Risk pregnancy, small-for-gestational-age fetuses Pregnancy and Childbirth
Conditions
Interventions
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
Sponsors
Fundación Pública Andaluza para la investigación Biosanitaria Andalucía Oriental (FIBAO)
Consejería de Salud, Junta de Andalucía
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Parents whose foetuses are identified as Small-for-Gestational-Age (birth weight below the 10th percentile, taking into account the gestational age)
Exclusion criteria
Exclusion criteria: 1. Parents who are drug users 2. Mothers who present high depression scores (score >15 on the Edinburgh Scale) or other psychiatric disorders, and/or are receiving psychotherapy 3. Infants whose parents or guardians do not speak Spanish as a mother tongue 4. Parents who do not give their signed informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 activ | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Outcome results
None listed