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Trial registered on ANZCTR


Registration number
ACTRN12617001596392
Ethics application status
Approved
Date submitted
10/11/2017
Date registered
1/12/2017
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent Education for Developmental Literacy (PEDaL) Pilot Study: Neonatal nursery education program for improving parent knowledge of infant development.
Scientific title
Parent Education for Developmental Literacy (PEDaL): Neonatal nursery parent education program for improving the developmental literacy of mothers and fathers of very preterm infants.
Secondary ID [1] 293209 0
None
Universal Trial Number (UTN)
Trial acronym
PEDaL pilot study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Developmental literacy in parents of very preterm infants 305213 0
Condition category
Condition code
Reproductive Health and Childbirth 304525 304525 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this pilot study is an internet based, neonatal nurse led parent education program to enhance developmental literacy following preterm birth.

Parents will be provided with education program materials from enrolment into the study, until the date of their first routine neonatal clinic appointment at 4-6 weeks post discharge.

Duration of the program will vary according to the gestational age and severity of illness of the baby. For example, parents of a baby born at 24 weeks' gestation will not be approached until the baby is clinically more stable between 27-30 weeks' post menstrual age (PMA). Duration of the program for this family would be approximately 16 weeks. In contrast, parents of a baby born at 32 weeks' gestation will be approached within 4 days of delivery. Duration of the program for this family would be approximately 8 weeks.

Parent Easy Guides from Parenting SA and SA Department of Education and Child Development (DECD) resources were used in the development of the PEDaL parent education program. Educational materials include 8 information sheets, 8 videos, a diary that contains hands on activities to do with the baby, 2 one on one education sessions, and links to 20 external websites. Content provided is specific to premature baby development, parenting premature babies, and perinatal mental health for mothers and fathers.

Parent use of the website and online resources contained within it is entirely self directed. Web resources can be accessed at any time of the day/night and parents decide how much time to spend using the website between enrolment and 4 weeks' post discharge from the Neonatal Nursery. Program dose and intensity will therefore vary between participants.

The infant development diary reinforces parent online learning with hands on activities that support premature baby development. It contains specific activities for parents to do together with their baby to cue them in to the unique and evolving developmental capacities of their infant, and their role in fostering this.

One on one education sessions will be delivered face to face by an experienced neonatal nurse. These sessions are planned to be personalised to the individual infant, and parents. Parents will be encouraged to ask questions specifically regarding the program, their baby's development and how they can support this. The first one on one session is 4 - 7 days after enrolment and is expected to take approx. 30 minutes. The second session occurs 4-7 days prior to discharge from the neonatal nursery. A Newborn Behaviour Observation (NBO) assessment will be included in this final session and is expected to take approx. 45 minutes to 1 hour.

Parent self-report will serve as an indicator of engagement with the educational content provided. Independent measures of program adherence and engagement will be collected by computer programming analytics built into the PEDaL website to track and record individual participant use during the program, and through study staff review of diary activity completion.








Intervention code [1] 299473 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303775 0
To obtain preliminary evidence for whether the PEDaL parent education program is effective in improving the developmental literacy of mothers and fathers of very preterm infants.
This will be assessed with the Parent Knowledge of Preterm Infant Behaviour (KPIB) questionnaire to determine change in developmental literacy.
Timepoint [1] 303775 0
At two time points:
1. At enrolment
2. At program completion, 4-6 weeks post discharge.
Primary outcome [2] 303847 0
To obtain preliminary evidence for whether the PEDaL parent education program is effective in improving the developmental literacy of mothers and fathers of very preterm infants via the Caregiver Knowledge of Child Development Inventory (CKCDI)
Timepoint [2] 303847 0
At two time points:
1. At enrolment
2. At program completion, 4-6 weeks post discharge.
Secondary outcome [1] 340118 0
To examine parent engagement with PEDaL education program resources.
This will be assessed via participant use of the website and online resources. Data will be captured using computer programming analytics built into the study website to obtain individual participant usage, and includes:
1. number of participants that logged onto the PEDaL website to access the program at least once
2. which video sessions were viewed, and when
3. whether the video was watched to the end
4. number of repeat views of each video
5. which PEDaL information documents were downloaded
6. which external websites were visited from the links provided on the study
website
7. how many times participants logged onto the study website during the program
8. the length of time (minutes) spent logged on to the study website during the program..
Timepoint [1] 340118 0
Computer programming analytics built into the PEDaL website will collect continually data during program delivery, commencing at enrolment through to program completion at 4-6 weeks post discharge.
Secondary outcome [2] 340119 0
To examine parent engagement with PEDaL education program resources via parent completion of infant diary activities.
Timepoint [2] 340119 0
At three time points:
1. At program commencement: 4 -7 days following enrolment.
2. 4 -7 days prior to discharge from the nursery
3. At program completion: 4 - 6 weeks post discharge from the neonatal nursery.
Secondary outcome [3] 340125 0
To examine parent level of engagement with PEDaL education program.
This will be assessed via attendance and participation in the face to face, one on one education sessions.
Timepoint [3] 340125 0
At two time points:
1. At program commencement: 4 -7 days following enrolment.
2. 4 -7 days prior to discharge from the nursery
Secondary outcome [4] 340126 0
To examine parent satisfaction with the PEDaL education program.
This will be assessed via parent satisfaction survey adapted from the Client Satisfaction Questionnaire (CSQ)

Timepoint [4] 340126 0
At program completion: 4 - 6 weeks post discharge from the neonatal nursery.

