ATTACH in Denmark: A Feasibility Randomized Controlled Trial
NCT ID: NCT07162493
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2025-09-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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ATTACH(TM) parenting program added to treatment as usual
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.
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.
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.
Treatment as usual
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Johanne Smith-Nielsen
OTHER
University of Calgary Cumming School of Medicine
UNKNOWN
Responsible Party
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Johanne Smith-Nielsen
Associate Professor
Principal Investigators
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Johanne Smith-Nielsen, PhD, associate professor
Role: PRINCIPAL_INVESTIGATOR
Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen
Katrine Isabella Wendelboe, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre of Excellence in Early Intervention and Family Studies, Department of Psychology, University of Copenhagen
Nicole Letourneau, PhD, professor
Role: PRINCIPAL_INVESTIGATOR
Faculty of Nursing and Cumming School of Medicine, University of Calgary
Locations
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Center for Sociale Indsatser
Gribskov, , Denmark
Poppelgården Familiecenter
Hvidovre, , Denmark
Familie- og Dagtilbudscenter
Høje Taastrup, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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AID-RCT-2025
Identifier Type: -
Identifier Source: org_study_id
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