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Trial registered on ANZCTR


Registration number
ACTRN12622001499774
Ethics application status
Approved
Date submitted
18/11/2022
Date registered
30/11/2022
Date last updated
15/09/2024
Date data sharing statement initially provided
30/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating the Health Literacy Survey (HLS)-Child-Q15 tool in English to assess paediatric health Literacy
Scientific title
VITAL- Validation of Health Literacy Survey (HLS)-Child-Q15 In English, a Tool to Assess paediatric health Literacy
Secondary ID [1] 308302 0
None
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Health 328242 0
Public Health 328243 0
Condition category
Condition code
Public Health 325292 325292 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study has 3 stages:
Stage 1: The Formal translation of the HLS-Child-Q15 health literacy tool into English. This stage will take 1 month approximately.
Stage 2: Conduct a qualitative pre-test of the translated items. This stage will take approximately 2 months.
Stage 3: Validate the English translation of the HLS-Child-Q15 health literacy tool. This stage will take approximately 9 months.

Stage 1 – Translation
While an existing English translation of the HLS-Child-Q15 was published with the initial German version, this translation was not done according to a rigorous process for conceptual equivalence. Our translation methods are based on those published by Sousa & Rojjanasrirat in 2011. The steps below may need to be revisited if major discrepancies occur in translation.

Forward Translation
An initial English translation has been published by the authors of the German validation. The original German-language items of the HLS-Child-Q15 will be retranslated by a health professional who is fluent in German but also a native English speaker as per guidelines for the translation of instruments. The translator will not be provided with the previously published English translation. The translator will be instructed to aim for conceptual equivalence rather than literal word-for-word translation.

Expert Panel
A panel consisting of members of the research team including both native English and native German speakers will deliberate over the translations to identify and resolve any inadequate expressions or inconsistencies. The Forward Translation will be compared to the translated items reported in the English-language publication of the original validation of the HLS-Child-Q15. Discrepancies will be resolved by consensus of the team.

Back-Translation
The consensus translation will then be translated from English back to German by a health professional who is a native German speaker. This is to ensure the conceptual integrity of the items is retained throughout translation. Discrepancies from the original items will be examined and, if necessary, the translated items will be revised.

Stage 2 – Qualitative Pre-Test
In order to ensure that the translated questionnaire is suitable for the target population, we will conduct a qualitative pre-test and cognitive debrief. In doing so we will ensure that the items are understood by children, and that the received meaning is the same as in intended meaning for each item. The outcomes of the pre-test may require that the questionnaire items are adjusted prior to validation of the tool.
Children and parents will be recruited at Perth Children’s Hospital.
Recruited participants will be asked to complete a semi-structured interview lasting approximately 15 minutes, conducted by a trained member of the research team. Interviews will be audio recorded for subsequent transcription. Interviews will take place in an appropriate private space within the wards of Perth Children's Hospitals.
The interview will include collection of demographics for children (age, gender). The items of the translated HLS-Child-Q15 health literacy tool will be administered. The time taken to do so will be recorded. The remainder of the interview will consist of debriefing each item of the tool following the Interview Guide.
There is no other activity or treatment involved in participation in this study.

Translation Refinement
The results of the qualitative pre-test will be used to assess the items of the translated questionnaire, and if deemed necessary modifications will be made to the items. These changes will be made by consensus of the research team.

