NCT04167709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

November 4, 2019

Last Update Submit

September 3, 2021

Conditions

Keywords

postpartum depressionimmigrant womenChild Health ServicesnurseEdinburgh Postnatal Depression Scale

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • mothers offered to participate in screening

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

  • mothers participating in screening

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

  • screening with help of interpreter

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

  • mothers offered follow-up after screening

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

Study Arms (1)

Allocated CHS nurses

EXPERIMENTAL

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.

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

Interventions

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

Allocated CHS nurses

Eligibility Criteria

Age25 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, Skåne County, 221 00, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 3651732BACKGROUND
  • 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. 2023 Mar;37(1):173-184. doi: 10.1111/scs.13086. Epub 2022 May 6.

Related Links

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Educational StatusClinical Competence

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Inger Kristensson Hallström, professor

    Lund University, Faculty of Medicine, Department of Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The study has a pre-post experimental design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 19, 2019

Study Start

June 9, 2019

Primary Completion

May 13, 2020

Study Completion

March 31, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

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

Locations