Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000362796
Ethics application status
Approved
Date submitted
4/01/2022
Date registered
1/03/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
1/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Longitudinal Study of Teenagers with Endometriosis, Period and Pelvic Pain in Australia (LongSTEPPP)
Scientific title
An observational longitudinal study of young people aged 10 to 18-years in Australia that tracks young people’s development and trajectories of period and pelvic pain, and endometriosis with current gynaecological care to determine factors associated with pain, quality of life, mental health and health utilisation.
Secondary ID [1] 304944 0
None
Universal Trial Number (UTN)
Trial acronym
LongSTEPPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysmenorrhoea 323094 0
menstrual disorders 323095 0
pelvic pain
 323096 0
endometriosis 325072 0
depression 325073 0
anxiety 325074 0
personality disorders 325075 0
chronic pain 325076 0
Condition category
Condition code
Reproductive Health and Childbirth 320671 320671 0 0
Menstruation and menopause
Reproductive Health and Childbirth 320672 320672 0 0
Other reproductive health and childbirth disorders
Anaesthesiology 322186 322186 0 0
Pain management
Mental Health 322187 322187 0 0
Anxiety
Mental Health 322188 322188 0 0
Depression
Mental Health 322189 322189 0 0
Psychosis and personality disorders
Public Health 322190 322190 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Participants are asked to complete questionnaires at baseline and annually thereafter for up to 5 years (or until 31/12/2027). The questionnaires cover periods, pain, quality of life, depression, anxiety, personality traits and adverse childhood events. The number of questionnaires depends on the age of the participant and is detailed in the study protocol and accompanying PICFs.
-For child/young person the questionnaires for the research project will take around 45 minutes of the child’s time, per year.
-For parent/guardian the questionnaires for the research project will take around 30 minutes of your time, per year.
The mode of delivery for all questionnaires is via email for completion online.

Participants are also invited to participate in pain-orientated sensitivity testing (POST) which is performed face-to-face using a calibrated algometer. POST appointments take up to 30 minutes for both the child/young person and their parent/guardian.

Health care utilisation (for children/young people) will be assessed by data linkage to Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) data. This requires the participant or parent/guardian (depending on age) to complete a separate participant consent form for the release of Services Australia information.
Intervention code [1] 322491 0
Diagnosis / Prognosis
Intervention code [2] 322738 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328491 0
Pain – assessed using Periods survey, Paed ePPOC survey and results of Pain-Orientated Sensory Testing (POST) (if available)
- The Periods survey has been designed specifically for this study and is not a validated questionnaire nor readily available.
-Paediatric electronic Persistent Pain Outcomes Collaboration (ePPOC) is a licensed research data collection tool available at: https://www.uow.edu.au/ahsri/eppoc/
citation: University of Wollongong Australia. electronic persistent pain outcomes collaboration (ePPOC). Patient questionnaires. Wollongong: University of Wollongong; 2021.
- POST is performed using a calibrated algometer
Timepoint [1] 328491 0
1-year post enrolment
Primary outcome [2] 330295 0
QoL – assessed using Periods survey and the age-appropriate version of the Pediatric Quality of Life Inventory 4.0 (PedsQL).
-PaedsQL is a licensed research data collection tool. Research license purchased from custodians Mapi Research Trust.
Timepoint [2] 330295 0
1-year post enrolment
Secondary outcome [1] 399178 0
Adverse Childhood Events – assessed using child version of the ACE
- citation: Vink RM, van Dommelen P, van der Pal SM, et al. Self-reported adverse childhood experiences and quality of life among children in the two last grades of Dutch elementary education. Child Abuse Negl 2019; 95: 104051.
Timepoint [1] 399178 0
at enrolment
at 5-years post enrolment or study closure
Secondary outcome [2] 404406 0
Mental Health - Depression
-Patient Health Questionnaire-9 (PHQ-9)
Citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16(9): 606-13.
Timepoint [2] 404406 0
at enrolment
at 1, 2, 3, 4 and 5 years post-enrolment
Secondary outcome [3] 405612 0
Mental Health - Anxiety
-Generalised Anxiety Disorder Questionnaire (GAD-7)
Citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006; 166(10): 1092-7.
Timepoint [3] 405612 0
at enrolment
at 1, 2, 3, 4- and 5-years post-enrolment
Secondary outcome [4] 405613 0
Mental Health - Personality Disorders
-modified Dimensional Personality Symptom Item Poll (DIPSI)
a shortened version of the DIPSI maladaptive trait measure for children and adolescents containing 16 items provided by Professor Barbara De Clercq
Citations: De Clercq B, De Fruyt F, Van Leeuwen K, Mervielde I. The structure of maladaptive personality traits in childhood: a step toward an integrative developmental perspective for DSM-V. J Abnorm Psychol 2006; 115(4): 639-57.
Rouco V, Franssens R, De Clercq B. A brief version of the DIPSI maladaptive trait measure for children and adolescents. Psychol Assess 2021; 33(9): 880-9.
Timepoint [4] 405613 0
at enrolment
at 1, 2, 3, 4- and 5-years post-enrolment
Secondary outcome [5] 406970 0
Mental Health - Personality Disorders
-Level of Personality Functioning Scale – Brief Form (LPFS-BF)
Citation: Weekers LC, Hutsebaut J, Kamphuis JH. The Level of Personality Functioning Scale-Brief Form 2.0: Update of a brief instrument for assessing level of personality functioning. Personal Ment Health 2019; 13(1): 3-14.
Timepoint [5] 406970 0
at enrolment
at 1, 2, 3, 4- and 5-years post-enrolment
Secondary outcome [6] 406971 0
Health utilisation is assessed as a composite of Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) data.
Timepoint [6] 406971 0
Data will be collected at study closure and will be for the last 5 years (i.e. covering 2022-2027).

