Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07162493

ATTACH in Denmark: A Feasibility Randomized Controlled Trial

Led by Johanne Smith-Nielsen · Updated on 2025-09-23

52

Participants Needed

3

Research Sites

121 weeks

Total Duration

On this page

Sponsors

J

Johanne Smith-Nielsen

Lead Sponsor

U

University of Calgary

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center. The main questions the trial aims to answer are: * How many eligible parents agree to participate in the random allocation to treatment? * How many parents allocated to receive "ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)? * How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills? * Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)? Researchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark. Participants will: 1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills. 2. Be randomly allocated to receive treatment in their local family center with or without ATTACH. 3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received. 4. After one year, the research group will follow up on the current treatment/support needs of the families, who were allocated to either group.

CONDITIONS

Official Title

ATTACH in Denmark: A Feasibility Randomized Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged 0 to 5.7 years at enrollment
  • Speaks Danish or English sufficiently to participate without an interpreter
  • Both parents provide consent if there is shared custody
  • Parents experience psychosocial problems resulting in referral to a family treatment center under Danish Child Act Sections 29, 30, or 32
  • Parents may have children in out-of-home placement or foster care
  • Parental psychosocial issues can include mental health, cognitive difficulties, substance abuse, poverty, social isolation, adverse childhood experiences, functional or somatic disorders, criminal involvement, domestic violence, or children with emotional, developmental, functional, or behavioral problems
Not Eligible

You will not qualify if you...

  • Child older than 5.7 years at enrollment
  • Parent does not speak Danish or English sufficiently without an interpreter
  • Consent from both parents cannot be obtained if custody is shared
  • Parent is known to move to a different municipality within 5 months from randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Center for Sociale Indsatser

Gribskov, Denmark, 3200

Actively Recruiting

2

Poppelgården Familiecenter

Hvidovre, Denmark, 2650

Actively Recruiting

3

Familie- og Dagtilbudscenter

Høje Taastrup, Denmark, 2630

Actively Recruiting

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Research Team

K

Katrine Isabella Wendelboe, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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