The Effectivenes of Family Club Denmark #Strongertogether

Study Overview
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Brief Summary
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The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD)

Detailed Description
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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.

Official Title
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The Effectivenes of Family Club Denmark #Strongertogether

Conditions
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Vulnerable Families

Intervention / Treatment
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* Behavioral: Family Club Denmark (FCD)
* Other: Wait-list control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Family with at least one child 2-12 years old. Exclusion Criteria: Not able to fill out questionnaires in Danish
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Club Denmark (FCD)<br>Participation in FCD | Behavioral: Family Club Denmark (FCD)<br>* Participation in Family Club Denmark<br>|
| Other: Wait-list<br>Wait-list control | Other: Wait-list control<br>* Participants on the waiting list<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family, Vulnerable, Volunteer, Child, Civil society, Intervention