Vulnerable FamiliesFCDNCT03657888
The Effectivenes of Family Club Denmark #Strongertogether
A study testing Family Club Denmark (FCD) in people with Vulnerable Families, run by VIVE - The Danish Center for Social Science Research at 3 sites in Denmark.
Trial summary
The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vulnerable Families
- What is being tested?
- Family Club Denmark (FCD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 3 sitesDenmark
- Study dates
- 13 Sep 2018to 31 Jan 2022
- 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
- Family with at least one child 2-12 years old.
Who cannot join
- Not able to fill out questionnaires in Danish
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
FDF
Copenhagen, 1564
KFUM spejderne
Copenhagen, 2450
KFUMs sociale arbejde
Strib, 5500
About this study
The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD)
Read the detailed description
The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD). Participants are 200 vulnerable families with children aged 2-12 years, who would like to participate in a family club.
The study is a prospective controlled trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are allocated to intervention after a first-come-first-serve principle. When the maximum number of participants in a specific family club is reached, any further families will join the wait-list and be offered participation after 6 months.
Most participating families will be characterized by at least one of the following:
- Single parent
- Small or no network
- Low level of support
- Low income
- Physical or mental health problem
- Unemployed
- Loneliness
- Lack of contact with other adults
- Difficulty with creating relationships
- Having a hard time making ends meet during the week
A family club consists of up to 9 families. Most families are vulnerable but each club also includes nun-vulnerable families. The club is run by 3-6 volunteers who have received a 1-day training. Participants meet every two weeks for 6 months (12 sessions).
FCD is based on four principles: 1. Meal community; 2. Play, learning, and togetherness; 3. Support and advice; 4. Bridging to the civil society and the public sector
The 12 sessions center around 7 value posters:
- Fun with smiles
- Together but not in line
- The time is now
- Notice and say thank you
- More than me
- Courage to dare
- Taste the world Data are collected at baseline, and after 6 and 12 months. The study is conducted in the Region South in Denmark.
- Conditions
- Vulnerable Families
- Being tested
- Family Club Denmark (FCD), Wait-list control
- Keywords
- Family, Vulnerable, Volunteer, Child, Civil society, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Club Denmark (FCD)Behavioural
Participation in Family Club Denmark
Wait-list controlOther
Participants on the waiting list
| Study group | Role | What they receive |
|---|---|---|
| Family Club Denmark (FCD) | Experimental | Participation in FCD Receives: Behavioral: Family Club Denmark (FCD) |
| Wait-list | Other | Wait-list control Receives: Other: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
WEMWBS is a 7 item measure of maternal mental health. A total score is calculated by summing the 7 items and converting the raw score according to a published conversion table. Score range 7- 35 for both raw and converted scores. High score is better outcome.
Measured: 6 months
Secondary outcomes (7)
Parent Behavior Inventory (PBI)
(PBI) is a 20 item that measure parenting behaviors in parents of early school-aged children. The PBI includes two subscales with high internal consistency: supportive/engaged (α =.83) and hostile/coercive (α =.81). The PBI has adequate test-retest reliability (r = .69-.74) in an ethnically diverse sample of mothers. To reduce the total number of items we include 10 items - 5 from each of the two subscales: Supportive/Engaged: items 6, 10, 11, 12, 14, and Hostile/Coercive: items 5, 9, 15, 17, 20. Score range is 0-25 for each subscale. High score is better for Supportive/Engaged, low score is better for Hostile/Coercive.
Measured: Baseline, 6 and 12 months
Parental Stress Scale (PSS)
PSS is an 18 item measure of parenting stress that is rated on a five-point scale (Strongly disagree, Disagree, Undecided, Agree, Strongly agree). We use the revised Danish version with 16 items where the original items 2 and 11 are left out. The Danish version consists of two subscales: Parental Stress (9 items) and Lack of Parental Satisfaction (7 items). Responses are reversed for the lack of parental satisfaction items, and all responses for all items are dichotomized (0-1) before scoring. Total score range 0-9 (Parental Stress subscale) and 0-7 (Lack of Parental Stress subscale). A low score is better for both subscales.
Measured: Baseline, 6 and 12 months
General self-efficacy scale (GSE)
GSE is a 10 item measure of optimistic self-beliefs to cope with a variety of difficult demands in life. To reduce the total number of items we include 3 items (8,9, and 10). Score range is 3-12, high score is better.
Measured: Baseline, 6 and 12 months
Self-worth
We use 3 items from the HBSC project to measure self-worth. The 3 items are inspired by Rosenbergs concept of self-esteem. Items are scored from 1 (completely disagree) to 5 (completely agree) and summed. High score is better.
Measured: Baseline, 6 and 12 months
Family routines
We use 5 items (1,4,9,11,21) from the Child Routine Inventory (CDI - 39 item version). Item 1,3,4, and 5 are from the Daily Living Routines subscale and item 2 is from the Household Responsibilities subscale. Inspired by the CDI we developed 5 extra items on family routines around mealtimes and language. Items are scored from 0 (never) to 4 (always). High score is better.