Secondary outcome [5] 340127 0
To establish whether the program influences parenting behaviour, specifically their sense competence and efficacy in the parenting role.
This will be assessed with the Parenting Sense of Competence Scale (PSOCS) .
Timepoint [5] 340127 0
At two time points:
1. At enrolment
2. At program completion 4-6 weeks post discharge from the neonatal nursery.

Secondary outcome [6] 340270 0
To acertain whether the program influences parent emotional health, specifically depressive symptoms.
This will be assessed with the Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [6] 340270 0
At two time points:
1. At enrolment
2. At program completion 4-6 weeks post discharge from the neonatal nursery.
Secondary outcome [7] 340271 0
To explore neonatal staff level of satisfaction with the PEDaL parent education program.
This will be assessed via a staff satisfaction questionnaire adapted from the Client Satisfaction Questionnaire (CSQ).
Timepoint [7] 340271 0
At study completion. After the final PEDaL participant family is discharged from the neonatal nursery.

Eligibility
Key inclusion criteria
Parents with an infant inborn at the Women's and Children's Hospital at less than 32 completed weeks' gestation and currently inpatient in the Neonatal Nursery.
Able to give informed consent.

Registered nurses and midwives, physiotherapists, doctors and social worker responsible for patient care delivery in the neonatal nursery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents with insufficient English to comprehend the study information sheet
Parents of triplets or higher order multiples
Parents of infants under the guardianship of the minister (GOM 18)
Parents of infants receiving palliative care
Parents of infants with a diagnosis of neonatal abstinence syndrome
Parents of infants with bilateral grade III intra-ventricular haemorrhage or higher, or gross neurological impairment.
Parents of infants with a congenital abnormality affecting neurodevelopment
Parents whom are unavailable to be involved in the care of their baby during admission.




Study design
Purpose of the study
Educational / counselling / training
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
Parents will only be approached and invited to participate in the study after their baby's most critical stage has passed and they have begun to recover from the shock of premature birth.

Neonatal nursery inpatient lists and dialogue with a consultant neonatologist, neonatal fellow or shift co-ordinator RN/RM on duty will be used to identify potential participants and to establish eligibility for the purpose of recruitment into the study.

When all the inclusion and exclusion criteria have been checked and the eligibility of the parent confirmed, they will be approached by the principal investigator and have the study explained to them. If they are interested in the study, a copy of the information sheet and consent form will be given to the parent.

The information sheet will describe the purpose of the study, what it involves and requires of them, the risks and benefits, and the right to decline or withdraw participation. The principal investigator will conduct the informed consent discussion and will check that parents understand the information provided answer any questions about the study. Consent will be voluntary and free from coercion.

Program fidelity is enhanced by the same research staff member conducting every individual face to face education session with participants during the study period. The staff member is an experienced neonatal nurse consultant and qualified NBO practitioner.

Parent self-report will serve as an indicator of engagement with the educational content provided. Independent measures of program adherence and acceptability will be collected by computer programming analytics built into the PEDaL website to track and record individual participant use during the study, and through study staff review of diary activity completion.

Staff satisfaction data will be collected from a multi-disciplinary team consisting of registered nurses and midwives, doctors, physiotherapists and social workers directly involved in the provision of patient care in the neonatal nursery. This will provide a more complete evaluation of the intervention than what would be possible if we included just one discipline.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Calculation:
There is no report of a parenting education intervention examining developmental literacy levels of parents with preterm newborns. As this is a pilot study, the sample size of 20 families and 20 multi-disciplinary neonatal nursery staff should be adequate to obtain preliminary data on program efficacy, acceptability and feasibility.

Each year, the Women's and Children's Hospital Neonatal Nursery admits an average of 145 infants born at less than 32 completed weeks' gestation. This is approximately 12 families each month. Our sample size calculation is based on a 50% recruitment rate. As such, our target is to enrol an average of 6 families per month into the study to achieve a parent participant sample size of 20 families.

