None listed
Conditions
Brief summary
Parents with babies in the neonatal intensive care unit (NICU) have significantly higher risks of developing anxiety, depression, and acute stress disorders than the general postpartum population. The NICU experience may also disrupt parent-infant bonding and lead to long-term negative effects including impaired parenting and early childhood socio-emotional problems. Maori parents and caregivers may be at even higher risk of these negative impacts, as they have endured persistent perinatal health disparities (higher rates of preterm birth and maternal mortality) for decades due to Aotearoa’s history of colonization and societal inequalities. Internationally, clinicians and researchers have developed a range of psychosocial interventions to reduce distress levels of NICU parents, including family-centred interventions and psychological interventions adapted for the NICU. While these interventions can be effective, many are time-intensive for staff and participants and costly to deliver. A recent survey of services found that these types of interventions are not in use in Aotearoa New Zealand, likely because NICUs have significant resource constraints to support parents. In an ongoing qualitative study we are conducting with Maori and non-Maori NICU parents, whanau/extended family, and clinicians at Starship Child Health NICU in Auckland, New Zealand, initial analysis indicates that the majority of parent participants reported that they wanted more educational information throughout their baby’s admission, as they felt “confused” and “in the dark” about many aspects of the NICU, including common medical procedures their babies were likely to experience and medical terminology used by the staff. Many participants and clinicians also felt teaching parents and caregivers culturally appropriate stress reduction strategies would be highly beneficial to reduce distress. Acceptance and Commitment Therapy (ACT), an evidence-based form of psychological therapy that incorporates mindfulness and values-oriented behavioural change and focuses on increasing psychological flexibility, may address these needs. ACT has been shown to be effective in reducing distress and improving wellbeing in a range of populations, including parents of children with chronic illnesses, particularly when combined with parent education. Importantly for the Aotearoa New Zealand NICU context, studies have also found ACT can be effectively delivered digitally and in brief format. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test its utility with this population. Therefore, we will use a three-armed, cluster randomised controlled trial design to evaluate the difference in effect between an online ACT plus education intervention, an online education-only intervention, and standard care. Our hypothesis is that the ACT plus education intervention will reduce stress more than the other two groups.
Interventions
A three-armed, single-centre, cluster randomised controlled trial will be used to compare an online Acceptance and Commitment Therapy (ACT) plus education intervention with an online education-only intervention and standard care. The interventions will be delivered online and undertaken over 2 weeks.
Potential participants will be introduced to the study by clinicians in the NICU and, with participant consent, contacted by a member of the research team. A research team member will provide inte
A three-armed, single-centre, cluster randomised controlled trial will be used to compare an online Acceptance and Commitment Therapy (ACT) plus education intervention with an online education-only intervention and standard care. The interventions will be delivered online and undertaken over 2 weeks. Potential participants will be introduced to the study by clinicians in the NICU and, with participant consent, contacted by a member of the research team. A research team member will provide interested participants with a link to REDCap (a secure web application for managing online surveys and databases) to review the Participant Information Sheet (which will be available for download), read and complete an online screening questionnaire for eligibility. If eligible for the study, participants will complete an online consent form and then fill out baseline questionnaires on REDCap. Upon completion of the consent form and baseline questionnaires on REDCap, participants will be randomised into one of three groups by a computer randomisation programme (delivered via REDCap). Group 1: ACT plus education intervention group timeline After completing baseline data and randomisation, participants will receive access to the intervention website. Participants will be asked to complete one module per day (in the NICU or at home, at their convenience) for 7 days and will receive a daily reminder via text or email to do so. The second week of the intervention, participants will receive 3 email or text reminders directing them to practice the skills from the previous week. Group 2: Online education-only group timeline After completing baseline data and randomisation, participants will receive access to the education-only intervention website. Participants will be asked to complete one module per day (in the NICU or at home, at their convenience) for 7 days and receive a daily reminder via text or email to do so. The second week, participants will be reminded to review the content via 3 text and/or email prompts. To measure intervention adherence, in both intervention groups participants will be asked to click a button at the end of each module to show module completion, and they will also complete a one-question survey on that module’s web page which reads: “How helpful did you find this module?” Answers will range from 1 (“not helpful at all”) to 5 (“extremely helpful”). In the final module, they will be asked two additional open-ended questions about their experience. Additionally, activity log data provided by the web site platform will be analysed to assess participant usage of the intervention and overall adherence. Intervention Descriptions Group 1: ACT Plus Education intervention The online ACT plus education intervention was designed for the Aotearoa New Zealand population in consultation with Maori, NICU parents and caregivers, whanau/family, and NICU clinicians (via a previous qualitative study designed to inform this study and separate consultation sessions for intervention component development). The intervention will incorporate simple, evidence-based techniques (e.g. breathing exercises, values-based action plans, and cognitive defusion strategies) and educational information relevant to NICU parents to deliver a stress-reduction intervention tailored to the needs of NICU parents and caregivers and whanau/family. The intervention landing page (website) will provide an introduction to ACT, its benefits, and quick access to each module. The intervention has seven 10-minute modules designed to teach three core skills involved in ACT: (1) mindfulness for focusing the attention non-judgmentally to the present moment; (2) cognitive defusion activities to build acceptance and a new way of relating to negative thoughts and feelings; and (3) an exploration of a participant’s values and the development of a values-based action plan. Each module includes psychoeducation on the module’s content; a mindfulness activity or other skills-based activity; and educational information about the NICU and/or premature babies. The educational content was designed in partnership with a NICU clinician and adapted from the Integrated Family Delivered Neonatal Care app (created by Imperial College Healthcare in the UK), which received positive feedback from participants in a previous qualitative study designed to inform this study. Group 2: Education-only intervention The education-only intervention will include only the education content from the ACT plus education intervention. As noted above, this content was designed for the Aotearoa New Zealand population in consultation with Maori, NICU parents and caregivers, whanau/family, and NICU clinicians (via a previous qualitative study designed to inform this study and separate consultation sessions for intervention component development). A NICU clinician helped write and adapt relevant educational content for this intervention from the Integrated Family Delivered Neonatal Care app (created by Imperial College Healthcare in the UK). The intervention landing page (website) will provide an introduction to the study and the educational content included in the modules. Seven 10-minute modules composed of written information and photographs will cover a range of education topics aimed at the needs and interests of parents and caregivers of premature babies. These topics will include the roles of different medical providers in the NICU, common premature baby medical conditions, treatments used in the NICU, and kangaroo care. All study participants will require data or internet connectivity and a personalised link to access the websites used in this study. To ensure equity, prepaid mobile data cards will be provided to all participants, and for those without a device that can access the internet, free basic smartphones will be provided with data access. The study site (Starship Child Health NICU) offers free WiFi to all visitors.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for participants will include: (1) parents and caregivers (mothers, fathers, whanau/extended family members) who are routinely in the NICU and are 16 years or older and (2) can understand English; (3) and whose babies are born at less than 32-week gestation, (4) are less than 1 week old, and (5) have an expected admission of at least 2 weeks or more at Starship Child Health NICU.
Exclusion criteria
Exclusion criteria for participants will include: (1) severe mental health disorder (i.e. psychosis) requiring in-patient care, and participants whose babies are (2) likely to die in the first week of admission or have died before randomisation, (3) have severe congenital anomalies that require surgery or impact longer term development or health outcomes and will therefore require specialized support and/or (4) are triplets or more.
Outcome results
None listed