NCT07162493: AiD

ATTACH in Denmark: A Feasibility Randomized Controlled Trial

Recruiting now NA Last updated 23 September 2025

What this trial tests

NA trial testing ATTACH in Mentalization in 52 participants. Currently enrolling.

Timeline

1 September 2025

Primary endpoint
31 May 2027

31 December 2027

Quick facts

Lead sponsor	Johanne Smith-Nielsen
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	52
Start date	1 September 2025
Primary completion	31 May 2027
Estimated completion	31 December 2027
Sites	3 locations across Denmark

Drugs / interventions tested

• ATTACH
• Treatment as Usual (TAU) — full drug profile →

Conditions studied

• Mentalization — all drugs for Mentalization →
• Recruitment of Participants — all drugs for Recruitment of Participants →
• Adherence, Treatment — all drugs for Adherence, Treatment →
• Drop Out — all drugs for Drop Out →

Sponsor

Johanne Smith-Nielsen

Who can join

18 and older, any sex, with Mentalization or Recruitment of Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.