Depression, PostpartumNCT04167709
CHS Nurses Clinical Competence in Detecting Signs of PPD in Non-Native Speaking Immigrant Mothers'
A study testing Education in clinical competence in detecting signs of postpartum depression in immigrant mothers in people with Depression, Postpartum, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 25 to 67 years
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Education in clinical competence in detecting signs of postpartum depression in immigrant mothers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 9 Jun 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Depression, Postpartum
- Being tested
- Education in clinical competence in detecting signs of postpartum depression in immigrant mothers
- Keywords
- postpartum depression, immigrant women, Child Health Services, nurse, Edinburgh Postnatal Depression Scale
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in clinical competence in detecting signs of postpartum depression in immigrant mothersOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education in clinical competence in detecting signs of postpartum depression in immigrant mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: the questionnaire are given before and directly after the educational intervention
Secondary outcomes (4)
mothers offered to participate in screening
number of mothers offered to participate in screening for postpartum depression
Measured: before the educational intervention are given and one year after the educational intervention are given
mothers participating in screening
number of mothers participating in screening for postpartum depression
Measured: before the educational intervention are given and one year after the educational intervention are given
screening with help of interpreter
number of screenings performed with help of an interpreter
Measured: before the educational intervention are given and one year after the educational intervention are given
mothers offered follow-up after screening
number of mothers offered follow-up after participating in screening for postpartum depression
Measured: before the educational intervention are given and one year after the educational intervention are given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start9 Jun 2019
- Primary completion13 May 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study has a pre-post experimental design.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Föreningen Mjölkdroppen Helsingborg
- Responsible party
- Sponsor
- Investigators
- Inger Kristensson Hallström, professor, Study chair, Lund University, Faculty of Medicine, Department of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167709
- Sponsor's protocol ID
- 2018/1063
- Status last verified
- Sep 2021
- First submitted
- 4 Nov 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this is a small pilot study a study protocol will not be published.
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.
PubMed 3651732Love 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.
PubMed 21984467Skoog 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.
PubMed 35524434
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04167709
- Acronym / sponsor ID
- 2018/1063
- Conditions
- Depression, Postpartum
- Keywords
- postpartum depression, immigrant women, Child Health Services, nurse, Edinburgh Postnatal Depression Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane, Föreningen Mjölkdroppen Helsingborg
- Study start
- 9 Jun 2019 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study has a pre-post experimental design.
| Arm | Type | Receives |
|---|---|---|
| Allocated CHS nurses | Experimental | Other: Education in clinical competence in detecting signs of postpartum depression in immigrant mothersPrimary 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. |
Who may qualify
- Ages
- 25 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education in clinical competence in detecting signs of postpartum depression in immigrant mothersGroupbased 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 | Other | Allocated CHS nurses |
Primary outcome
Clinical Cultural Competence Training Questionnaire
Time frame: the questionnaire are given before and directly after the educational intervention
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
Time frame: the questionnaire are given before and directly after the educational intervention
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.
4 secondary outcomes
mothers offered to participate in screening
Time frame: before the educational intervention are given and one year after the educational intervention are given
mothers participating in screening
Time frame: before the educational intervention are given and one year after the educational intervention are given
screening with help of interpreter
Time frame: before the educational intervention are given and one year after the educational intervention are given
mothers offered follow-up after screening
Time frame: before the educational intervention are given and one year after the educational intervention are given
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 3651732Cox 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 publication: PubMed 21984467Love 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.
- Derived from this study: PubMed 35524434Skoog 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.
- European Community contract no. 2013 62 09Link provided by the sponsor.
- Medical Research Councils framework for complex interventionsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Since this is a small pilot study a study protocol will not be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inger Kristensson Hallström, professor study chair
Lund University, Faculty of Medicine, Department of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in clinical competence in detecting signs of postpartum depression in immigrant mothers in people with Depression, Postpartum, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cultural Competence Training Questionnaire (time frame: the questionnaire are given before and directly after the educational intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167709, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.