Depression, Postpartum Clinical Trial
Official title:
The Northern Babies Longitudinal Study: Predicting Postpartum Depression and Improving Parent-infant Interaction With The Newborn Behavioral Observation
Postpartum depression (PPD) is a prevalent disorder. Studying the factors related to PPD will help to identify families at risk and provide preventive interventions. This can in turn improve the developmental trajectories for the children. Several previous studies have investigated risk factors for PPD. However, few studies have focused on cognitive vulnerability factors. The first aim of the present study is to explore a range of protective and risk factors, including cognitive factors, for PPD, parent-infant interactions and child development. The second aim of the study is to evaluate the effectiveness of The Newborn Behavioral Observation (NBO) as a universal preventive intervention delivered in routine practice. The NBO is a brief relationship-enhancing intervention that may reduce depressive symptomatology in mothers.
Aims
The present study has three broad aims:
1. Examine key pre- and postnatal predictors related to parental functioning: a) parental
depression, anxiety, and stress, b) parental reflective functioning in relation to the
infant, and c) parent-infant attachment style.
2. Examine key pre- and postnatal predictors related to interaction and developmental
problems in the child: a) difficulties in parent-infant interaction in the first 4
months post-delivery, and b) infant's cognitive, communicative and motor development,
signs of sustained withdrawal behaviour, and heart-rate variability at 6 months
post-delivery.
3. Evaluate the effectiveness of the NBO as a universal preventive intervention delivered
in routine practice as compared to standard care, on:
- Parental outcomes (depressive symptoms, parenting stress, reflective functioning,
attachment to the infant),
- Relational outcomes (emotional availability in parent-child interaction), and
- Infant outcomes (cognitive, communicative and motor development at 6 months
post-delivery, heart-rate variability).
Predictor variables include some well-known vulnerability factors for developing PPD (e.g.,
depression symptoms in pregnancy, adult attachment style, relationship satisfaction and life
stress), but the main focus in the observational part of the research project is on cognitive
vulnerability factors such as early maladaptive schemas, repetitive negative thinking,
rumination, implicit attitudes and cognitive processing of emotionally valenced infant facial
information.
Study design This is a longitudinal observational study with an intervention. The
observational part of the study will use a prospective cohort design. The effect of the
intervention will be evaluated using a non-randomized cluster controlled design, since
neither cluster nor individual randomization is feasible in this routine practice setting. An
intervention group receiving NBO (families belonging to two well-baby clinics in Tromsø
municipality) will be compared with a control group (families at the remaining four well-baby
clinics in Tromsø) receiving care as usual.
Recruitment All pregnant women and expecting fathers who speak Norwegian are eligible for
inclusion in the study. Between autumn 2015 and autumn 2018 approximately 200 families will
be recruited by midwifes and by general practitioners (GPs) in the municipality of Tromsø,
which is the 9th largest municipality in Norway (~73000 inhabitants; 78). There are
approximately 1000 births a year in Tromsø municipality. Based on the experiences from a
comparable study, "Little in Norway" (79), the recruitment of 200 families within the project
period is considered feasible.
The participants will be recruited in (approximately) week 16 of gestation. At recruitment,
women will be given written information about the study and a flyer with an inquiry to be
contacted by the research team. If the child`s father is not present, the mother is
encouraged to inform him about the study. The health worker informs the research team who
contacts the women to plan a meeting with them and their partners, preferable between week 16
and 22 of gestation. In this meeting, the prospective parents are given detailed information
about the study and are invited to sign an informed consent to participate. In addition, at 4
months post-delivery the parents will be asked to sign an informed consent to obtain birth
related information from the birth record.
Power calculations/statistical analysis The sample size is calculated on the basis of
differences between intervention group and standard care group on the Edinburgh Postnatal
Depression Scale (EPDS) maternal score, the Parenting Stress Index (PSI-PD), the Parental
Reflective Functioning Scale (PRFQ) and the Maternal Postnatal Attachment Scale (MPAS) 6
weeks post-delivery. Based on the pilotstudy by Nugent et al. (69) and some regression to the
mean, we expect a small to medium effect size (f2 = .07). A MANOVA with the four
aforementioned outcome variables can detect a difference between the groups with a power of
.80 given a group sizes of N = 176. With an estimated dropout of 10 %, a group size of 200
will be recruited. The estimation is based on an α-level of .05.
Procedure For the observational part of the study, assessments will be performed at six time
points (see Table 1): During gestational week 16 - 22 (Step 1), 24 - 30 (Step 2) and 31 (Step
3), and at 6 weeks (Step 4), 4 months (Step 5) and 6 months (Step 6) post-delivery. For the
intervention study, pre-intervention measures will be collected at Step 3, post-intervention
measures at Step 4 and follow-up measures at Step 5 and 6. Since the families will receive
the first NBO already two-days post-delivery, no pre-test assessment can be obtained for the
interaction and infant measures. Hence, analyses of intervention effects will be based on
differences between groups at 4 and 6 months post-delivery controlling for relevant
covariates. The data is collected using online questionnaires, computerized cognitive tests,
video-filmed observations of mother-infant interactions, and a standardised test of the
child's cognitive, communicative and motor development (Bayley Scales of Infant and Toddler
Development; 80).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04012580 -
Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression
|
N/A | |
Recruiting |
NCT05813782 -
The Effect of Baby Massage on Postpartum Depression and Maternal Attachment
|
N/A | |
Recruiting |
NCT05907213 -
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery
|
Phase 1 | |
Completed |
NCT00602732 -
Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
|
Phase 1 | |
Completed |
NCT00043602 -
Clinician Managed Interpersonal Psychotherapy
|
Phase 0 | |
Completed |
NCT00053651 -
Prevention of Postpartum Depression in Low-Income Women
|
Phase 1 | |
Completed |
NCT04169334 -
Look - Your Baby is Talking to You.
|
N/A | |
Completed |
NCT03573713 -
Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
|
N/A | |
Completed |
NCT04043533 -
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women
|
N/A | |
Completed |
NCT06070168 -
Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
|
N/A | |
Recruiting |
NCT05050266 -
Enhancing Mental and Physical Health of Women Veterans
|
N/A | |
Completed |
NCT02505984 -
Preventing Postpartum Depression With Intranasal Oxytocin
|
Phase 2 | |
Recruiting |
NCT00251342 -
Outcome of Postnatal Depression Screening Using Edinburgh Postnatal Depression Scale
|
Phase 2/Phase 3 | |
Completed |
NCT02526407 -
The Impact of Creative Interventions on Symptoms of Postnatal Depression
|
N/A | |
Completed |
NCT02526433 -
The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
|
N/A | |
Completed |
NCT03574766 -
Meditation for NICU Moms
|
N/A | |
Completed |
NCT03646539 -
RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood
|
N/A | |
Active, not recruiting |
NCT05110456 -
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
|
N/A | |
Recruiting |
NCT04154423 -
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
|
N/A | |
Not yet recruiting |
NCT04093791 -
MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention
|
N/A |