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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04167709
Other study ID # 2018/1063
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 9, 2019
Est. completion date March 31, 2021

Study information

Verified date September 2021
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is to develop, test and evaluate an educational intervention with the purpose to strengthen Child Health Services (CHS) Nurses clinical competence in detecting signs of postpartum depression in non-native-speaking immigrant mothers. The pilot study has a pre-post experimental design. Data are collected before and after the intervention. The differences in the values of the collected data are used to estimate the effect of the intervention.


Description:

To be eligible for the study the CHS nurse must perform screening of immigrant mothers for postpartum depression with help of an interpreter according to the Edinburgh Postnatal Depression Scale (EPDS) method more than three times a year. The EPDS is a likert form scale with ten statements and is used in combination with a Clinical interview. Approximately 40-45 CHS nurses will be enrolled in the pilot study. The number of nurses are calculated in comparison to two other published studies within the same context. The instruments Clinical Cultural Competence Training Questionnaire (CCCTQ) and General Self-Efficacy scale (GSE) will be used as primary outcomes measures. Data are collected before the first education day and after the second education day. Secondary outcomes are also collected in connection to the educational intervention and consists of reported yearly statistics; how many mothers were are offered screening, participated in screening, number of screenings preformed with help og an interpreter and number of mothers offered follow-up after participating in screening.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2021
Est. primary completion date May 13, 2020
Accepts healthy volunteers No
Gender All
Age group 25 Years to 67 Years
Eligibility Inclusion Criteria: - Nurse specialized in Primary Healthcare Nursing or Pediatric Nursing - Employed in the Child Health Services in the County Scania in Sweden - Performing at minimum three screenings per year for postpartum depression, according to the EPDS-method, with help of an interpreter Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education in clinical competence in detecting signs of postpartum depression in immigrant mothers
Groupbased educational intervention aimed at nurses in the Child Health Services in strengthening clinical competence in detecting signs of postpartum depression in non-native-speaking immigrant mothers

Locations

Country Name City State
Sweden Lund University Lund Scania

Sponsors (3)

Lead Sponsor Collaborator
Lund University Föreningen Mjölkdroppen Helsingborg, Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. — View Citation

Löve J, Moore CD, Hensing G. Validation of the Swedish translation of the General Self-Efficacy scale. Qual Life Res. 2012 Sep;21(7):1249-53. doi: 10.1007/s11136-011-0030-5. Epub 2011 Oct 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Cultural Competence Training Questionnaire measures change in the participants experienced cultural competence. Consist of 8 items. Responses are made on a 4-pointscale.The mean score is calculated by adding up the sum of all answers (range 8-32) and dividing it by 8. The higher score the better outcome. the questionnaire are given before and directly after the educational intervention
Primary General Self Efficacy scale measures change in the participants confidence in their own ability. Consist of 10 items. Responses are made on a 4-pointscale.The mean score is calculated by adding up the sum of all answers (range 10-40) and dividing it by 10. The higher score the better outcome. the questionnaire are given before and directly after the educational intervention
Secondary mothers offered to participate in screening number of mothers offered to participate in screening for postpartum depression before the educational intervention are given and one year after the educational intervention are given
Secondary mothers participating in screening number of mothers participating in screening for postpartum depression before the educational intervention are given and one year after the educational intervention are given
Secondary screening with help of interpreter number of screenings performed with help of an interpreter before the educational intervention are given and one year after the educational intervention are given
Secondary mothers offered follow-up after screening number of mothers offered follow-up after participating in screening for postpartum depression before the educational intervention are given and one year after the educational intervention are given
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