Holding a Foster Child's Mind in Mind
Primary Purpose
Attachment Disorder, Behavior Problem
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mentalization Based Therapy MBT
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Attachment Disorder focused on measuring Foster care, Mentalization, Therapy, Attachment, Effects
Eligibility Criteria
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
Sites / Locations
- VIVE - The Danish Centre of Social Science ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mentalization Based Therapy (MBT)
Usual care
Arm Description
MBT for foster carers is a 12 session therapeutic intervention that will be offered to foster families by municipal foster care consultants
the control group will receive the usual care offered to foster families such as supervision
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
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)
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)
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.
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.
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
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
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.
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.
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".
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".
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
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
Full Information
NCT ID
NCT05196724
First Posted
December 16, 2021
Last Updated
February 2, 2023
Sponsor
VIVE - The Danish Center for Social Science Research
Collaborators
University of Copenhagen, University College Copenhagen, Anna Freud National Centre for Children and Families
1. Study Identification
Unique Protocol Identification Number
NCT05196724
Brief Title
Holding a Foster Child's Mind in Mind
Official Title
Holding a Foster Child's Mind in Mind
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVE - The Danish Center for Social Science Research
Collaborators
University of Copenhagen, University College Copenhagen, Anna Freud National Centre for Children and Families
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attachment Disorder, Behavior Problem
Keywords
Foster care, Mentalization, Therapy, Attachment, Effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes assessor will be blinded for allocation when coding story stem and video outcomes
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mentalization Based Therapy (MBT)
Arm Type
Experimental
Arm Description
MBT for foster carers is a 12 session therapeutic intervention that will be offered to foster families by municipal foster care consultants
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
the control group will receive the usual care offered to foster families such as supervision
Intervention Type
Behavioral
Intervention Name(s)
Mentalization Based Therapy MBT
Intervention Description
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].
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
The control group will receive the usual care offered to foster families such as supervision
Primary Outcome Measure Information:
Title
Child mental health
Description
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
Time Frame
post-intervention (16 weeks)
Secondary Outcome Measure Information:
Title
Child Mental health
Description
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
Time Frame
Follow-up (6 months post-intervention)
Title
Child well-being
Description
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.
Time Frame
post-intervention (16 weeks)
Title
Child well-being
Description
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.
Time Frame
follow-up (6 months post-intervention)
Title
Parental reflective function
Description
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)
Time Frame
post-intervention (16 weeks)
Title
Parental reflective function
Description
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)
Time Frame
follow-up (6 months post-intervention)
Title
Parent-child interaction
Description
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.
Time Frame
post-intervention (16 weeks)
Title
Attachment
Description
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.
Time Frame
post-intervention (16 weeks)
Title
Parental stress
Description
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
Time Frame
post-intervention (16 weeks)
Title
Parental stress
Description
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
Time Frame
follow-up (6 months post-intervention)
Title
Parent mental health
Description
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.
Time Frame
post-intervention (16 weeks)
Title
Parent mental health
Description
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.
Time Frame
follow-up (6 months post-intervention)
Title
Parental mind-mindedness
Description
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".
Time Frame
post-intervention (16 weeks)
Title
Parental mind-mindedness
Description
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".
Time Frame
follow-up (6 months post-intervention)
Title
Perception of the family
Description
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
Time Frame
post-intervention (16 weeks)
Title
Perception of the family
Description
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
Time Frame
follow-up (6 months post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maiken Pontoppidan, PhD
Phone
+4533697720
Email
mpo@vive.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Nina T Dalgaard, PhD
Email
nitd@vive.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maiken Pontoppidan, PhD
Organizational Affiliation
VIVE
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIVE - The Danish Centre of Social Science Research
City
Copenhagen
ZIP/Postal Code
1052
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maiken Pontoppidan, ph.d.
Phone
+4533697720
Email
mpo@vive.dk
First Name & Middle Initial & Last Name & Degree
Maiken W Pontoppidan, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Holding a Foster Child's Mind in Mind
We'll reach out to this number within 24 hrs