Child Anxiety Related Disorders (SCARED) (Birmaher, 1999).

After eligibility screening is complete schools will be randomly allocated to one of the two study arms: (intervention or control) according to a computer-generated random number list held by a statistician unaware of the cluster-identifiers. The lead researcher will then advise the school which arm of the study they have been allocated to, in order to facilitate logistical aspects of arranging times and venues for the group to be held. Individual participants will not be informed of how they have been allocated until they have completed the baseline outcome measures. Further concealment is impractical due to the nature of the complex intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clusters will be randomly allocated to one of the two study arms (intervention or waitlist control) according to a computer-generated random number list held by a statistician unaware of the cluster-identifiers.

Schools will be stratified by decile grouping (low, medium, and high) and allocated unique identifiers. For the 14 schools recruited to this study stratification can be understood as four schools from deciles 1-3, six schools from deciles 4-7, and four schools from deciles 8-10.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Parallel component of the trial will include all participants as initially randomised to one of the two arms of the trial: intervention or Waitlist Control.

Crossover component will be included as secondary analysis will include the data from participants in the Waitlist Control group who later cross over into the Intervention group.

Outcome measures will be taken by a research assistant blinded to the treatment allocation of each cluster. However, given the outcome measures are self-, parent- or teacher-rated the individuals completing the measures will not be blinded to treatment allocation, except at baseline.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size
The sample size requirement for this study is 63 per study arm, a total of 126 children from 14 schools. This calculation is based on a sample size requirement for an individually randomised trial of 64, adjusted by a DE for clustering and analysis by ANCOVA of 0.98, and resulting in an ESS of 64. A target sample of 154 participants will be recruited to allow for possible 10% attrition.

ITT approach
As a pragmatic trial this study will utilise an ITT approach to analysis. The result is that data from all participants are used regardless of adherence to treatment allocation as this more accurately reflects real-life conditions.

Data analysis plan
A Repeated Measures Analysis of Covariance (RM-ANCOVA) approach to the data will allow comparisons of between-subject (intervention versus waitlist control) and within-subject (repeated measures on outcomes) factors and their interactions. Covariates can be incorporated into analysis through a regression model with an appropriate adjustment for clustering, such as a RM-ANCOVA. This approach will increase the power or sensitivity of the F-test and increase the likelihood of being able to detect differences between the groups, while also controlling for the increased number of comparisons and reducing the likelihood of Type I error (Pallant, 2010).

Two predetermined covariates will be specified for this study:
*Baseline scores on outcome measures
*Time from baseline to assessment (treated as categorical data) for repeated measures analyses

Additional covariates will be considered following a blind review by an independent statistician to determine if other factors are significant (e.g. decile rank, gender etc). The decision to include additional covariates will be the result of a blind review and secondary to their allocation, as they are derived from baseline data unaffected by the Independent Variable.

Planned comparisons, also known as a priori, will be performed to test the hypotheses of this study. Given the need to make multiple comparisons for the secondary hypotheses, the False Discovery Rate Control (FDRC) will be applied to protect against Type I errors.

Blind review
An independent statistician will review treatment data without knowledge of treatment allocation, prior to the final data analyses and after the data sets have been created. This is to finalise the statistical plan. The review will have scope to change three components of the statistical plan: any additional covariates that may be included in the final analyses to enhance efficiency; transformations required or the selection of other models; and management of missing data.

Missing data
This study will utilise multiple imputation for missing values and a logistical regression analysis of missing data characteristics from baseline outcomes to assess for any systematic patterns in missing data.

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 5878 0
New Zealand
State/province [1] 5878 0
Auckland

