Implementation of a Psychoeducational Intervention in New Mothers

Browse trials for

• Depression, Postpartum 528
• Depression 8,057

Keywords

• Postpartum Period
• Prevention
• Preventive Health Care
• Psychoeducation
• Primiparity
• Female

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's planned enrollment of 400 is above the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Lead sponsor

This is the only study on the registry with Alba Roca as lead sponsor.

Study arms

• No intervention
  Usual Care

  Participants will received the postpartum usual care at the Sexual and Reproductive Health Service (ASSIR).

• Experimental
  WWWT psychoeducative intervention

  Participants will received the postpartum routine usual care plus two psychoeducative intervention WWWT sessions at the Sexual and Reproductive Health Service (ASSIR).

  Behavioral: WWWT psychoeducative intervention

Interventions

• BehavioralWWWT psychoeducative intervention

  "What Were We Thinking" (WWWT) is a highly structured, interactive, gender-informed, couples-based, psycho-educational program for parents and a first newborn to promote confident parental caretaking, optimize functioning in the intimate partner relationship and improve infant care manageability. The adaptation of the WWWT programme (Catalan and Spanish version) comprises 2 sessions, each lasting 2 hours, that will be designed for groups of 5-7 families - within the first 6 weeks postpartum -, each consisting of mother, partner (or other caregiver) and their infant(s).

Primary outcomes

1. Mental Disorders

   The Mini-International Neuropsychiatric Interview (MINI) is a brief structured interview designed for the detection and diagnostic guidance of major Axis I psychiatric disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) and the International Classification of Diseases, 10th Edition (ICD-10). It has an administration time of approximately 15 minutes and is divided into 16 modules, identified by letters, each corresponding to a diagnostic category.

   Time frame: 3 and 6 months postpartum (follow-up)

2. Depressive symptoms

   The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire that is used as a screening instrument and for research purposes. Item scores are summed up to a total score (from 0 to 30 points), with higher scores indicating a higher depressive symptom burden. At a cutoff value of 11 (EPDS ≥ 11), the sensitivity of detecting a clinically significant depression is 0.79, the specificity is 0.95, and the positive predictive value is 0.63. The scale has a good internal consistency (Cronbach's α = 0.81).

   Time frame: Baseline, 3 and 6 months follow-up

3. Depressive symptoms

   The Beck Depression Inventory (BDI-II) is a 21-item self-report instrument designed to assess the severity of depressive symptomatology. In each item, the person evaluated must select the phrase that best describes their condition over the past two weeks from a list of four options, with seven alternatives in items 16 and 18. Each item is scored from 0 to 3 points, with the total score ranging from 0 to 63, with higher scores indicating a higher depressive symptom burden.

   Time frame: Baseline, 3 and 6 months follow-up

4. Anxiety symptoms

   The Generalised Anxiety Disorder Screener (GAD-7) is a 7-item self-report scale used as a screening instrument measuring symptoms of generalized anxiety disorder that has been recommended as brief screening measure for perinatal anxiety. Item scores are summed up to a total score (from 0 to 21 points), with higher scores indicating a higher anxiety symptom burden. There are no cut-off points established for the Spanish version. In the original version, the authors propose a cut-off point of greater than or equal to 10. For the Spanish version, a Cronbach's alpha coefficient of 0.93 was obtained. Considering the 10-point cutoff, sensitivity values of 86.8% and specificity of 93.4% were found.

   Time frame: Baseline, 3 and 6 months follow-up

Secondary outcomes

1. Maternal postpartum bonding

   The Postpartum Bonding Questionnaire (PBQ) is a 25-item self-report questionnaire used to evaluate the alterations of the maternal-filial bond in the postpartum period. It includes 4 subscales, with a total of 25 items, which are rated by the mother on a Likert-type scale from 0 to 5. The subscales are general factor, rejection and pathological anger, infant-centered anxiety, and incipient maltreatment scale. The Spanish adaptation and validation has an adequate psychometrics property for use with clinical and general population of Spanish puerperal women. The PBQ could be summarized in a general factor and that the use of the total score of the scale would already be useful to detect alterations in the mother-infant bond (Cronbach's alpha reliability value of 0.90). A total score of 26 or more would indicate some type of attachment disorder, and a score of 40 or more would indicate the presence of maternal rejection or a severe attachment disorder.

   Time frame: Baseline, 3 and 6 months follow-up

2. Parenting self-regulation

   The Me as a Parent scale (MaaPs) is a 16-item self-report scale used to measure the parents' perceptions of their parenting role. The scale has four theoretical sub-dimensions (Parenting Self-Efficacy; Personal Agency; Self-Management; and Self-Sufficiency), each containing four items scored on a 5-point agreement scale, with a total scale score range of 16-80. Higher scores indicate a higher parent's self-perceived competence and efficacy.

