ATTACH in Denmark: A Feasibility Randomized Controlled Trial

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.

NCT Number	NCT07162493
Lead Sponsor	Johanne Smith-Nielsen Collaborators: University of Calgary
Conditions	Mentalization, Recruitment of Participants, Adherence, Treatment, Drop Out, Parenting Intervention, Vulnerable Families, Feasibility Studies
Enrollment	52 participants
Start Date	2025-09-01
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-23