A Digital Acceptance and Commitment Therapy and Education Intervention Targeting Stress of Parents and Caregivers with Preterm Babies in the Neonatal Intensive Care Unit: A Randomised Controlled Cluster Trial Protocol

Simple item page
aut.relation.articlenumber107519
aut.relation.journalContemporary Clinical Trials
aut.relation.startpage107519
aut.relation.volume140
dc.contributor.authorGinsberg, KH
dc.contributor.authorAlsweiler, J
dc.contributor.authorRogers, J
dc.contributor.authorCavadino, A
dc.contributor.authorDouglas, M
dc.contributor.authorSerlachius, A
dc.date.accessioned2024-11-06T00:12:37Z
dc.date.available2024-11-06T00:12:37Z
dc.date.issued2024-03-27
dc.description.abstractBackground: Parents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems. Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education. Therefore, the primary aim of this study is to determine if a digital intervention that uses a brief form of ACT plus parent education will reduce the stress of primary caregivers with preterm babies in the NICU more than a digital education-only intervention or standard care control group. Methods: In a randomised controlled cluster trial design, participants will be randomly assigned to one of three groups: ACT plus education; education-only; or standard care control. The primary outcome will be parental/caregiver stress levels, measured on the Parental Stress Scale: Neonatal Intensive Care Unit. Secondary outcomes include overall stress, anxiety, and depression. Outcome measures will be evaluated at baseline, two weeks after enrolment, discharge to home, and 3-months post-discharge. Conclusion: This study will explore the efficacy of a digital ACT plus education intervention on parental stress levels. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test ACT as a stand-alone intervention with this population. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 June 2023 (ACTRN12623000641695p).
dc.identifier.citationContemporary Clinical Trials, ISSN: 1551-7144 (Print); 1559-2030 (Online), Elsevier BV, 140, 107519-. doi: 10.1016/j.cct.2024.107519
dc.identifier.doi10.1016/j.cct.2024.107519
dc.identifier.issn1551-7144
dc.identifier.issn1559-2030
dc.identifier.urihttp://hdl.handle.net/10292/18233
dc.languageeng
dc.publisherElsevier BV
dc.relation.urihttps://www.sciencedirect.com/science/article/pii/S1551714424001022
dc.rights© 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
dc.rights.accessrightsOpenAccess
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectAcceptance and Commitment therapy
dc.subjectAnxiety
dc.subjectDepression
dc.subjectDigital mental health interventions
dc.subjectNICU parents
dc.subjectPreterm babies
dc.subjectRCT protocol
dc.subjectStress
dc.subject3213 Paediatrics
dc.subject32 Biomedical and Clinical Sciences
dc.subjectPediatric
dc.subjectClinical Research
dc.subjectPerinatal Period - Conditions Originating in Perinatal Period
dc.subjectMental Illness
dc.subjectBehavioral and Social Science
dc.subjectPreterm, Low Birth Weight and Health of the Newborn
dc.subjectComparative Effectiveness Research
dc.subjectDepression
dc.subjectMind and Body
dc.subjectHealth Disparities
dc.subjectMinority Health
dc.subjectMental Health
dc.subjectClinical Trials and Supportive Activities
dc.subjectBrain Disorders
dc.subject6.6 Psychological and behavioural
dc.subjectMental health
dc.subject4 Quality Education
dc.subject3 Good Health and Well Being
dc.subject11 Medical and Health Sciences
dc.subjectGeneral Clinical Medicine
dc.subjectPublic Health
dc.subject32 Biomedical and clinical sciences
dc.subject42 Health sciences
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshInfant, Newborn
dc.subject.meshMale
dc.subject.meshAcceptance and Commitment Therapy
dc.subject.meshAnxiety
dc.subject.meshCaregivers
dc.subject.meshDepression
dc.subject.meshInfant, Premature
dc.subject.meshIntensive Care Units, Neonatal
dc.subject.meshParents
dc.subject.meshStress, Psychological
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshHumans
dc.subject.meshDepression
dc.subject.meshStress, Psychological
dc.subject.meshAnxiety
dc.subject.meshParents
dc.subject.meshInfant, Newborn
dc.subject.meshInfant, Premature
dc.subject.meshCaregivers
dc.subject.meshIntensive Care Units, Neonatal
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshAcceptance and Commitment Therapy
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshInfant, Newborn
dc.subject.meshMale
dc.subject.meshAcceptance and Commitment Therapy
dc.subject.meshAnxiety
dc.subject.meshCaregivers
dc.subject.meshDepression
dc.subject.meshInfant, Premature
dc.subject.meshIntensive Care Units, Neonatal
dc.subject.meshParents
dc.subject.meshStress, Psychological
dc.subject.meshRandomized Controlled Trials as Topic
dc.titleA Digital Acceptance and Commitment Therapy and Education Intervention Targeting Stress of Parents and Caregivers with Preterm Babies in the Neonatal Intensive Care Unit: A Randomised Controlled Cluster Trial Protocol
dc.typeJournal Article
pubs.elements-id544411
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Ginsberg et al._2024_A digital Acceptance and Commitment Therapy.pdf
Size:
1.25 MB
Format:
Adobe Portable Document Format
Description:
Journal article
Download
Collections
School of Clinical Sciences - Te Kura Mātai Haumanu