Funding & Sponsors
Funding source category [1] 288855 0
University
Name [1] 288855 0
AUT Vice Chancellor Doctoral Scholarship
Address [1] 288855 0
Auckland University of Technology,
90 Akoranga Drive
Northcote
Auckland 0627
Country [1] 288855 0
New Zealand
Primary sponsor type
Individual
Name
Ema Tokolahi
Address
Room AB114
Centre for Person-Centred Research
AUT University, Private Bag 92006
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 287551 0
Charities/Societies/Foundations
Name [1] 287551 0
Oakley Mental Health Foundation
Address [1] 287551 0
PO Box 68323, Newton, Auckland, 1145
Country [1] 287551 0
New Zealand
Secondary sponsor category [2] 296242 0
Government body
Name [2] 296242 0
Lotteries Health Research
Address [2] 296242 0
The Department of Internal Affairs
46 Waring Taylor Street
WELLINGTON 6011
PO Box 805
WELLINGTON 6140
Country [2] 296242 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290722 0
Health and Disabilities Ethics Committee (HDEC)
Ethics committee address [1] 290722 0
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 290722 0
New Zealand
Date submitted for ethics approval [1] 290722 0
30/01/2014
Approval date [1] 290722 0
18/02/2014
Ethics approval number [1] 290722 0
14/NTA/13
Ethics committee name [2] 290723 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [2] 290723 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
New Zealand
Ethics committee country [2] 290723 0
New Zealand
Date submitted for ethics approval [2] 290723 0
17/03/2014
Approval date [2] 290723 0
07/04/2014
Ethics approval number [2] 290723 0
14/75

Summary
Brief summary
The intervention to be evaluated is Kia Piki te Hauora (KPtH: Uplifting our Wellbeing). KPtH is an 8 week school-based group programme for children aged 11-13 years, designed to reduce symptoms of anxiety and depression, promote self-esteem, and increase occupational participation.

Question: "Is the intervention (KPtH) effective at reducing risk factors (symptoms of anxiety and depression) and increasing protective factors (self-esteem and participation), thus promoting future mental well-being, in children aged 11-13 years?"

Objectives
1) To compare change in outcome measures between intervention and waitlist-control.
2) To compare change in outcome measures between post-intervention and 8 weeks follow-up.
3) To evaluate the relationship between knowledge change about occupations, health and wellbeing on all outcome measures.

Design: This pragmatic trial will cluster participants by schools. Schools will be randomly allocated to receive the intervention or waitlist control. Outcome assessors will be unaware of intervention allocation. Measures will be taken at baseline and post-intervention for intervention or waitlist control groups. Those allocated to the waitlist will later receive the intervention. Outcome measures will be repeated at an 8 week follow up. Primary measure: the Multidimensional Anxiety Scale for Children – short form. Secondary measures: the School Anxiety Scale, Depression Self-Rating Scale for Children, Revised Child Anxiety and Depression Scale – Parent report/short version, Rosenberg Self-Esteem Scale, Single Item Self-Esteem Scale, Canadian Occupational Performance Measure – modified, Wellbeing and life satisfaction questions and a survey evaluating participant knowledge.

Significance: Generating research on preventative interventions is important for the future of children in Aotearoa/New Zealand.
Trial website
Trial related presentations / publications
Tokolahi, E., Hocking, C., & Kersten, P. (2016). Development and content of a school-based occupational therapy intervention for promoting emotional wellbeing in children. Occupational Therapy in Mental Health (Accepted – in press).

Tokolahi, E., Hocking, C., Kersten, P., & Vandal, A.C. (2016). Quality and reporting of cluster randomised controlled trials evaluating occupational therapy interventions: A systematic review. OTJR: Occupation, Participation and Health, (Accepted – in press).

Tokolahi, E., Hocking, C., Kersten, P., & Vandal, A.C. (2014). Cluster-randomised controlled trial of an occupational therapy group intervention for children designed to promote emotional wellbeing: Study protocol. BMC Psychology, 2(16).
Public notes

Contacts
Principal investigator
Name 46766 0
Mrs Ema Tokolahi
Address 46766 0
Room AB114
Centre for Person-Centred Research
AUT University, Private Bag 92006
Auckland 1142, New Zealand
Country 46766 0
New Zealand
Phone 46766 0
+64(0)2102315654
Fax 46766 0
Email 46766 0
etokolah@aut.ac.nz
Contact person for public queries
Name 46767 0
Mrs Ema Tokolahi
Address 46767 0
Room AB114
Centre for Person-Centred Research
AUT University, Private Bag 92006
Auckland 1142, New Zealand
Country 46767 0
New Zealand
Phone 46767 0
+64(0)2102315654
Fax 46767 0
Email 46767 0
etokolah@aut.ac.nz
Contact person for scientific queries
Name 46768 0
Mrs Ema Tokolahi
Address 46768 0
Room AB114
Centre for Person-Centred Research
AUT University, Private Bag 92006
Auckland 1142, New Zealand
Country 46768 0
New Zealand
Phone 46768 0
+64(0)2102315654
Fax 46768 0
Email 46768 0
etokolah@aut.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary