Status:
RECRUITING
ATTACH in Denmark: A Feasibility Randomized Controlled Trial
Lead Sponsor:
Johanne Smith-Nielsen
Collaborating Sponsors:
University of Calgary Cumming School of Medicine
Conditions:
Mentalization
Recruitment of Participants
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program "ATTACH(TM) increases mental...
Detailed Description
See the attached project protocol for a detailed description
Eligibility Criteria
Inclusion
- Inclusion criteria
- Child aged 0 - 5.7 years at enrollment.
- Speaks Danish or English sufficiently to take part in assessments and intervention without an interpreter.
- Both parents provide consent in case of shared child custody. Parents experience psycho-social problems that have resulted in referral to the family treatment center on the basis of legislation from the Danish Child Act ("Barnets Lov"), under the following Sections defining support needs: Section 29: Family counselling: Includes open access to family counselling as an early preventive effort. In this context, the counselling may involve referring the family to other departments within the municipality or to other relevant authorities that can provide the appropriate guidance and support. Section 30: Early preventive intervention: Includes a variety of approaches, such as consultancy services and participation in network or discussion groups to address and prevent challenges faced by the family at an early stage. Section 32: Supportive interventions: May be initiated on the basis of a preliminary assessment or a child welfare investigation pursuant to Sections 19 and 20 of the Child Act, or concurrently with the completion of such an assessment or investigation. Support may include practical, pedagogical, or other types of support in the home; appointment of a permanent contact person for the entire family; family therapy or individual treatment for the child or young person; family placement involving residential care in a foster family, an approved child and youth residential facility, or a housing facility; supportive placement in a foster family or in an approved child and youth residential facility; other forms of assistance aimed at providing counseling, treatment, and practical and pedagogical support.
- Parents who have their child in out-of-home placement /foster care (with or without consent).
- Parental psychosocial problems such as (but are not limited to) mental health problems, cognitive difficulties, substance abuse, poverty, social isolation, adverse childhood experiences, functional or somatic disorders, criminal involvement, domestic violence, having a child with emotional regulation difficulties, having a child with developmental problems, having a child with functional or somatic problems, having a child with internalizing or externalizing problems.
- Exclusion Criteria:
- Child is older than 5.7 years at enrollment.
- Parent does not speak Danish or English sufficiently to take part in assessments and intervention without an interpreter.
- Consent cannot be obtained from both parents in case of shared child custody.
- The parent is known to move to a different municipality within 5 months from randomization.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07162493
Start Date
September 1 2025
End Date
December 31 2027
Last Update
September 23 2025
Active Locations (3)
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1
Center for Sociale Indsatser
Gribskov, Denmark, 3200
2
Poppelgården Familiecenter
Hvidovre, Denmark, 2650
3
Familie- og Dagtilbudscenter
Høje Taastrup, Denmark, 2630