Clinical trial NCT03657888: The Effectivenes of Family Club Denmark #Strongertogether
Official title: The Effectivenes of Family Club Denmark #Strongertogether
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulnerable Families
Keywords: Family
Vulnerable
Volunteer
Child
Civil society
Intervention
Lead sponsor: VIVE - The Danish Center for Social Science Research
Sponsor class: OTHER
Collaborators: name: KFUMs Sociale Arbejde
name: FDF
name: KFUM spejderne
First posted: 2018-09-05
Enrollment: 509
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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:

1. Fun with smiles
2. Together but not in line
3. The time is now
4. Notice and say thank you
5. More than me
6. Courage to dare
7. Taste the world Data are collected at baseline, and after 6 and 12 months. The study is conducted in the Region South in Denmark.

Eligibility criteria: Inclusion Criteria:

* Family with at least one child 2-12 years old.

Exclusion Criteria:

* Not able to fill out questionnaires in Danish

Primary outcomes:
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: 6 months
Secondary outcomes:
measure: Parent Behavior Inventory (PBI)
timeFrame: Baseline, 6 and 12 months
measure: Parental Stress Scale (PSS)
timeFrame: Baseline, 6 and 12 months
measure: General self-efficacy scale (GSE)
timeFrame: Baseline, 6 and 12 months
measure: Self-worth
timeFrame: Baseline, 6 and 12 months
measure: Family routines
timeFrame: BAseline, 6 and 12 months
measure: Kidscreen-10
timeFrame: Baseline, 6 and 12 months
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: FDF
city: Copenhagen
country: Denmark
facility: KFUM spejderne
city: Strib
country: Denmark
facility: KFUMs sociale arbejde
Study officials:
affiliation: VIVE
name: maiken Pontoppidan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pontoppidan 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.