CClinicalTrials.gg
CompletedNCT03657888FCDUpdated Feb 3, 2023

The Effectivenes of Family Club Denmark #Strongertogether

An interventional study of Family Club Denmark (FCD) and Wait-list control in Vulnerable Families, sponsored by VIVE - The Danish Center for Social Science Research. Completed at 3 sites in Denmark. Per ClinicalTrials.gov, last updated 2023-02-03.

Sponsored by VIVE - The Danish Center for Social Science Research · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
509
Allocation
Non-randomized
Sex
All
01

Study summary

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:

  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.
02

Conditions studied

  • Vulnerable Families

Keywords

  • Family
  • Vulnerable
  • Volunteer
  • Child
  • Civil society
  • Intervention
03

In context

Lead sponsor

VIVE - The Danish Center for Social Science Research is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not able to fill out questionnaires in Danish
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
509 participants (actual)

Study arms

  • Experimental
    Family Club Denmark (FCD)

    Participation in FCD

    Behavioral: Family Club Denmark (FCD)

  • Other
    Wait-list

    Wait-list control

    Other: Wait-list control

Interventions

  • BehavioralFamily Club Denmark (FCD)

    Participation in Family Club Denmark

  • OtherWait-list control

    Participants on the waiting list

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6 and 12 months

  2. 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.

    Time frame: Baseline, 6 and 12 months

  3. 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.

    Time frame: Baseline, 6 and 12 months

  4. 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.

    Time frame: Baseline, 6 and 12 months

  5. 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.

    Time frame: BAseline, 6 and 12 months

  6. 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

    Time frame: Baseline, 6 and 12 months

  7. 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.

    Time frame: Baseline and 12 months

07

Study locations

3 sites
  • FDF
    Copenhagen, 1564, Denmark
  • KFUM spejderne
    Copenhagen, 2450, Denmark
  • KFUMs sociale arbejde
    Strib, 5500, Denmark
08

References and documents

Publications

  • 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. PubMed 32487180 ↗

Individual participant data

Plan to share: Undecided — Depending on the number of participants and the information provided we will decide if individual participant data can be made available or not

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03657888
Lead sponsor
VIVE - The Danish Center for Social Science Research
Collaborators
KFUMs Sociale Arbejde, FDF, KFUM spejderne
Responsible party
Sponsor
First posted
Sep 5, 2018
Start date
Sep 13, 2018
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
Feb 3, 2023

Study contacts

maiken Pontoppidan
principal investigator · VIVE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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