Measured: BAseline, 6 and 12 months
Kidscreen-10
Kidscreen-10 is a 10 item measure of child well-being (health-related quality of health). Items are scored from 1 (never) to 5 (always) except from items 1 and 9 (reverse). Items 1 and 2 explore the level of the child's/adolescent's physical activity, energy and fitness. Items 3 and 4 cover how much the child/adolescent experiences depressive moods and emotions and stressful feelings. Items 5 and 6 ask about the child's opportunities to structure and enjoy his/her social and leisure time and participation in social activities. Item 7 explores the quality of the interaction between child/adolescent and parent or carer and the child's/adolescent's feelings toward their parents/carers. Item 8 examines the nature of the child's/adolescent's relationships with other children/adolescents. Finally, items 9 and 10 explore the child's/adolescent's perception of his/ her cognitive capacity and satisfaction with school performance. Higher score is better
Measured: Baseline, 6 and 12 months
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
WEMWBS is a 7 item measure of maternal mental health. A total score is calculated by summing the 7 items and converting the raw score according to a published conversion table. Score range 7- 35 for both raw and converted scores. High score is better outcome.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start13 Sep 2018
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 Vulnerable FamiliesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective controlled trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- KFUMs Sociale Arbejde, FDF, KFUM spejderne
- Responsible party
- Sponsor
- Investigators
- maiken Pontoppidan, Principal investigator, VIVE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657888
- Sponsor's protocol ID
- VIVE100726
- Acronym
- FCD
- Status last verified
- Feb 2023
- First submitted
- 29 Aug 2018
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the number of participants and the information provided we will decide if individual participant data can be made available or not
Publications
Pontoppidan M, Thorsager M, Larsen AT, Friis-Hansen M. Family Club Denmark: A Quasi-Randomized Study of a Volunteer-Based Intervention to Support Vulnerable Families. Healthcare (Basel). 2024 May 29;12(11):1115. doi: 10.3390/healthcare12111115.
PubMed 38891190Pontoppidan M, Thorsager M, Larsen AT, Friis-Hansen M. Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families: study protocol for a quasi-experimental trial. BMC Psychol. 2020 Jun 1;8(1):55. doi: 10.1186/s40359-020-00426-0.
PubMed 32487180
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivenes of Family Club Denmark #Strongertogether
- ClinicalTrials.gov ID
- NCT03657888
- Acronym / sponsor ID
- FCD / VIVE100726
- Conditions
- Vulnerable Families
- Keywords
- Family, Vulnerable, Volunteer, Child, Civil society, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- KFUMs Sociale Arbejde, FDF, KFUM spejderne
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 5 Sep 2018 (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 of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD)
Detailed description
The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD). Participants are 200 vulnerable families with children aged 2-12 years, who would like to participate in a family club.
The study is a prospective controlled trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group. Participants are allocated to intervention after a first-come-first-serve principle. When the maximum number of participants in a specific family club is reached, any further families will join the wait-list and be offered participation after 6 months.
Most participating families will be characterized by at least one of the following:
- Single parent
- Small or no network
- Low level of support
- Low income
- Physical or mental health problem
- Unemployed
- Loneliness
- Lack of contact with other adults
- Difficulty with creating relationships
- Having a hard time making ends meet during the week
A family club consists of up to 9 families. Most families are vulnerable but each club also includes nun-vulnerable families. The club is run by 3-6 volunteers who have received a 1-day training. Participants meet every two weeks for 6 months (12 sessions).
FCD is based on four principles: 1. Meal community; 2. Play, learning, and togetherness; 3. Support and advice; 4. Bridging to the civil society and the public sector
The 12 sessions center around 7 value posters:
- Fun with smiles
- Together but not in line
- The time is now
- Notice and say thank you
- More than me
- Courage to dare
- Taste the world Data are collected at baseline, and after 6 and 12 months. The study is conducted in the Region South in Denmark.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a prospective controlled trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| Family Club Denmark (FCD) | Experimental | Behavioral: Family Club Denmark (FCD)Participation in FCD |
| Wait-list | Other | Other: Wait-list controlWait-list control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Family with at least one child 2-12 years old.
Key exclusion criteria (1 listed)
- Not able to fill out questionnaires in Danish
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 |
|---|---|---|
| Family Club Denmark (FCD)Participation in Family Club Denmark | Behavioural | Family Club Denmark (FCD) |
| Wait-list controlParticipants on the waiting list | Other | Wait-list |
Primary outcome
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: 6 months
WEMWBS is a 7 item measure of maternal mental health. A total score is calculated by summing the 7 items and converting the raw score according to a published conversion table. Score range 7- 35 for both raw and converted scores. High score is better outcome.
7 secondary outcomes
Parent Behavior Inventory (PBI)
Time frame: Baseline, 6 and 12 months
Parental Stress Scale (PSS)
Time frame: Baseline, 6 and 12 months
General self-efficacy scale (GSE)
Time frame: Baseline, 6 and 12 months
Self-worth
Time frame: Baseline, 6 and 12 months
Family routines
Time frame: BAseline, 6 and 12 months
Kidscreen-10
Time frame: Baseline, 6 and 12 months
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: Baseline and 12 months
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 3 Feb 2023.
- Derived from this study: PubMed 38891190Pontoppidan M, Thorsager M, Larsen AT, Friis-Hansen M. Family Club Denmark: A Quasi-Randomized Study of a Volunteer-Based Intervention to Support Vulnerable Families. Healthcare (Basel). 2024 May 29;12(11):1115. doi: 10.3390/healthcare12111115.
- Derived from this study: PubMed 32487180Pontoppidan M, Thorsager M, Larsen AT, Friis-Hansen M. Family Club Denmark #strongertogether - a volunteer intervention for disadvantaged families: study protocol for a quasi-experimental trial. BMC Psychol. 2020 Jun 1;8(1):55. doi: 10.1186/s40359-020-00426-0.
- Individual participant dataSharing planned: Undecided. Depending on the number of participants and the information provided we will decide if individual participant data can be made available or not
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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.
maiken Pontoppidan principal investigator
VIVE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Club Denmark (FCD) in people with Vulnerable Families, run by VIVE - The Danish Center for Social Science Research at 3 sites in Denmark.
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 1 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (time frame: 6 months). 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 NCT03657888, 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 3 Feb 2023.