ATTACH in Denmark: A Feasibility Randomized Controlled Trial

NCT07162493 | Recruiting

• 1 other identifier: AID-RCT-2025
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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 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:
• Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills.
• Be randomly allocated to receive treatment in their local family center with or without ATTACH.
• 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.
• 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

Keywords

parenting; mentalizing; intervention; feasibility

Outcome Measures

Primary Outcomes (2)

• Feasibility outcomes

  As this is a feasibility trial, the primary aim is to assess feasibility rather than efficacy. We have therefore pre-defined three criteria that will guide our evaluation of whether a future large-scale trial is feasible: 1. Inclusion proportion: At least 25% of eligible parents consent to participation and randomization. 2. Compliance proportion: At least 50% of parents randomized to the ATTACH group complete ≥7 of 10 sessions. 3. Completion proportion: At least 70% of randomized participants provide complete data on the primary clinical exploratory outcome at 5 months.

  We will assess the proportion of three criteria at 5 months after randomization in both arms.

• Primary clinical exploratory outcome - parental mentalizing/insightfulness

  Parents are assessed for their mentalizing capacity using the Parental Insightfulness Assessment interview (IA). Parental insightfulness is defined as the capacity to see things from the child's point of view. The IA is conducted as follows: 1) Video recordings of parent and child interacting. 2) Reviewing 2x2 minute video segments with the parent while conducting the interview. 3) transcription and coding of interview. The interview procedure has been modified to be in accordance with the trial's videorecording procedures, which originally includes reviewing of three video segments, while for this trial, we will include two video segments. The IA consists of 10 different scales, each given a score on a 9-point scale (low to high). Based on the scale scores, the parent is classified into one of four categories: Positively Insightful; One-sided; Disengaged; or Mixed. However, for this study, we will use scale scores from 1 to 9 as the primary indication of parental mentalizing capacity

  IA is assessed at baseline prior to randomization and again at 5 months post randomization.

Secondary Outcomes (11)

• Parental Reflective Functioning

  Assessed at baseline prior to randomization and at 5 months post randomization

• Reflective functioning, general

  Assessed at baseline prior to randomization and at 5 months post randomization

• Parental Mind-Mindedness

  Assessed at baseline prior to randomization and at 5 months post randomization

• Parent-child interaction quality, free-play

  Assessed at baseline prior to randomization and at 5 months post randomization

• Parent-child interaction quality, teaching situation

  Assessed at baseline prior to randomization and at 5 months post randomization

Other Outcomes (1)

• Support needs of family one year after randomization

  Assessed one year post randomization

Study Arms (2)

ATTACH(TM) parenting program added to treatment as usual

EXPERIMENTAL

Developed in Canada by Professor Nicole Letourneau and Dr. Martha Hart, the Attachment and Child Health (ATTACH) parenting program is an intervention for parents of children aged 0-5 years, aiming at improving parental mentalizing skills. It is a manualized, short-term intervention consisting of 10 sessions. Although it can function as a stand-alone intervention, ATTACH has been developed and tested as an add-on to existing practices. Thus, in this trial, the experimental intervention will be ATTACH added to Treatment As Usual.

Behavioral: ATTACH; Behavioral: Treatment as Usual (TAU)

Treatment as usual

ACTIVE COMPARATOR

The control intervention is Treatment As Usual (TAU) provided at the specific trial site, which consists of the standard services and support typically offered to families by the local social- and healthcare systems within municipalities.

Behavioral: Treatment as Usual (TAU)

Interventions

ATTACH BEHAVIORAL

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.

ATTACH(TM) parenting program added to treatment as usual

Treatment as Usual (TAU) BEHAVIORAL

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.

ATTACH(TM) parenting program added to treatment as usual; Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johanne Smith-Nielsen: lead
• University of Calgary Cumming School of Medicine: collaborator

Study Sites (3)

Center for Sociale Indsatser

Gribskov, 3200, Denmark

RECRUITING

Poppelgården Familiecenter

Hvidovre, 2650, Denmark

RECRUITING

Familie- og Dagtilbudscenter

Høje Taastrup, 2630, Denmark

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Johanne Smith-Nielsen, PhD, associate professor

  Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Katrine Isabella Wendelboe, PhD

  Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Nicole Letourneau, PhD, professor

  Faculty of Nursing and Cumming School of Medicine, University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrine Isabella Wendelboe, PhD

CONTACT

+4535334658; katrine.isabella.wendelboe@psy.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Between-subjects design with 1 factor (intervention type) and 2 levels: (a) ATTACH™ + Treatment As Usual and (b) Treatment As Usual alone. Participants are randomized 1:1 using stratified block randomization (municipality, child sex).

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)