Authors
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Bellido-González, Mercedes -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2018
INTERVENTION: The randomisation will be carried out using the Epidat 4.1 program. The longitudinal follow‐up of the parents and babies will take place over two periods: prenatal, from week 28‐32 of pregnancy until the birth, and postnatal, from birth until age 12 months (corrected age, in the case of SGA babies who are also premature). The parents and their children will be evaluated and examined by psychologists at a consultation enabled for this purpose in the Virgen de las Nieves University Hospital (Granada, Spain). I. DURING THE PRENATAL PHASE Control Group The parents in the control group will receive the Gynaecological and Obstetric Standard Protocol, drawn up following the Guidelines on Management of the Small‐for‐Gestational‐Age Foetus published by the College of Obstetricians and Gynaecologists (2014, RCOG). Psychological Attention Group The parents in the psychological attention group will receive the same Gynaecological and Obstetric Standard Protocol, and in addition a psychological attention programme composed of various modules, supported by the APP, focused on cognitive‐behavioural therapy, relaxation techniques, mother and infant care, psychoeducation and prenatal stimulation. II. DURING THE POSTNATAL PHASE Control Group The babies in the control group will receive the Queensland Maternity and Neonatal Clinical Guidelines Programme (2016), performed by paediatricians. Additionally, psychologists will carry out a neonatal assessment after birth, followed by several developmental assessments during the babies’ first year of life. Psychological Attention Group The babies in the psychological attention group will receive the same paediatric and psychological protocol as those in the control group. In addition, their parents will be given the psychological postnatal programme, supported by the APP, composed of four modules: cognitive‐behavioural therapy, relaxation techniques, psychoeducation about family functioning and care for SGA babies, and emotional intellig CONDITION: Risk pregnancy, small‐for‐gestational‐age fetuses ; Pregnancy and Childbirth INCLUSION CRITERIA: Parents whose foetuses are identified as Small‐for‐Gestational‐Age (birth weight below the 10th percentile, taking into account the gestational age) PRIMARY OUTCOME: Prenatal:; 1. Adherence to the APP‐PRE: the participants’ adherence to the psychological attention programme sessions will be measured by the APP, which registers daily session activity and records the answers given to questions asked at the end of each session; 2. General emotional state (depression, stress, anxiety and resilience) measured using the Spanish versions of standardised questionnaires [Edinburgh Depression Scale (EPDS, García‐Esteve L, Ascaso C, Ojuel J, Navarro P. 2002), Perceived Stress Scale (PSS‐14, Remor, EP., 2006), SCL‐90 Anxiety Subscale (SCL‐90, González de Ribera, 2002) and Connor Davidson–Resilience Scale for Chronic Stress (CD‐RISC 10, Crespo, M., Fernández‐Lansac, V., & Soberón, C. 2014).)], to be completed by all participants at various moments in this phase of the study: ; PSS‐14: WEEK 20, WEEK 28‐32, WEEK 41 (AT BIRTH); EPDS‐10: WEEK 20, WEEK 28‐32, WEEK 41 (AT BIRTH); Anxiety subscale SCL‐90: WEEK 20, WEEK 28‐32, WEEK 41 (AT BIRTH); CD‐RISC‐10: WEEK 20, WEEK 28‐32, WEEK 41 (AT BIRTH); 3. Physiological signs of stress, monitored by an Empatica Embrace® bracelet. This device contains a sensor of psychophysiological responses such as heart rate and body temperature. The bracelet will be used by both parents during the ultrasound examination. In the experimental group, it will be worn during ultrasound at two moments: before and after the psychological attention programme (one month’s duration). In the control group it will be worn during ultrasound at two moments, with a separation of one month; 4. Stimulation skills in the experimental group will be measured by an instrument developed specifically for this study, and performed at birth in an observational session with the parents and their babies; 5. The neonatal development of the babies will be measured according to the Neonatal Behaviour Assessment Scale, NBAS (Brazelton, 1997) at birth; ; Postnatal:; 1. Adherence by the participants will be measured by the APP, which records daily session activity and by reference to the answers given to questions asked at the end of each session; 2. General emotional state and parent‐baby attachment during the first year of life will be measured using the questionnaires above and, for attachment, the Postpartum Bonding Questionnaire (PBQ‐25, García‐Esteve et al., 2015) to be completed at week 41, age 3 months, and age 12 months; 3. Competence in parenting skills will be measured, using a specially‐developed instrument at birth in an observational session with the parents and their babies; 4. The cognitive, language and behavioural development of the babies in the experimental group will be measured by the Bayley Scales of Infant Development III, (Bayley, 2006; Spanish adaptation by CDIAP Parc Taulí, Universidad de Murcia and department of I+D Pearson Clinical & Talent Assessment, 2015) at 3, 6 and 12 months of age SECONDARY OUTCOME: Prenatal:; 1. Depression requiring mental health care, measured using the instruments commented above; 2. Viability measured by recording the parents’ daily use of the APP and by the answers given to questions shown at the end of each session. In addition, a specific questionnaire about the APP has been designed, regarding its usability, manageability and clarity, among other questions; 3. Feedback on usability measured by recording the parents’ daily use of the APP and by the answers given to questions (developed specifically for this study) about its usability, manageability and clarity, among other aspects; ; Postnatal:; 1. Depression requiring mental health care, measured using the instruments commented above; 2. Viability measured by recording the parents’ daily use of the APP and by the answers given to questions shown at the end of each session. In addition, a specific questionnaire about the APP has been designed, regarding its usability, manageability and clarity, among other questions; 3. Feedback on usability measured by recording the parents’ daily use of the APP and by the answers given to questions (developed specifically for this study) about its usability, manageability and clarity, among other aspects; 4. Profitability assessed from the records contained in the hospital database on the number of premature births, caesarean sections and requests for mental health care for parents and for early care for babies, evaluated at the end of the postnatal program
Epistemonikos ID: bb5a4e71180f9c041ab892f64bac5f88c7a7a767
First added on: Aug 24, 2024