NCT03657888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

September 13, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

3.4 years

First QC Date

August 29, 2018

Last Update Submit

February 2, 2023

Conditions

Keywords

FamilyVulnerableVolunteerChildCivil societyIntervention

Outcome Measures

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.

    6 months

Secondary Outcomes (7)

  • Parent Behavior Inventory (PBI)

    Baseline, 6 and 12 months

  • Parental Stress Scale (PSS)

    Baseline, 6 and 12 months

  • General self-efficacy scale (GSE)

    Baseline, 6 and 12 months

  • Self-worth

    Baseline, 6 and 12 months

  • Family routines

    BAseline, 6 and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Family Club Denmark (FCD)

EXPERIMENTAL

Participation in FCD

Behavioral: Family Club Denmark (FCD)

Wait-list

OTHER

Wait-list control

Other: Wait-list control

Interventions

Participation in Family Club Denmark

Family Club Denmark (FCD)

Participants on the waiting list

Wait-list

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not able to fill out questionnaires in Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

FDF

Copenhagen, 1564, Denmark

Location

KFUM spejderne

Copenhagen, 2450, Denmark

Location

KFUMs sociale arbejde

Strib, 5500, Denmark

Location

Related Publications (2)

  • Pontoppidan M, Thorsager M, Larsen AT, Friis-Hansen M. Family Club Denmark: A Quasi-Randomized Study of a Volunteer-Based Intervention to Support Vulnerable Families. Healthcare (Basel). 2024 May 29;12(11):1115. doi: 10.3390/healthcare12111115.

  • 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.

Study Officials

  • maiken Pontoppidan

    VIVE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and volunteers cannot be blinded but data analyst will be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study is a prospective controlled trial with two conditions: (1) intervention group participating in Family Club Denmark and (2) wait-list control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 5, 2018

Study Start

September 13, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations