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Trial registered on ANZCTR


Registration number
ACTRN12614000906651
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
26/08/2014
Date last updated
17/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving child and parent outcomes after preterm birth using a web-based early intervention program (e-prem)
Scientific title
In children born <34 weeks' gestational age, does a web-based intervention for parents (e-prem), compared with standard care, improve children's cognitive outcomes at age 2 years?
Secondary ID [1] 285168 0
Nil known
Universal Trial Number (UTN)
U1111-1160-3085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature birth 292759 0
Mental health problems 292761 0
Cognitive impairment 292762 0
Condition category
Condition code
Reproductive Health and Childbirth 293049 293049 0 0
Complications of newborn
Mental Health 293050 293050 0 0
Depression
Mental Health 293051 293051 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Families in the intervention arm of the study will participate in the "e-prem" intervention, which is a web-based program for families with infants born <34 weeks’ gestation. It is designed to promote child development and parental mental health by providing parents with skills, resources and information via a standardised yet flexible on-line program with one-on-one telephone coaching and counselling. e-prem has 8 age-dependent modules completed from birth to the child’s first birthday (corrected). Each module contains 5-10 individual content topics, each taking between 5-20 minutes to complete. It is anticipated that parents will spend approximately 30 mins each week completing modules for the first 2-3 months of the program. For the remainder of the program parents will spend approximately 1 hour per month completing modules. The focus of e-prem is on educating parents about preterm infant development, strengthening the parent-child relationship and supporting parental mental health, and the content has been informed by cognitive-behavioural and developmental care theories and evidence-based care. e-prem begins in the NICU and will be accessed by e-prem for between 14-16 months by each family depending on their infant’s birth gestation. The program includes weekly/fortnightly/monthly phone calls from the same e-prem clinician, where specific modules will be completed by parents and clinicians together over the phone, guided by the web-based material. This provides individualised contact and increased support over the course of the program, and will be guided by parent-reported current challenges or issues. Clinical contact occurs weekly for the first month of the program and fortnightly for the second month to support families through the initial adjustment phase. Contact is then monthly or as needed. The approximate duration of each clinical contact is 30 minutes. The first of these clinician guided sessions will occur face-to-face with parents in the NICU.
Intervention code [1] 290019 0
Prevention
Intervention code [2] 290020 0
Behaviour
Comparator / control treatment
Standard care for families with preterm infants, which means having a care manager for each family and potential for referral by hospital clinicians for additional support for parents or infant as appropriate. This referral may be for in-hospital support or external intervention.
Control group
Active

Outcomes
Primary outcome [1] 292922 0
Cognitive development standard score on the cognitive scale of the Bayley Scales of Infant Development III.
Timepoint [1] 292922 0
24 months' corrected age
Secondary outcome [1] 309950 0
Parent symptoms of depression and anxiety measured by the Centre for Epidemiologic Studies Depression Scale (CES-D) and the Generalised Anxiety Disorder-7 questionnaire.
Timepoint [1] 309950 0
24 months' corrected age
Secondary outcome [2] 309951 0
Child language scores on the Bayley Scale of Infant Development III and social-emotional development assessed using the Infant-toddler social-emotional assessment questionnaire.
Timepoint [2] 309951 0
24 months' corrected age
Secondary outcome [3] 309952 0
Parental quality of life assessed using the Assessment of Quality of Life (AQoL-8D).
Timepoint [3] 309952 0
24 months' corrected age
Secondary outcome [4] 310974 0
Parent-child relationship assessed using the Emotional Availability Scales.
Timepoint [4] 310974 0
24 months' corrected age

Eligibility
Key inclusion criteria
Infants born <34 weeks’ gestation and their mothers from the NICU at the Royal Women’s Hospital in Melbourne, Victoria (March 2015 to December 2016). Fathers/partners will also be invited to participate.
Minimum age
1 Days
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) infants with a known congenital or genetic abnormality known to adversely affect development, or (2) non-English speaking parents (parents need to be able to communicate effectively and read English due to the requirements of the English language web-based program).