Stage 3 - Validation
Following translation and qualitative pre-testing the tool will be subject to validation of psychometric properties, and test-retest reliability will be assessed in an opt-in subset of participants. Children and parents will be recruited from all areas of Perth Children’s Hospital.
Recruited participants will be asked to complete an online questionnaire. This study will use the REDCap e-consent framework to provide study information and collect consent for participation. Participants will be able to self-enrol in the study via a poster with QR codes, or may be approached to participate by the study team. The online survey will close after 200 participants successfully complete the full questionnaire.
The questionnaire will include collection of demographics (age, gender), school year, primary caregiver’s highest education attainment, the Home Literacy Environment (HLE) single-item measure (number of children’s books in the home), and each item of the translated HLS-Child-Q15. Three questions designed to measure self-efficacy (“I can trust in my knowledge and abilities,” “I can find a solution for most problems,” and “If I make an effort, I will succeed”, measured on a four-point scale of agreement) will also be included in the online questionnaire. The questionnaire should take approximately 10 to 15 minutes.
To assess test-retest reliability (the consistency of HLS-Child-Q15 scores for the same child over time), responding parents will optionally be able to consent to a follow-up survey and provide their email address or phone number. These participants will automatically be sent a follow-up survey after 2 weeks containing each item of the translated HLS-Child-Q15. There will be a separate option to opt-in and provide an email address to receive a lay summary of findings at the conclusions of the research.
There is no other activity or treatment involved in participation in this study.

We anticipate that the project will be completed within 12 months, with an additional 3 months for data analysis and manuscript preparation.
Intervention code [1] 324892 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333154 0
The internal consistency of the translated HLS-Child-Q15-EN as measured by Cronbach’s alpha.
Timepoint [1] 333154 0
By study end date which is anticipated to be 15 months.
Primary outcome [2] 333156 0
The internal consistency of the scale and the test-retest reliability of the translated HLS-Child-Q15 tool.
Timepoint [2] 333156 0
By study end date which is anticipated to be 15 months.
Secondary outcome [1] 415992 0
The test-retest reliability of the HLS-Child-Q15-EN as measured by the intraclass correlation coefficient (ICC).
Timepoint [1] 415992 0
By study end date which is anticipated to be 15 months.

Eligibility
Key inclusion criteria
Children and parents will be recruited at Perth Children’s Hospital. who are on the surgical short stay unit or in hospital wards.
Children aged 8 to 15 years, stratified into two age cohorts; 8 to <12 years and 12 to 15 years.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children or parents who are not able to understand sufficient English to agree to inclusion in the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Stage 2:
Recruitment will be 10 children.
We will stratify by age with 5 children in each of two groups;8 to <12 years and 12 to 15 years.

Stage 3:
It is recommended that the sample size for a scale validation is at least 10 responses per survey item, or a minimum 200 observations. The HLS-Child-Q15 has 15 items, so a sample size of 200 meets minimum sample size and exceeds the 10:1 respondent to item ratio. Recruitment will therefore be 200 children.
We will stratify by age with 100 children in each of two groups – 8 to <12 years and 12 to 15 years.
The required sample size for the 2 week test-retest subgroup, where each subject has two observations, depends greatly on an estimate of the value of the intraclass correlation coefficient (ICC). Since no previous validation of the HLS-Child-Q15 has assessed test-retest reliability, there are no existing estimates for the ICC. If 30 survey respondents opt to complete the follow-up survey, there will be 90% power at an ICC of 0.5, which we believe to be a conservative estimate, with the required sample size decreasing as the estimated ICC increases.

