ATTACH in Denmark: A Feasibility Randomized Controlled Trial

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 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

• Mentalization
• Recruitment of Participants
• Adherence, Treatment
• Drop Out
• Parenting Intervention
• Vulnerable Families
• Feasibility Studies

Interventions

BEHAVIORAL

ATTACH

ATTACH(TM) is a manualized, 10-session, mentalizing/reflective functioning-based parenting program, with one 45-60-minute weekly session. It is conducted individually with one parent focusing on one child throughout the program; however, a co-parent/parental support person will participate in session 7 and session 9. A session includes three components to facilitate parental reflective functioning: 1)Video-review of parent-child interaction, 2) reflection on a hypothetical situation (pre-defined for each session), and 3) reflection on a mildly stressful situation from the parent's everyday life with the child. The parent's reflective process is supported by handouts, e.g., "emotion cards". All material used in the sessions have been translated into Danish, and the wording have been modified to fit with the cultural context, based on feedback from two pilot studies. ATTACH is facilitated by professionals employed at the family centers, who have been trained and certified in ATTACH.

BEHAVIORAL

Treatment as Usual (TAU)

Treatment As Usual (TAU) consists of the standard services and support typically offered to families by the local social- and healthcare systems within each municipality. These services vary depending on individual needs, risk assessment of the family, and municipal practices, but often include individual and/or group-based parenting support or therapeutic services at the trial site and/or in the parent's home. TAU may also involve referrals to additional resources or interventions deemed necessary by social authorities or healthcare providers (e.g., psychiatric treatment in the region). The control group will not receive the ATTACH™ program but will have access to all relevant standard care options available within their municipality. TAU can be delivered by different professionals, such as health visitors, social workers, family therapists/counsellors or clinical psychologists. For more details on TAU services at each trial site, see the attached project protocol.

Sponsors & Collaborators

• University of Calgary Cumming School of Medicine

  collaborator UNKNOWN

• Johanne Smith-Nielsen

  lead OTHER

Principal Investigators

• Johanne Smith-Nielsen, PhD, associate professor · Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen

• Katrine Isabella Wendelboe, PhD · Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen

• Nicole Letourneau, PhD, professor · Faculty of Nursing and Cumming School of Medicine, University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-05-31

Completion

2027-12-31

Countries

• Denmark

Study Locations