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RECRUITING

NCT07162493

ATTACH in Denmark: A Feasibility Randomized Controlled Trial

Sponsor: Johanne Smith-Nielsen

View on ClinicalTrials.gov

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.

Official title: Attachment and Child Health (ATTACH) Added to Treatment As Usual Versus Treatment As Usual Alone for Parents With Psychosocial Problems: A Feasibility Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2027-12-31

Last Updated

2025-09-23

Healthy Volunteers

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.

Inclusion criteria * 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. Exclusion Criteria: * 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.

Locations (3)

Center for Sociale Indsatser

Gribskov, Denmark

Poppelgården Familiecenter

Hvidovre, Denmark

Familie- og Dagtilbudscenter

Høje Taastrup, Denmark