- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05196724
Holding a Foster Child's Mind in Mind
November 12, 2024 updated by: VIVE - The Danish Center for Social Science Research
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Children placed in foster care are psychologically and physically vulnerable and show more social, developmental, and behavioral problems than children living with their family of origin.
Many foster parents struggle to care for these children, some of whom have experienced serious adversity at a young age.
The study examines the effects of Mentalization Based Therapy (MBT) in a cluster-randomized controlled trial with 175 foster families with children aged 4-17 years in 10 Danish municipalities.
Study Type
Interventional
Enrollment (Estimated)
175
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 1052
- VIVE - The Danish Centre of Social Science Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mentalization Based Therapy (MBT)
MBT for foster carers is a 12 session therapeutic intervention that will be offered to foster families by municipal foster care consultants
|
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].
|
|
Active Comparator: Usual care
the control group will receive the usual care offered to foster families such as supervision
|
The control group will receive the usual care offered to foster families such as supervision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child mental health
Time Frame: post-intervention (16 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Mental health
Time Frame: Follow-up (6 months post-intervention)
|
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
|
Follow-up (6 months post-intervention)
|
|
Child well-being
Time Frame: post-intervention (16 weeks)
|
Kidscreen-10 is a 10-item measure of child well-being health-related quality of health).
Items are scored from 1 (never) to 5 (always) except for items 1 and 9 (reverse).
A higher score is better.
Kidscreen-10 is used with families where the target foster child is 8 years old or more.
|
post-intervention (16 weeks)
|
|
Child well-being
Time Frame: follow-up (6 months post-intervention)
|
Kidscreen-10 is a 10-item measure of child well-being health-related quality of health).
Items are scored from 1 (never) to 5 (always) except for items 1 and 9 (reverse).
A higher score is better.
Kidscreen-10 is used with families where the target foster child is 8 years old or more.
|
follow-up (6 months post-intervention)
|
|
Parental reflective function
Time Frame: post-intervention (16 weeks)
|
Parental Reflective Functioning Questionnaire - PRFQ is an 18 item measure of parental reflective function.
The PRFQ consists of three subscales with score ranges 6-42: 1) Pre-Mentalizing Modes (PRFQ-PM) 6 items (a low score indicates better function).
2) Certainty about Mental States (PRFQ-CMS) 6 items (a medium score indicates better function).
3) Interest and curiosity in mental states PRFQ-IC 6 items (a high score indicates better function)
|
post-intervention (16 weeks)
|
|
Parental reflective function
Time Frame: follow-up (6 months post-intervention)
|
Parental Reflective Functioning Questionnaire - PRFQ is an 18 item measure of parental reflective function.
The PRFQ consists of three subscales with score ranges 6-42: 1) Pre-Mentalizing Modes (PRFQ-PM) 6 items (a low score indicates better function).
2) Certainty about Mental States (PRFQ-CMS) 6 items (a medium score indicates better function).
3) Interest and curiosity in mental states PRFQ-IC 6 items (a high score indicates better function)
|
follow-up (6 months post-intervention)
|
|
Parent-child interaction
Time Frame: post-intervention (16 weeks)
|
To assess the foster parent-child relationship, the study uses the video-based system Coding Interactive Behavior (CIB).
The CIB is a global rating system for social interactions that includes 22 parent codes, 16 child codes, and 5 dyadic codes rated on a scale of 1 to 5 which can be aggregated into the following composites: sensitivity, intrusiveness, limit setting, involvement, withdrawal, compliance, dyadic reciprocity, and dyadic negative states.
The CIB is coded based on a 6-minute parent/child free-play or interaction recorded in the home or at another location if preferred by the family.
The CIB system has been validated as an assessment measure in multiple studies of mother-child interactions in both normative and high-risk populations and shows stability over time, predictive validity, and adequate psychometric properties.
The video will be with the child and one of the foster parents.
The foster parents are free to choose which parent participates.
|
post-intervention (16 weeks)
|
|
Attachment
Time Frame: post-intervention (16 weeks)
|
The Story Stem Assessment Profile (SSAP) is a narrative-based measure, for the assessment of internal representations in children between the ages of 4 and 11 years old.
Using a standard doll family and play materials, the interviewer enacts the beginning of a story (a story stem) and asks the child to complete the story using the provided play materials.
The method allows the child to enact the story in a playful manner creating a narrative based on both verbal and nonverbal inputs, offering a unique insight into the child's perception of the nature and quality of relationships.
The short version of the SSAP entails a set of 7 story stems, which introduce the beginning of a story for the child to complete, within which lies "an inherent dilemma."
The SSAP has demonstrated robust psychometric properties and has been validated with children in out-of-home-care the UK.
|
post-intervention (16 weeks)
|
|
Parental stress
Time Frame: post-intervention (16 weeks)
|
The Parenting Stress Scale (PSS) [52,53] is an 18 item measure of parenting stress that is rated on a five-point scale (Strongly disagree, Disagree, Undecided, Agree, Strongly agree).
Total score range 18-90, where a low score indicates less stress
|
post-intervention (16 weeks)
|
|
Parental stress
Time Frame: follow-up (6 months post-intervention)
|
The Parenting Stress Scale (PSS) [52,53] is an 18 item measure of parenting stress that is rated on a five-point scale (Strongly disagree, Disagree, Undecided, Agree, Strongly agree).
Total score range 18-90, where a low score indicates less stress
|
follow-up (6 months post-intervention)
|
|
Parent mental health
Time Frame: post-intervention (16 weeks)
|
The WHO-5 index is a short questionnaire assessing emotional well-being in adults during the previous 2 weeks.
It consists of five positively formulated items.
The degree to which these feelings were present in the last 2 weeks is scored on a 6-point Likert-type scale ranging from 0 (not present) to 5 (constantly present).