   Time frame: Baseline, 3 and 6 months follow-up

3. Marital Adjustment

   The Escala de Ajuste Diádico (EAD-13) is a 13-item self-report short version of the Dyadic Adjustment Scale (DAS) used to assess the degree of harmony or adjustment between the members of the couple's relationship through 3 dimensions: consensus (capacity, resources and skills to reach agreements or find joint solutions to problems), satisfaction (level of well-being, happiness and commitment in the couple) and cohesion (degree of involvement of one member of the couple with the other). Item scores are summed up to a total score (from 12 to 75 points), with higher scores indicating increased marital adjustment. The scale has shown adequate psychometric properties to be applied in the Spanish context, finding a Cronbach's alpha reliability value of 0.81.

   Time frame: Baseline, 3 and 6 months follow-up

4. Satisfaction survey

   Satisfaction survey is made up of Likert-type questions from 0 to 5 points (1 = completely disagree, 5 = completely agree) and open questions to measure participants' satisfaction with the WWWT psychoeducational intervention in terms of accessibility, comprehensibility, acceptability and usefulness, and identify needs or possible difficulties in its implementation.

   Time frame: Intervention group participants immediately after completing the WWWT psychoeducative group.

Other outcomes

1. Partner Violence

   The Woman Abuse Screening Tool (WAST) is 8-item self-report screening instrument for intimate partner physical, emotional and/or sexual violence. The items are answered on a scale of intensity or frequency of 3 degrees. The maximum score range of the scale ranges from 8 to 24, which is obtained from the sum of the responses of the 8 items of the scale. Higher scores indicate a higher risk of partner abuse. The scale It was translated and validated in Spanish population and finding good internal consistency (Cronbach's α = 0.95).

   Time frame: Baseline, 3 and 6 months follow-up

2. Alcohol use

   The Alcohol Use Disorders Identification Test (AUDIT-C) is a shortened version of the AUDIT, comprising the initial three items. It is designed to facilitate the expedient identification of individuals engaging in hazardous alcohol consumption. Total scores range from 0 to 12, with elevated scores indicating heightened risk-taking drinking behaviors. The sensitivity of the AUDIT-C has been demonstrated to range from 54 to 98%, while its specificity has been shown to range from 57 to 93%, depending on the definition of heavy drinking employed

   Time frame: Baseline, 3 and 6 months follow-up

3. Childhood trauma

   The Early Trauma Inventory Self Report Short-Form (ETISR-SF) is a 27-item self-report inventory that retrospectively assesses the presence of traumatic events experienced before and after the age of 18. It contains dichotomous items (yes or not) that assess general trauma, emotional, physical, or sexual abuse. The ETI-SF internal consistency ranged between 0.42 and 0.72, and test-retest reliability ranged from 0.84 to 0.96.

   Time frame: Baseline

4. Vulnerable Personality Style

   The Vulnerable Personality Style Questionnaire (VPSQ) is a 9-item self-report scale used to assess personality traits which increase the risk of postpartum depression (coping, nervy, timidity, sensitivity, worrier, organised, obsessive, expressive and volatility). It is rated on a 5-point Likert scale (1 = "not at all" to 5 = "very much so"). Total scores range from 9 to 45, and higher scores indicate increased vulnerability.

   Time frame: Baseline

5. Perceived Social Support

   The Multidimensional Perceived Social Support Scale (MSPPSS) is a 12-item measure of perceived adequacy of social support from three sources: family, friends and significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).

   Time frame: Baseline, 3 and 6 months follow-up

6. Sociodemographic variables

   Age, country of birth, current marital status, occupation prior to having the infant, highest level of education completed, employment, will be collected by an ad hoc questionnaire.

   Time frame: Baseline

7. Psychiatric history, clinical and health variables

   Self-rated general health, maternal rating of infant general health, history of diagnosed mental health problems (included substance use) and history of physical and sexual abuse will be collected by an Ad hoc questionnaire.

   Time frame: Baseline

8. Obstetrical and neonatal outcomes

   Obstetric history (previous pregnancies and abortions), type of conception (spontaneous or using Assisted Reproductive Technology), unplanned pregnancy, mode of birth, singleton infant or multiples, sex of infant, birth weight (grams), week of pregnancy when delivery took place, overall birth experience, and method of feeding the baby (breastfeeding, mixed feeding, bottle feeding) will be assessed by an Ad hoc questionnaire.

   Time frame: Baseline

9. Baby's temperament

   The Baby Temperament Scale is a 10-item scale that allows obtaining an individualized profile of 9 basic temperamental traits, and a classification between three pure categories: slow child, difficult child and active child. Each dimension allows three response options: two opposite and one intermediate. It is not an instrument with psychometric validation.

   Time frame: Baseline, 3 and 6 months follow-up

Individual participant data

Plan to share: No