Holding a Foster Child's Mind in Mind

Behavior Problem Clinical Trial

Official title:

Holding a Foster Child's Mind in Mind

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196724
• Other study ID #: 301703
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2023
• Source: VIVE - The Danish Center for Social Science Research
• Contact: Maiken Pontoppidan, PhD
• Phone: +4533697720
• Email: mpo[@]vive.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: August 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attachment Disorder
• Behavior Problem
• Problem Behavior

Intervention

Behavioral:
• Mentalization Based Therapy MBT
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 care
The control group will receive the usual care offered to foster families such as supervision

Locations

Country	Name	City	State
Denmark	VIVE - The Danish Centre of Social Science Research	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
VIVE - The Danish Center for Social Science Research	Anna Freud National Centre for Children and Families, University College Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Follow-up (6 months post-intervention)
Secondary	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.	post-intervention (16 weeks)
Secondary	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.	follow-up (6 months post-intervention)
Secondary	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)	post-intervention (16 weeks)
Secondary	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)	follow-up (6 months post-intervention)
Secondary	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.	post-intervention (16 weeks)
Secondary	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.	post-intervention (16 weeks)
Secondary	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	post-intervention (16 weeks)
Secondary	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	follow-up (6 months post-intervention)
Secondary	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.	post-intervention (16 weeks)
Secondary	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.	follow-up (6 months post-intervention)
Secondary	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".	post-intervention (16 weeks)
Secondary	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".	follow-up (6 months post-intervention)
Secondary	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	post-intervention (16 weeks)
Secondary	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	follow-up (6 months post-intervention)