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Trial registered on ANZCTR


Registration number
ACTRN12623000641695
Ethics application status
Approved
Date submitted
24/05/2023
Date registered
14/06/2023
Date last updated
15/04/2024
Date data sharing statement initially provided
14/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A digital intervention trial targeting stress for parents and caregivers with premature babies in the neonatal intensive care unit (NICU)
Scientific title
A digital Acceptance and Commitment Therapy and education intervention targeting stress for parents and caregivers with preterm babies in the neonatal intensive care unit (NICU): a randomised controlled cluster trial
Secondary ID [1] 309648 0
None
Universal Trial Number (UTN)
U1111-1292-9848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 329983 0
Anxiety 329984 0
Depression 329985 0
Condition category
Condition code
Mental Health 326889 326889 0 0
Other mental health disorders
Mental Health 326890 326890 0 0
Anxiety
Mental Health 326891 326891 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 326078 0
Behaviour
Intervention code [2] 326079 0
Lifestyle
Comparator / control treatment
Participants in the standard care control group will be sent an introductory email and a personalized link to the existing Starship NICU parent information webpage for parent information (https://starship.org.nz/when-your-baby-is-in-nicu/). They will receive daily reminders about the content in the first week. The second week, participants will be reminded to review the content through 3 text and/or email prompts.

Regardless of group assignment, parents in this study will have access to standard care services at Starship Child Health NICU, which includes as-needed referrals (usually made by the nursing team) to a social worker and psychological support consult teams (a psychotherapist and psychiatrist).
Control group
Active

Outcomes
Primary outcome [1] 334730 0
Parental/caregiver stress in the NICU, measured by the Parental Stressor Scale: NICU (PSS:NICU) (Turner et al, 2015)
Timepoint [1] 334730 0
Baseline, 2-weeks post-randomisation, and at discharge.
Secondary outcome [1] 421900 0
Overall stress, measured by the Perceived Stress Scale (PSS) (Cohen et al., 1983)
Timepoint [1] 421900 0
Baseline, post-randomisation, discharge, and 3-months post-discharge
Secondary outcome [2] 421901 0
State (current) anxiety, measured by the 6-item Spielberger State Trait Anxiety Index (STAI-6) (Spielberger et al., 1983)
Timepoint [2] 421901 0
Baseline, post-randomisation, discharge, and 3-months post-discharge
Secondary outcome [3] 421902 0
Depression symptoms, measured by the Center for Epidemiologic Studies Depression Scale (CESD-10) (Andresen et al., 1994)
Timepoint [3] 421902 0
Baseline, post-randomisation, discharge, and 3-months post-discharge
Secondary outcome [4] 421903 0
Psychological flexibility, measured by the Acceptance and Action Questionnaire (AAQ-9) (Hayes et al., 2004)
Timepoint [4] 421903 0
Baseline, post-randomisation, discharge, and 3-months post-discharge
Secondary outcome [5] 421904 0
Intervention adherence & acceptability.
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?” 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. Adherence to the intervention protocol will be defined as participant completion of at least 5 out of 7 modules.
Timepoint [5] 421904 0
At the end of each module and at intervention completion
Secondary outcome [6] 421905 0
Infant clinical information.
A researcher will collect the following infant clinical data from the medical record at discharge to home: length of stay, breastfeeding at discharge, and the number of psychosocial referrals made for parents and caregivers.
Timepoint [6] 421905 0
Discharge

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed from participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised by computer programme and stratified by multiple birth (twins) into one of the three study arms, with the unit of randomisation as the whanau/family. Whanau/family of the same baby (or babies in the case of twins) will be randomised into the same group (cluster) to avoid sample contamination.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
We calculated the sample size with a method that takes into account the intracluster correlation coefficient, the number of participants per cluster, the expected effect, and the power of the study. We calculated to see a reduction in the individual total parental/caregiver PSS:NICU stress score from 2 to 1.8, with a SD of 0.23 at a power of 80%, alpha 0.05. This large effect size relates to between-group improvement in parental stress scores reported in a previous RCT to reduce parental stress in the NICU.

We predicted an average cluster size of 1.7 participants per family unit, which is based on our previous qualitative study with similar eligibility criteria at the same study site. We expect most family units will be composed of parent dyads (i.e. mother and father of the same baby), and therefore used an intracluster correlation (ICC) of ? = 0.5, which is the average ICC between parents of hospitalized children on emotional distress metrics reported in a previous study.

We added an additional 12% to our sample size to account for potential participant drop-out rates as reported in previous studies13 and early neonatal death.

Therefore, our total intended sample size is 102 participants in 60 family units. The sample will include at least 21 Maori participants to match the annual average NICU admission rate (21%) of this population to Starship Child Health NICU.


Statistical Analysis
The main intervention effects will be evaluated on an intention-to-treat basis, and per protocol analysis will also be conducted for all standard care group participants and all participants in the intervention groups who complete at least 5 intervention modules. Cluster correlation will also be taken into account in the analysis. All eligible participants will be analysed according to the assigned condition at randomisation, adjusting for stratification factor (multiple birth). Other baseline confounders that are closely associated with the outcomes will be adjusted in the model if there is evidence of group imbalance. For the primary outcomes, PSS:NICU score post-randomisation will be analysed using generalised linear regression with the model-adjusted scores at baseline. The between group difference will be estimated with 95% confidence interval and p-value. An overall type I error rate of 5% will be maintained controlling for multiple comparisons. Secondary outcomes will be evaluated using regression models appropriate to their distributions with similar model adjustment. Primary analyses will focus on the main effect of each intervention against its comparator, controlling for co-intervention in the same condition. Missing data will not be imputed on the study outcomes, as the key assumption of missing at random is unlikely to hold in the analysis populations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/12/2023
Actual
14/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
24
Final
Recruitment outside Australia
Country [1] 25500 0
New Zealand
State/province [1] 25500 0
Auckland

Funding & Sponsors
Funding source category [1] 313834 0
University
Name [1] 313834 0
University of Auckland
Country [1] 313834 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 315667 0
None
Name [1] 315667 0
Address [1] 315667 0
Country [1] 315667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312990 0
New Zealand Health and Disabilities Ethics Committees
Ethics committee address [1] 312990 0
Ethics committee country [1] 312990 0
New Zealand
Date submitted for ethics approval [1] 312990 0
06/06/2023
Approval date [1] 312990 0
16/08/2023
Ethics approval number [1] 312990 0
2023 EXP 17879

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

Contacts
Principal investigator
Name 126602 0
Dr Anna Serlachius
Address 126602 0
Department of Psychological Medicine
School of Medicine
University of Auckland
22-30 Park Avenue
Auckland, 1142
Country 126602 0
New Zealand
Phone 126602 0
+64 9 923 3073
Fax 126602 0
Email 126602 0
[email protected]
Contact person for public queries
Name 126603 0
Jane Alsweiler
Address 126603 0
Department of Paediatrics: Child and Youth Health, University of Auckland
PO Box 92019, Auckland Mail Centre, Auckland, 1142
Country 126603 0
New Zealand
Phone 126603 0
+64 09 379 7440
Fax 126603 0
Email 126603 0
[email protected]
Contact person for scientific queries
Name 126604 0
Jane Alsweiler
Address 126604 0
Department of Paediatrics: Child and Youth Health, University of Auckland
PO Box 92019, Auckland Mail Centre, Auckland, 1142
Country 126604 0
New Zealand
Phone 126604 0
+64 09 379 7440
Fax 126604 0
Email 126604 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
Participants have not given consent for individual participant data sharing.


What supporting documents are/will be available?

No Supporting Document Provided



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.