Vulnerable Families Clinical Trial
— FCDOfficial title:
The Effectivenes of Family Club Denmark #Strongertogether
| Verified date | February 2023 |
| Source | VIVE - The Danish Center for Social Science Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of the trial is to assess the effectiveness of the volunteer intervention Family Club Denmark (FCD)
| Status | Completed |
| Enrollment | 509 |
| Est. completion date | January 31, 2022 |
| Est. primary completion date | January 31, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Family with at least one child 2-12 years old. Exclusion Criteria: - Not able to fill out questionnaires in Danish |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | FDF | Copenhagen | |
| Denmark | KFUM spejderne | Copenhagen | |
| Denmark | KFUMs sociale arbejde | Strib |
| Lead Sponsor | Collaborator |
|---|---|
| VIVE - The Danish Center for Social Science Research | FDF, KFUM spejderne, KFUMs Sociale Arbejde |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 (a =.83) and hostile/coercive (a =.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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |