None listed
Conditions
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.
Interventions
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 (correct
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.
Sponsors
Murdoch Childrens Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Days to No maximum
Healthy volunteers
No
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.
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).
Outcome results
None listed