The Effectivenes of Family Club Denmark #Strongertogether (FCD)

February 2, 2023 updated by: VIVE - The Danish Center for Social Science Research
The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to fill out questionnaires in Danish

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: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Family Club Denmark (FCD)
Participation in FCD
Behavioral: Family Club Denmark (FCD)
Participation in Family Club Denmark
OTHER: Wait-list
Wait-list control
Other: Wait-list control
Participants on the waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Behavior Inventory (PBI)
Time Frame: Baseline, 6 and 12 months
(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.
Baseline, 6 and 12 months
Parental Stress Scale (PSS)
Time Frame: Baseline, 6 and 12 months
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.
Baseline, 6 and 12 months
General self-efficacy scale (GSE)
Time Frame: Baseline, 6 and 12 months
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.
Baseline, 6 and 12 months
Self-worth
Time Frame: Baseline, 6 and 12 months
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.
Baseline, 6 and 12 months
Family routines
Time Frame: BAseline, 6 and 12 months
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.
BAseline, 6 and 12 months
Kidscreen-10
Time Frame: Baseline, 6 and 12 months
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
Baseline, 6 and 12 months
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame: Baseline and 12 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.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVE - The Danish Center for Social Science Research

Collaborators

KFUMs Sociale Arbejde
FDF
KFUM spejderne

Investigators

  • Principal Investigator: maiken Pontoppidan, VIVE

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

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 (ACTUAL)

September 13, 2018

Primary Completion (ACTUAL)

January 31, 2022

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (ACTUAL)

September 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIVE100726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on the number of participants and the information provided we will decide if individual participant data can be made available or not

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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