Attachment DisorderNCT05196724
Holding a Foster Child's Mind in Mind
A study testing Mentalization Based Therapy MBT in people with Attachment Disorder and Behavior Problem, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attachment Disorder, Behavior Problem
- What is being tested?
- Mentalization Based Therapy MBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
VIVE - The Danish Centre of Social Science Research
Copenhagen, 1052
About this study
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.
Read the 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.
- Conditions
- Attachment Disorder, Behavior Problem
- Being tested
- Mentalization Based Therapy MBT, Usual care
- Keywords
- Foster care, Mentalization, Therapy, Attachment, Effects
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization Based Therapy MBTBehavioural
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].
Usual careBehavioural
The control group will receive the usual care offered to foster families such as supervision
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mentalization Based Therapy MBT |
| Usual care | Active comparator | the control group will receive the usual care offered to foster families such as supervision Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post-intervention (16 weeks)
Secondary outcomes (15)
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
Measured: Follow-up (6 months post-intervention)
Child well-being
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.
Measured: post-intervention (16 weeks)
Child well-being
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.
Measured: follow-up (6 months post-intervention)
Parental reflective function
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)
Measured: post-intervention (16 weeks)
Parental reflective function
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)
Measured: follow-up (6 months post-intervention)
Parent-child interaction
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.
Measured: post-intervention (16 weeks)
Attachment
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.
Measured: post-intervention (16 weeks)
Parental stress
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
Measured: post-intervention (16 weeks)
Parental stress
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
Measured: follow-up (6 months post-intervention)
Parent mental health
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.
Measured: post-intervention (16 weeks)
Parent mental health
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.
Measured: follow-up (6 months post-intervention)
Parental mind-mindedness
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".
Measured: post-intervention (16 weeks)
Parental mind-mindedness
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".
Measured: follow-up (6 months post-intervention)
Perception of the family
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
Measured: post-intervention (16 weeks)
Perception of the family
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
Measured: follow-up (6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Aug 2022
- Primary completion12 Nov 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attachment DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIVE - The Danish Center for Social Science Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University College Copenhagen, Anna Freud National Centre for Children and Families
- Responsible party
- Sponsor
- Investigators
- Maiken Pontoppidan, PhD, Principal investigator, VIVE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196724
- Sponsor's protocol ID
- 301703
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2021
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36879301
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holding a Foster Child's Mind in Mind
- ClinicalTrials.gov ID
- NCT05196724
- Acronym / sponsor ID
- 301703
- Conditions
- Attachment Disorder, Behavior Problem
- Keywords
- Foster care, Mentalization, Therapy, Attachment, Effects
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- VIVE - The Danish Center for Social Science ResearchUniversity, hospital or other
- Collaborators
- University of Copenhagen, University College Copenhagen, Anna Freud National Centre for Children and Families
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Mentalization Based Therapy (MBT) | Experimental | Behavioral: Mentalization Based Therapy MBTMBT for foster carers is a 12 session therapeutic intervention that will be offered to foster families by municipal foster care consultants |
| Usual care | Active comparator | Behavioral: Usual carethe control group will receive the usual care offered to foster families such as supervision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization Based Therapy MBTThe 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]. | Behavioural | Mentalization Based Therapy (MBT) |
| Usual careThe control group will receive the usual care offered to foster families such as supervision | Behavioural | Usual care |
Primary outcome
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
15 secondary outcomes
Child Mental health
Time frame: Follow-up (6 months post-intervention)
Child well-being
Time frame: post-intervention (16 weeks)
Child well-being
Time frame: follow-up (6 months post-intervention)
Parental reflective function
Time frame: post-intervention (16 weeks)
Parental reflective function
Time frame: follow-up (6 months post-intervention)
Parent-child interaction
Time frame: post-intervention (16 weeks)
Attachment
Time frame: post-intervention (16 weeks)
Parental stress
Time frame: post-intervention (16 weeks)
Parental stress
Time frame: follow-up (6 months post-intervention)
Parent mental health
Time frame: post-intervention (16 weeks)
Parent mental health
Time frame: follow-up (6 months post-intervention)
Parental mind-mindedness
Time frame: post-intervention (16 weeks)
Parental mind-mindedness
Time frame: follow-up (6 months post-intervention)
Perception of the family
Time frame: post-intervention (16 weeks)
Perception of the family
Time frame: follow-up (6 months post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Derived from this study: PubMed 36879301Dalgaard 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiken Pontoppidan, PhD principal investigator
VIVE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization Based Therapy MBT in people with Attachment Disorder and Behavior Problem, run by VIVE - The Danish Center for Social Science Research at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child mental health (time frame: post-intervention (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.