Item scores are summated and transformed to a 0-100 scale, with lower scores indicating poorer well-being.
The WHO-5 index has been cross-culturally validated and has proven to be psychometrically sound.
|
post-intervention (16 weeks)
|
|
Parent mental health
Time Frame: follow-up (6 months post-intervention)
|
The WHO-5 index is a short questionnaire assessing emotional well-being in adults during the previous 2 weeks.
It consists of five positively formulated items.
The degree to which these feelings were present in the last 2 weeks is scored on a 6-point Likert-type scale ranging from 0 (not present) to 5 (constantly present).
Item scores are summated and transformed to a 0-100 scale, with lower scores indicating poorer well-being.
The WHO-5 index has been cross-culturally validated and has proven to be psychometrically sound.
|
follow-up (6 months post-intervention)
|
|
Parental mind-mindedness
Time Frame: post-intervention (16 weeks)
|
To assess representational Mind-mindedness we will use the mind-mindedness interview, addressing the foster carer's tendency to spontaneously think of the child as a psychological being.
The foster carers will be asked to describe their child, and their answers are coded following the manual.
The number of produced sentences about the child's mental characteristics (instead of sentences related to the child's behavior, physical or situational aspects) provides an indication of the level of the caregiver's mental representation of the child, or "representational mind-mindedness".
|
post-intervention (16 weeks)
|
|
Parental mind-mindedness
Time Frame: follow-up (6 months post-intervention)
|
To assess representational Mind-mindedness we will use the mind-mindedness interview, addressing the foster carer's tendency to spontaneously think of the child as a psychological being.
The foster carers will be asked to describe their child, and their answers are coded following the manual.
The number of produced sentences about the child's mental characteristics (instead of sentences related to the child's behavior, physical or situational aspects) provides an indication of the level of the caregiver's mental representation of the child, or "representational mind-mindedness".
|
follow-up (6 months post-intervention)
|
|
Perception of the family
Time Frame: post-intervention (16 weeks)
|
the general functioning subscale of the Family Assessment Device (FAD) is a 6-item subscale to measure the perception of the family function.
It is scored on a 4-point Likert scale.
Items are summed to a total subscale score
|
post-intervention (16 weeks)
|
|
Perception of the family
Time Frame: follow-up (6 months post-intervention)
|
the general functioning subscale of the Family Assessment Device (FAD) is a 6-item subscale to measure the perception of the family function.
It is scored on a 4-point Likert scale.
Items are summed to a total subscale score
|
follow-up (6 months post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maiken Pontoppidan, PhD, VIVE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
November 12, 2024
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
December 16, 2021
First Submitted That Met QC Criteria
January 18, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Estimated)
November 13, 2024
Last Update Submitted That Met QC Criteria
November 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 301703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Behavior Problem
-
Kastamonu UniversityThe Scientific and Technological Research Council of TurkeyRecruiting
-
McMaster UniversityUniversity of Manitoba; Institute for Clinical Evaluative Sciences; University... and other collaboratorsCompleted
-
University of CyprusUnknown
-
Imperial College LondonNational Institute for Health Research, United KingdomCompletedMental Health Disorder | Child Behavior Problem | Self Injurious Behavior | Adolescent Behavior ProblemUnited Kingdom
-
Children's Hospital Los AngelesNational Center for Advancing Translational Sciences (NCATS); AltaMed Health...TerminatedParenting | Child Behavior Problem | Child RearingUnited States
-
Helsinki University Central HospitalCompletedChild Behavior Problem
-
Sykehuset TelemarkEnrolling by invitationChild Behavior Problem | Psychiatric Problem | DDP | Child Neglect | MaltreatmentNorway
-
Muhammad IrfanUniversity of PeshawarCompletedBehavior Problem | Emotional ProblemPakistan
-
Boston University Charles River CampusNational Center for Complementary and Integrative Health (NCCIH)RecruitingMental Health Wellness 1 | Adolescent Behavior ProblemUnited States
-
University of PennsylvaniaCompletedChild Behavior Problem | Interprofessional Relations | Multidisciplinary CommunicationUnited States
Clinical Trials on Mentalization Based Therapy MBT
-
University Hospital HeidelbergVereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen-...Not yet recruitingOppositional Defiant Disorder | Conduct Disorders in AdolescenceGermany
-
University of NottinghamDerbyshire Healthcare NHS Foundation TrustCompletedBorderline Personality Disorder | Older Adults | Attachment | Mentalization | Mentalisation | Later LifeUnited Kingdom
-
Psychiatric Research Unit, Region Zealand, DenmarkCompletedBorderline Personality DisorderDenmark
-
University of MinhoPsychology Research Center (CIPsi)Active, not recruitingChild's Internalizing and Externalizing ProblemsPortugal
-
Universidad de ValparaisoUniversity Diego PortalesRecruiting
-
Eva RüfenachtNot yet recruitingBorderline Personality Disorder (BPD) | PTSD - Post Traumatic Stress DisorderSwitzerland
-
Heidelberg UniversityGerman Research Foundation; Universitätsklinikum Düsseldorf; Psychologische Hochschule... and other collaboratorsRecruitingBorderline Personality DisorderGermany
-
Anna FreudUniversity of HertfordshireRecruitingViolent Behavior | Conduct Disorder | Adolescent Behavior | Aggressive Behaviour | Children Behavior | Mentalization Based TherapyUnited Kingdom
-
Istanbul Bilgi UniversityThe Scientific and Technological Research Council of Turkey; Anna Freud National...CompletedMental Disorder, ChildTurkey
-
University of California, Los AngelesAmerican Foundation for Suicide PreventionCompletedBipolar Disorder | Suicidal IdeationUnited States