The Neonatal Nursery employs approximately 190 neonatal nursing and midwifery staff,
1 social worker, 1 physiotherapist and 8 neonatal fellows or consultants. Not all will have direct involvement in the provision and support of parents in completing baby development diary activities during the study. The sample size of 20 multi-disciplinary staff is based upon a survey completion rate of 10%.

Statistical methods / analysis
Outcomes will be analysed using IBM SPSS for Windows software. All analyses will follow a pre-specified statistical analysis plan.

Primary outcome will be assessed by the statistical significance of any difference between pre and post-test levels. A series of ANCOVAs and MANCOVAs will be used to analyse program effects. Mean pre test to post test change will be calculated to determine effect sizes of the program. The same statistical analysis approach will be used to establish program effects upon parent post-natal depression rates and parenting sense of competence pre and post-test.

Parent and staff satisfaction with the program will be analysed using mean overall scores and standard deviation on the satisfaction questionnaires, and also by number and % for each question. Free text answers will be independently analysed by research staff to identify key content themes.




Recruitment
Recruitment status
Recruiting
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)
SA
Recruitment hospital [1] 9281 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 17944 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 297839 0
Charities/Societies/Foundations
Name [1] 297839 0
Women's and Children's Hospital Foundation
Address [1] 297839 0
72 King William Road
North Adelaide
South Australia 5006
Country [1] 297839 0
Australia
Funding source category [2] 297857 0
Other Collaborative groups
Name [2] 297857 0
Robinson Research Institute
Address [2] 297857 0
55 King William Road
North Adelaide
South Australia 5006
Country [2] 297857 0
Australia
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
Healthy Mothers Babies and Children theme,
72 King William Rd
North Adelaide
South Australia 5006
Country
Australia
Secondary sponsor category [1] 296893 0
None
Name [1] 296893 0
Address [1] 296893 0
Country [1] 296893 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298886 0
Womens and Childrens Health Network Human Research Ethics Committee
Ethics committee address [1] 298886 0
Level 2 Samuel Way Building
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 298886 0
Australia
Date submitted for ethics approval [1] 298886 0
16/06/2017
Approval date [1] 298886 0
25/08/2017
Ethics approval number [1] 298886 0
HREC/17/WCHN/101

Summary
Brief summary
There is a great deal of variability in neurodevelopmental outcomes for babies and children born very preterm. A number of antenatal and neonatal complications have been associated with increased risk for adverse neurodevelopmental sequelae. Yet currently there is a paucity of evidence surrounding the effect of parent developmental literacy as a protective enabler for optimal neurodevelopment following very preterm birth.

This pilot study seeks to address this knowledge gap by exploring whether a parent education program for mothers and fathers of very preterm infants is effective in improving parent developmental literacy. Our aim is to build practical evidence regarding PEDaL program efficacy, acceptability and feasibility that is specific to the Australian health care service.

The study setting is a large metropolitan Neonatal Nursery in South Australia, comprising intensive care and special care units. Sample size = 20 families with babies born at less than 32 completed weeks' gestation and 20 multi-disciplinary staff employed within the Neonatal Nursery. Recruitment period is 4 months.

Parent participants will undertake an education program designed to improve their understanding of their baby’s development, and how they can support this in the first months after preterm birth. The program begins early, whilst inpatient in the Neonatal Nursery, and continues until 4 – 6 weeks post discharge.

We will use a pre-test post-test study design. Primary outcome is parent developmental literacy. Secondary outcomes include parent sense of competence, parent mental health, program acceptability and satisfaction as assessed by parents and multi-disciplinary neonatal staff. Length of stay and infant readmission to hospital within 30 days of discharge are also secondary outcomes for the study.
Trial website
www.pedal.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78562 0
Mrs Megan Bater
Address 78562 0
SAHMRI, Healthy Mothers Babies and Children
Level 7 Reiger Building
72 King William Road
North Adelaide
South Australia 5006
Country 78562 0
Australia
Phone 78562 0
(+61) 08 8161 7000 pager 5739
Fax 78562 0
Email 78562 0
megan.bater@adelaide.edu.au
Contact person for public queries
Name 78563 0
Mrs Megan Bater
Address 78563 0
SAHMRI, Healthy Mothers Babies and Children
Level 7 Reiger Building
72 King William Road
North Adelaide
South Australia 5006
Country 78563 0
Australia
Phone 78563 0
(+61) 08 8161 7000 pager 5739
Fax 78563 0
Email 78563 0
megan.bater@adelaide.edu.au
Contact person for scientific queries
Name 78564 0
A/Prof Carmel Collins
Address 78564 0
SAHMRI, Healthy Mothers Babies and Children
Level 7 Reiger Building
72 King William Road
North Adelaide
South Australia 5006
Country 78564 0
Australia
Phone 78564 0
(+61) 08 8128 4409
Fax 78564 0
Email 78564 0
carmel.collins@sahmri.com

No data has been provided for results reporting
Summary results
Not applicable