- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167709
CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Scania
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Lund, Scania, Sweden, 221 00
- Lund University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Allocated CHS nurses
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Cultural Competence Training Questionnaire
Time Frame: the questionnaire are given before and directly after the educational intervention
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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.
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the questionnaire are given before and directly after the educational intervention
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General Self Efficacy scale
Time Frame: the questionnaire are given before and directly after the educational intervention
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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.
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the questionnaire are given before and directly after the educational intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mothers offered to participate in screening
Time Frame: before the educational intervention are given and one year after the educational intervention are given
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number of mothers offered to participate in screening for postpartum depression
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before the educational intervention are given and one year after the educational intervention are given
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mothers participating in screening
Time Frame: before the educational intervention are given and one year after the educational intervention are given
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number of mothers participating in screening for postpartum depression
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before the educational intervention are given and one year after the educational intervention are given
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screening with help of interpreter
Time Frame: before the educational intervention are given and one year after the educational intervention are given
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number of screenings performed with help of an interpreter
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before the educational intervention are given and one year after the educational intervention are given
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mothers offered follow-up after screening
Time Frame: before the educational intervention are given and one year after the educational intervention are given
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number of mothers offered follow-up after participating in screening for postpartum depression
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before the educational intervention are given and one year after the educational intervention are given
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Inger Kristensson Hallström, professor, Lund University, Faculty of Medicine, Department of Health Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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. 2022 May 6. doi: 10.1111/scs.13086. Online ahead of print.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/1063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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