A Culturally Appropriate Intervention for Preventing and Reducing Postpartum Depression

NCT02862444 | Unknown DMC

• 1 other identifier: 0004-16-COM2
• Study Type: observational
• Target: 382
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postpartum depression (PPD) is a highly prevalent and serious mental health problem and is defined as the most recent episode of depression occurring between four weeks and twelve months after childbirth. PPD has negative effects, which are usually strongest during the first six months and may decrease the quality of mother-child interaction, adversely affecting the child's behavior and emotional and cognitive development, as well as the spouse marital relationship.PPD prevalence is estimated at 10 to 20%. A recent studies among Arab-Bedouin women, reported 31% - 43 of PPD. Aims: To develop and implement a culturally appropriate intervention program by using focus group (FGs) methodology Methods and Research program description: The study includes two phases. First, qualitative study will be conducted by using focus groups (FGs) method and based on the results of this phase we will develop a culturally based program. The second phase will include implementation and evaluation of the effectiveness of a culturally appropriate intervention.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS)

  Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS), which was used to identify the high-risk cases of PPD. The EPDS is a ten-item self-rating scale designed to identify PPD and it is widely used in primary care settings. Each item is scored on a three-point scale (from zero to three points), the minimum and maximum total score ranging from 0 to 30, respectively. A score of thirteen and over was found to be the optimal cut-off score for probable major depression. It is accepted to use a score of ten to twelve to indicate low to moderate PPD and a score of ≥13 to indicate probable major PPD.

  2016-2018

Study Arms (1)

intervention group

Culturally Appropriate Intervention

Other: Culturally Appropriate Intervention

Interventions

Culturally Appropriate Intervention OTHER

Women in the intervention arm will receive a culturally appropriate intervention that will be provided to them according to the five strategies of culturally appropriate interventions of Kreuter et al. (2003).

intervention group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study includes two phases. First, qualitative study will be conducted by using focus groups (FGs) method and based on the results of this phase the investigators will develop a culturally based program. The second phase will include implementation and evaluation of the effectiveness of a culturally appropriate intervention.

You may not qualify if:

• The study first phase (FGs): will include Arab Bedouin women in southern Israel, aged 18 and over who have experienced childbirth or/and who described themselves as experienced PPD symptoms in the past, could converse in Arabic, are ready to participate in group discussion and could physically attend the group's meetings.
• The study second phase (RCT):
• Arab Bedouin women in southern Israel
• weeks of pregnancy
• Without a severe psychiatric or other health condition needing intensive care.
• Women who do not speak Arabic
• Women who are not of Arab origin
• Women with a severe psychiatric or other health condition needing intensive care

Sponsors & Collaborators

• Clalit Health Services: lead
• Ben-Gurion University of the Negev: collaborator

Related Publications (1)

• Alfayumi-Zeadna S, Zeadna A, Azbarga Z, Salman L, Froimovici M, Alkatnany A, Grotto I, Daoud N. A Non-Randomized Controlled Trial for Reducing Postpartum Depression in Low-Income Minority Women at Community-Based Women's Health Clinics. Matern Child Health J. 2022 Aug;26(8):1689-1700. doi: 10.1007/s10995-022-03434-1. Epub 2022 Apr 21.

  PMID: 35445883 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 11, 2016

Record last verified: 2016-07