- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494128
Early Group Based Parental Support Within Child Health Service - Group Leadership
March 9, 2016 updated by: Lund University
All parents in Sweden are offered group based parental support within Child Health Service (CHS) but only 40% participate.
Nurses feel insecure in their group leadership and express a need for education in group leadership and group dynamics.
Most CHC nurses do not have formal education or training in group leadership and the aim of this study was to evaluate a group based education program in group leadership for Child Health Care (CHC) nurses.
Study Overview
Detailed Description
The study follows the guidelines for complex interventions (MRC) and was set up as a randomized controlled trial (RCT) evaluated with questionnaires before and after the intervention.
Focus group interviews 6 months after the intervention will be performed with the CHC nurses participating in intervention group.
3 groups with 25 CHC nurses in each group are to participate in a three day education in group leadership and group processes.
The education aims to provide knowledge and awareness about group dynamics, group processes and group leadership and also aims towards increased self-awareness in the role as group leader.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- working within child health service in Skåne, Sweden
- managing at least 2 parental groups/year
Exclusion Criteria:
- no parental groups
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention group
Education in group leadership
|
Education in group leadership
|
|
No Intervention: Control group
This group fills in the questionnaire.
No intervention given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in experience of group leadership
Time Frame: 2 weeks before and 6 months after the education
|
Change in experience of group leadership will be measured by a previously used questionnaire (Wallby, T (2008) parental support un Sweden today - What, when and how.
Swedish National Institute of Public Health.
(Föräldrastöd i Sverige idag - Vad när hur?) and Lefevre et al, 2013.
Managing parental groups during early childhood: New challenges faced by Swedish child health nurses.
Journal of child health care).The questionnaire consists of 38 questions concerning structure, content and extent of parental groups as well as questions about group leadership and background characteristics.
Analysis will be performed using Statistical Package for Social Sciences (SPSS) and will be presented in a descriptive way
|
2 weeks before and 6 months after the education
|
|
Relevance and experience of the education in group leadership
Time Frame: After completed intervention, intervention has an expected average duration of 12 weeks.
|
A course evaluation form previously used in educations with primary health care nurses will be completed after the intervention is completed, before leaving site.
It consists of seven questions about the content and relevance of the course.Four questions were arranged with a 5-point Likert scale ranging from 1 "poor" to 5 "excellent", and three questions were open-ended given the possibility to respond in free text.The numeric questions will be summarised and presented descriptive and the answers in text will be analysed by content analysis in a manifest way.
|
After completed intervention, intervention has an expected average duration of 12 weeks.
|
|
Change in experience of group leadership and relevance and experience of the education in group leadership
Time Frame: 6 months after the education
|
Change in experience of group leadership and relevance and experience of the education in group leadership will be explored in Focus group interviews with at least 3 focus groups.
The interviews will be analysed by manifest and latent content analyses.
|
6 months after the education
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Inger Hallström, Professor, Child, family and reproductive health, University Lund
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Silva JAM, Mininel VA, Fernandes Agreli H, Peduzzi M, Harrison R, Xyrichis A. Collective leadership to improve professional practice, healthcare outcomes and staff well-being. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD013850. doi: 10.1002/14651858.CD013850.pub2.
- Lefevre A, Lundqvist P, Drevenhorn E, Hallstrom I. "From resistance to challenge": child health service nurses experiences of how a course in group leadership affected their management of parental groups. BMC Nurs. 2017 Dec 2;16:73. doi: 10.1186/s12912-017-0267-6. eCollection 2017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
May 4, 2015
First Submitted That Met QC Criteria
July 9, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Estimate)
March 10, 2016
Last Update Submitted That Met QC Criteria
March 9, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H152014/397
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Two articles will be published presenting the results.
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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