Family HealthNCT02494128
Early Group Based Parental Support Within Child Health Service - Group Leadership
A study testing Education in people with Family Health, run by Lund University.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Health
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Mar 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- working within child health service in Skåne, Sweden
- managing at least 2 parental groups/year
Who cannot join
- no parental groups
About this study
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.
Read the 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.
- Conditions
- Family Health
- Being tested
- Education
- Keywords
- Child health service, Family health, Nurse, Education, Parental group, Group leadership, Health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Education in group leadership
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Education in group leadership Receives: Other: Education |
| Control group | No intervention | This group fills in the questionnaire. No intervention given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in experience of group leadership
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
Measured: 2 weeks before and 6 months after the education
Relevance and experience of the education in group leadership
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.
Measured: 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
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.
Measured: 6 months after the education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family HealthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Sponsor
- Investigators
- Inger Hallström, Professor, Principal investigator, Child, family and reproductive health, University Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494128
- Sponsor's protocol ID
- H152014/397
- Status last verified
- Mar 2016
- First submitted
- 4 May 2015
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Two articles will be published presenting the results.
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.
PubMed 36214207Lefevre 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.
PubMed 29213213
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Group Based Parental Support Within Child Health Service - Group Leadership
- ClinicalTrials.gov ID
- NCT02494128
- Acronym / sponsor ID
- H152014/397
- Conditions
- Family Health
- Keywords
- Child health service, Family health, Nurse, Education, Parental group, Group leadership, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: EducationEducation in group leadership |
| Control group | No intervention | –This group fills in the questionnaire. No intervention given. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- working within child health service in Skåne, Sweden
- managing at least 2 parental groups/year
Key exclusion criteria (1 listed)
- no parental groups
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 |
|---|---|---|
| EducationEducation in group leadership | Other | Intervention group |
Primary outcome
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
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.
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.
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 10 Mar 2016.
- Derived from this study: PubMed 36214207Silva 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.
- Derived from this study: PubMed 29213213Lefevre 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.
- Individual participant dataSharing planned: Yes. Two articles will be published presenting the results.
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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 Hallström, Professor principal investigator
Child, family and reproductive health, University Lund
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Family Health, run by Lund University.
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 2 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in experience of group leadership (time frame: 2 weeks before and 6 months after the education). The study lists 3 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 NCT02494128, which also lists 2 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 10 Mar 2016.