Eligibility
Key inclusion criteria
Each young person must meet all the following criteria to be enrolled in the LongSTEPPP study:
• Is between the ages of 10 and 18-years at enrolment
• Has seen a GP or has a referral to:
an endometriosis and pelvic pain GP clinic (EPPC)
a gynaecologist or paediatrician
for dysmenorrhoea, period, or pelvic pain, or suspected or proven endometriosis from another health clinician.
• Can read and understand English, with proficiency enough to understand the Participant Information Statements, make an informed decision about completing the questionnaires and has the ability to complete the questionnaires; and
• The young person and parent/guardian provide informed consent, or the young person demonstrates maturity and capacity to consent and provides informed consent (as a mature minor).


We will also be recruiting female parents/guardians of enrolled young people who must meet all the following criteria to be enrolled in the LongSTEPPP study:
• Can read and understand English, with proficiency enough to understand the Participant Information Statements, make an informed decision about completing the questionnaires and ability to complete the questionnaires; and
• Demonstrates maturity and capacity to consent and provides informed consent.
Minimum age
10 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from LongSTEPPP:
• Absent uterus (Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome or Androgen Insensitivity Syndrome
• Referral to a gynaecologist for oncofertility/fertility preservation
• Intellectual disability or global developmental delay.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed to obtain an overarching view of period, pelvic and endometriosis in participants and the characteristics of those that present with pain. We will use multivariate linear and logistic regression analysis to explore. Data will be analysed to describe pain, mental health and health utilisation outcomes controlling for relevant confounding factors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/07/2022
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
3500
Accrual to date
159
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21362 0
The Canberra Hospital - Garran
Recruitment hospital [2] 21363 0
Royal Hospital for Women - Randwick
Recruitment hospital [3] 21364 0
John Hunter Hospital - New Lambton
Recruitment hospital [4] 21365 0
Sydney Children's Hospital - Randwick
Recruitment hospital [5] 21367 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [6] 21368 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [7] 21373 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [8] 21374 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 21377 0
Frankston Hospital - Frankston
Recruitment hospital [10] 21379 0
Monash Children’s Hospital - Clayton
Recruitment hospital [11] 21380 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [12] 21428 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 36254 0
2605 - Garran
Recruitment postcode(s) [2] 36255 0
2031 - Randwick
Recruitment postcode(s) [3] 36256 0
2305 - New Lambton
Recruitment postcode(s) [4] 36258 0
2145 - Westmead
Recruitment postcode(s) [5] 36259 0
0810 - Tiwi
Recruitment postcode(s) [6] 36263 0
5006 - North Adelaide
Recruitment postcode(s) [7] 36264 0
7000 - Hobart
Recruitment postcode(s) [8] 36267 0
3199 - Frankston
Recruitment postcode(s) [9] 36268 0
3168 - Clayton
Recruitment postcode(s) [10] 36269 0
3052 - Parkville
Recruitment postcode(s) [11] 36329 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 309334 0
Government body
Name [1] 309334 0
Australian Government Department of Health
Country [1] 309334 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
The Royal Children's Hospital,
50 Flemington Road
Parkville
Victoria
3052
Country
Australia
Secondary sponsor category [1] 311577 0
None
Name [1] 311577 0
Address [1] 311577 0
Country [1] 311577 0
Other collaborator category [1] 282147 0
University
Name [1] 282147 0
Deakin University
Address [1] 282147 0
Professor Catherine Bennett
Chair in Epidemiology,
School of Health and Social Development
Faculty of Health
Deakin University
221 Burwood Highway
BURWOOD
Victoria
3125
Country [1] 282147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309152 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 309152 0
Ethics committee country [1] 309152 0
Australia
Date submitted for ethics approval [1] 309152 0
15/01/2021
Approval date [1] 309152 0
15/02/2022
Ethics approval number [1] 309152 0
69173

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

Contacts
Principal investigator
Name 113166 0
Prof Sonia Grover
Address 113166 0
The Royal Children's Hospital Melbourne
3 West Clinical Offices
50 Flemington Road
Parkville
3052
VIC
Country 113166 0
Australia
Phone 113166 0
+61 03 9345 5800
Fax 113166 0
61 03 9345 5034
Email 113166 0
[email protected]
Contact person for public queries
Name 113167 0
Courtney Munro
Address 113167 0
5th Floor
Reproductive Development
Murdoch Children's Research Institute
50 Flemington Road
Parkville
3052
VIC
Country 113167 0
Australia
Phone 113167 0
+61 03 9936 6238
Fax 113167 0
Email 113167 0
[email protected]
Contact person for scientific queries
Name 113168 0
Courtney Munro
Address 113168 0
Health Services and Economics, Population Health, Murdoch Children’s Research Institute
50 Flemington Road Parkville 3052 VIC
Country 113168 0
Australia
Phone 113168 0
+61 03 9936 6238
Fax 113168 0
Email 113168 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14488Study protocol    To be published.
14489Statistical analysis plan    Available via request from PI and with CI consent.
14490Informed consent form    Available via request to the contact person and wi... [More Details]
14491Ethical approval    Available via a request to the contact person and ... [More Details]



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.