NCT05196724

Brief Summary

The aim of this study is to examine the effects of Mentalization Based Therapy (MBT) for foster families in Denmark on child mental health and well-being, parental stress, mental health, and reflective function, parental mind-mindedness and the parent-child relationship.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

December 16, 2021

Last Update Submit

November 12, 2024

Conditions

Keywords

Foster careMentalizationTherapyAttachmentEffects

Outcome Measures

Primary Outcomes (1)

  • Child mental health

    The Child Behavior Checklist (CBCL) measures behavioral and emotional problems in children and adolescents. The CBCL consists of 113 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). The CBCL is completed by foster parents for all children in the trial, and the Youth Self-Report (YSR) is completed by the foster children or adolescents aged 11 and above. The CBCL is widely used and has proven to be a useful tool for detecting psychopathology in children and shows good results regarding both validity and reliability

    post-intervention (16 weeks)

Secondary Outcomes (15)

  • Child Mental health

    Follow-up (6 months post-intervention)

  • Child well-being

    post-intervention (16 weeks)

  • Child well-being

    follow-up (6 months post-intervention)

  • Parental reflective function

    post-intervention (16 weeks)

  • Parental reflective function

    follow-up (6 months post-intervention)

  • +10 more secondary outcomes

Study Arms (2)

Mentalization Based Therapy (MBT)

EXPERIMENTAL

MBT for foster carers is a 12 session therapeutic intervention that will be offered to foster families by municipal foster care consultants

Behavioral: Mentalization Based Therapy MBT

Usual care

ACTIVE COMPARATOR

the control group will receive the usual care offered to foster families such as supervision

Behavioral: Usual care

Interventions

The focus is on improving the core components of secure attachment, particularly by developing the reflective functioning for all professionals working with children in out-of-home care, which is subsequently proposed to increase the psychosocial adjustment of the child and decrease emotional and behavioral problems. MBT treatment consists of up to 12 weekly sessions with the foster parents and child covering three core components: 1) psycho-education about mentalizing, trauma, and attachment for foster parents; 2) support for reflective practice in the professional network, and 3) mentalization-based therapy for the foster family \[41\].

Mentalization Based Therapy (MBT)
Usual careBEHAVIORAL

The control group will receive the usual care offered to foster families such as supervision

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any kind of foster family (including professional and kinship care) with at least one full-time foster child aged 4-17 years.
  • Elevated child symptoms as measured by X scales and
  • An expressed need for support from either the foster parents or the foster child.

You may not qualify if:

  • Foster families in which there are no reported difficulties and concerns regarding the child or the placement.
  • Foster families in which the child was placed with the family within the last X months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIVE - The Danish Centre of Social Science Research

Copenhagen, 1052, Denmark

Location

Related Publications (1)

  • Dalgaard NT, Villumsen AMA, Sorensen KM, Midgley N, Vaever MS, Almlund M, Pontoppidan M. Holding a foster child's mind in mind: study protocol for a cluster-randomized controlled trial of mentalization-based therapy (MBT) for foster families. BMC Psychol. 2023 Mar 7;11(1):62. doi: 10.1186/s40359-023-01103-8.

MeSH Terms

Conditions

Mental Disorders

Interventions

Mentalization-Based Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maiken Pontoppidan, PhD

    VIVE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be blinded for allocation when coding story stem and video outcomes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective cluster-randomized controlled trial with two conditions: (1) an intervention group who will receive MBT and (2) and a control group who receive usual care (UC).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 19, 2022

Study Start

August 1, 2022

Primary Completion

November 12, 2024

Study Completion

May 31, 2025

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

The datasets generated and analyzed during the study are not publicly available to protect participant privacy but are available from the corresponding author on reasonable request.

Locations