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CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'

Primary Purpose

Depression, Postpartum

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Education in clinical competence in detecting signs of postpartum depression in immigrant mothers

About this trial

This is an interventional health services research trial for Depression, Postpartum focused on measuring postpartum depression, immigrant women, Child Health Services, nurse, Edinburgh Postnatal Depression Scale

Eligibility Criteria

25 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Lund University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allocated CHS nurses

Arm Description

Primary and secondary baseline data are collected from the allocated CHS nurses before the study starts. The CHS nurses are then given the educational intervention and afterwards primary and secondary outcomes are collected again.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

mothers offered to participate in screening

number of mothers offered to participate in screening for postpartum depression

mothers participating in screening

number of mothers participating in screening for postpartum depression

screening with help of interpreter

number of screenings performed with help of an interpreter

mothers offered follow-up after screening

number of mothers offered follow-up after participating in screening for postpartum depression

Full Information

NCT ID

NCT04167709

First Posted

November 4, 2019

Last Updated

September 3, 2021

Sponsor

Lund University

Collaborators

Region Skane, Föreningen Mjölkdroppen Helsingborg

1. Study Identification

Unique Protocol Identification Number

NCT04167709

Brief Title

CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'

Official Title

Child Health Services Nurses Clinical Competence in Detecting Signs of Post Partum Depression in Non-Native-Speaking Immigrant Mothers' -Development, Testing and Evaluation of an Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

June 9, 2019 (Actual)

Primary Completion Date

May 13, 2020 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lund University

Collaborators

Region Skane, Föreningen Mjölkdroppen Helsingborg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Postpartum

Keywords

postpartum depression, immigrant women, Child Health Services, nurse, Edinburgh Postnatal Depression Scale

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The study has a pre-post experimental design.

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allocated CHS nurses

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Education in clinical competence in detecting signs of postpartum depression in immigrant mothers

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical Cultural Competence Training Questionnaire

Description

Time Frame

the questionnaire are given before and directly after the educational intervention

Title

General Self Efficacy scale

Description

Time Frame

the questionnaire are given before and directly after the educational intervention

Secondary Outcome Measure Information:

Title

mothers offered to participate in screening

Description

number of mothers offered to participate in screening for postpartum depression

Time Frame

before the educational intervention are given and one year after the educational intervention are given

Title

mothers participating in screening

Description

number of mothers participating in screening for postpartum depression

Time Frame

before the educational intervention are given and one year after the educational intervention are given

Title

screening with help of interpreter

Description

number of screenings performed with help of an interpreter

Time Frame

before the educational intervention are given and one year after the educational intervention are given

Title

mothers offered follow-up after screening

Description

number of mothers offered follow-up after participating in screening for postpartum depression

Time Frame

before the educational intervention are given and one year after the educational intervention are given

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

67 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Inger Kristensson Hallström, professor

Organizational Affiliation

Lund University, Faculty of Medicine, Department of Health Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Lund University

City

Lund

State/Province

Scania

ZIP/Postal Code

221 00

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Since this is a small pilot study a study protocol will not be published.

Citations:

PubMed Identifier

3651732

Citation

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. doi: 10.1192/bjp.150.6.782.

Results Reference

background

PubMed Identifier

21984467

Citation

Love 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.

Results Reference

result

PubMed Identifier

35524434

Citation

Skoog M, Rubertsson C, Kristensson Hallstrom I. Feasibility of an evidence-based educational intervention in screening immigrant mothers for postpartum depression: A pretest-posttest experimental design. Scand J Caring Sci. 2023 Mar;37(1):173-184. doi: 10.1111/scs.13086. Epub 2022 May 6.

Results Reference

derived

Links:

URL

https://www.mem-tp.org/pluginfile.php/1161/mod_resource/content/1/2013%2062%2009_MEM_TP%20Interim%20Report_March_2015.pdf

Description

European Community contract no. 2013 62 09

URL

http://www.mrc.ac.uk/index.cfm/searchresults/?keywords=complex+interventions&display=search&newSearch=true&noCache=1

Description

Medical Research Councils framework for complex interventions

Learn more about this trial

CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'

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