Analytical Methods
Analyses will be performed in R.8
Stage 1 – Translation
There will be no formal statistical analysis of this stage, although key issues that occur and are resolved during this process will be noted and discussed in any publication of the translated tool.
Stage 2 – Qualitative Pre-test
Demographics & Administration of Tool
Simple descriptive statistics will be performed on demographics and the time taken to administer the tool to participants.
Qualitative Debriefing
The interviews will be transcribed, and subject thematic analysis will be undertaken with the assistance of qualitative data analysis software (MAXQDA), following the Framework Method as outlined below.9
Transcription
Following each interview, the audio recording will be transcribed, and then imported into qualitative data management software (MAXQDA) for analysis. Where participants have specifically consented, audio recordings may be provided to a suitably qualified external agency for transcription by secure file transfer, in other cases the research team will perform the transcription internally.
Familiarisation with the interview
Three members of the research team will familiarise themselves with all interview transcripts by reading the transcripts.
Coding
Analyst triangulation will be used during the coding process. The first three transcripts will be firstly independently coded by three researchers and discrepancies will be discussed and reconciled as necessary through consensus. This will ensure multiple interpretations are captured and discussed, thereby increasing the richness and trustworthiness of the findings.
Developing a working analytical framework
After coding these initial transcripts, a working analytical framework will be developed, consisting of codes with associated definitions, which will be further refined as further transcripts are coded.
Applying the analytical framework
Each transcript will be coded based on the analytical framework. New codes and definitions added to the analytical framework will be discussed between members of the research team.
Charting data onto the framework matrix
Data from the coded transcripts will be charted onto a framework matrix, showing participant data for each code, including direct and/or summarised participant quotes. Codes will be tentatively grouped together according to emerging themes.
Interpreting the data
Final themes will be identified by mapping connections within and between participant responses, and making analytical memos for each theme identified.
Stage 3 – Validation
The number and proportion of participants who opened but did not complete the survey will be reported. Descriptive statistics will be performed on demographics and HLS-Child-Q15 items.
To assess how well participants were able to answer the HLS-Child-Q15 items, the proportion of “I don’t know” responses will be reported for each item in the scale, similarly to previous validation studies for this scale.5 The proportion of maximum agreement (proportion of selection of the maximum agreement response) will also be reported for each question as this has implications for the discriminatory power of the item.
Exploratory factor analysis will be performed on the translated HLS-Child-Q15 items to determine the factor structure, and Cronbach’s alpha will be reported as an assessment of the internal consistency of the scale,10 with a value of 0.70 or greater considered acceptable. Test-retest reliability will be assessed by calculating the intraclass correlation coefficient (ICC) for the subset of participants who respond to the follow-up repeat survey at two weeks. An ICC closer to 1.0 indicates higher reliability.
A linear regression analysis with the HLS-Child-Q15 total score as the outcome and the participant demographics (age, gender, primary caregiver’s highest educational attainment, Home Literacy Environment) as predictors will be performed to assess differentiation between known groups, an aspect of scale validity. We expect that the HLS-Child-Q15 scores will be higher for children who are older, who have higher HLE scores, or whose parents have higher educational attainment. We expect the score to be independent of gender. Correlation between the HLE and the HLS-Child-Q15 score will also indicate convergent validity, in that home literacy and health literacy are expected to be related concepts. To quantify discriminant validity, we will calculate Spearman’s rank-order correlation coefficient between the HLS-Child-Q15 score and the self-efficacy score; a weak to moderate correlation coefficient will indicate that the HLS-Child-Q15 and self-efficacy scores are measuring distinct concepts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/12/2022
Actual
3/04/2023
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
210
Accrual to date
101
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23483 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 38891 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312552 0
Hospital
Name [1] 312552 0
Perth Children's Hospital
Country [1] 312552 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service
Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 314154 0
None
Name [1] 314154 0
Address [1] 314154 0
Country [1] 314154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311879 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311879 0
Ethics committee country [1] 311879 0
Australia
Date submitted for ethics approval [1] 311879 0
20/09/2022
Approval date [1] 311879 0
26/10/2022
Ethics approval number [1] 311879 0
RGS0000005719

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

Contacts
Principal investigator
Name 122698 0
Prof Britta von Ungern-Sternberg
Address 122698 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122698 0
Australia
Phone 122698 0
+61 420790101
Fax 122698 0
Email 122698 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for public queries
Name 122699 0
Britta von Ungern-Sternberg
Address 122699 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122699 0
Australia
Phone 122699 0
+61 420790101
Fax 122699 0
Email 122699 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 122700 0
Britta von Ungern-Sternberg
Address 122700 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Country 122700 0
Australia
Phone 122700 0
+61 420790101
Fax 122700 0
Email 122700 0
Britta.Regli-VonUngern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan for this


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.