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)
A study-specific research nurse will approach potentially eligible families within the first week after birth, following consultation with the treating medical team determining that the baby is medically stable and is appropriate for the study. The research nurse will explain the study and time commitment required, provide written information, and obtain written informed consent. Following the collection of baseline data, each family will be randomly allocated to either the intervention group or control group in a 1:1 ratio. The rate of multiples in preterm infants is high. Due to the nature of the intervention, families rather than infants will be randomised as all infants in the same household will need to be in the same group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation will be computer generated by an independent statistician using block randomisation with variable block sizes, stratified by multiple births. Group allocation will be determined using concealed envelopes, labelled with sequential numbers in each strata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We will cease recruitment at 100 participants, and will be mindful of possible limitations to power due to the smaller than anticipated sample.
All analyses will be performed on an intention-to-treat basis according to the caregiver’s randomised allocation. The primary outcome of Bayley-III cognitive standard score at 24 months’ will be compared between the groups using linear regression models fitted at the child level using generalised estimating equations (GEEs) to allow for the clustering of twins, and adjusted for multiple births used in the randomisation process. Secondary outcomes will be analysed using linear regression models for continuous outcomes and logistic regression models for binary outcomes, with analyses at the child level again fitted using GEEs. Regression model analyses at the family level (parent depression and anxiety) will not be fitted with GEEs, and will be repeated for mothers and partners in separate analyses. All results will be presented as differences in means or odds ratios between the two groups with 95% confidence intervals and 2-sided p-values. As a sensitivity analysis, analyses will also be presented adjusted for baseline parental depression and anxiety and social risk as potentially important confounders. Effects of the intervention on the parent-child relationship will be examined, and the parent-child relationship as a mediator of child outcomes at 24 months. The program costs and health care expenditures will be combined to calculate the total costs of intervention and control. Incremental cost effectiveness ratios (ICERs) for e-prem vs standard care will be calculated per 0.3 SD increase in cognitive outcome and per maternal QALY gained at 12 and 24 months (calculated from utility scores measured with the AQoL-8D). All analyses will be performed according to a pre-specified statistical analysis plan.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2855 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 8544 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 289779 0
Self funded/Unfunded
Name [1] 289779 0
Address [1] 289779 0
Country [1] 289779 0
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Childrens Research Institute
Address
RCH, Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 288469 0
None
Name [1] 288469 0
Address [1] 288469 0
Country [1] 288469 0
Other collaborator category [1] 278096 0
Hospital
Name [1] 278096 0
Royal Women's Hospital
Address [1] 278096 0
Flemington Rd, Parkville, VIC 3052
Country [1] 278096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291509 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 291509 0
Royal Women's Hospital, Flemington Rd, Parkville, VIC 3052
Ethics committee country [1] 291509 0
Australia
Date submitted for ethics approval [1] 291509 0
16/09/2014
Approval date [1] 291509 0
19/12/2014
Ethics approval number [1] 291509 0

Summary
Brief summary
Preterm birth (<34 weeks’ gestation) increases the risk for impairments in physical, mental health and academic functioning in children compared with term controls, with approximately 50% of preterm children affected. An estimated 40% of mothers of preterm infants report significant symptoms of depression, and many parents report an ongoing negative influence of preterm birth on family functioning. This important pilot study will evaluate the efficacy of the first web based intervention designed to promote child development and parental mental health for parents with infants born <34 weeks’ gestation. The primary aim of this randomised controlled trial is to assess the efficacy of a web-based intervention (e-prem) compared with standard care on child cognitive development at 24 months’ corrected age. Secondary outcomes of child behaviour and parent mental health will be compared between groups. e-prem is a web-based program with age-dependent content completed by parents from birth (starting in the neonatal intensive care unit) to the child’s first birthday (corrected). The program includes activities, resources, and an individualised fortnightly-monthly session over the phone. This study will recruit 100 infants born <34 weeks’ gestation (and their primary caregivers) from the Royal Women’s Hospital in Melbourne, Victoria. Families will be randomly allocated to either the intervention group and participate in the e-prem program, or control group and receive standard care. Child cognitive development will be assessed at 24 months’ corrected age. Primary caregivers will complete questionnaires on symptoms of anxiety and depression at recruitment, when infants are 12 months’ corrected age (post-intervention), and 24 months’ corrected age. Primary caregivers will complete questionnaires on child social-emotional development at 24 months’ corrected age. The parent-child relationship will be assessed at 12 months' corrected age. Program costs will be calculated. Outcomes will be compared between intervention and control groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50694 0
Dr Karli Treyvaud
Address 50694 0
VIBeS group, Murdoch Childrens Research Institute
RCH, Flemington Rd, Parkville, VIC 3052
Country 50694 0
Australia
Phone 50694 0
+61 3 9936 6719
Fax 50694 0
Email 50694 0
karli.treyvaud@mcri.edu.au
Contact person for public queries
Name 50695 0
Dr Karli Treyvaud
Address 50695 0
VIBeS group, Murdoch Childrens Research Institute
RCH, Flemington Rd, Parkville, VIC 3052
Country 50695 0
Australia
Phone 50695 0
+61 3 9936 6719
Fax 50695 0
Email 50695 0
karli.treyvaud@mcri.edu.au
Contact person for scientific queries
Name 50696 0
Dr Karli Treyvaud
Address 50696 0
VIBeS group, Murdoch Childrens Research Institute
RCH, Flemington Rd, Parkville, VIC 3052
Country 50696 0
Australia
Phone 50696 0
+61 3 9936 6719
Fax 50696 0
Email 50696 0
karli.treyvaud@mcri.edu.au

No data has been provided for results reporting
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