Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02497677
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2015-07-07
Brief Title:
Copenhagen Infant Mental Health Project Enhancing Parental Sensitivity and Attachment CIMHP
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Copenhagen Infant Mental Health Project A Randomized Controlled Trial Comparing Circle of Security-Parenting and Care as Usual as Interventions Targeting Infant Mental Healths Risks
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIMHP
Brief Summary:
Infant mental health is a significant public health issue as early adversity and expose to childhood stress has life-long consequences for the affected children Helping families at risk correct their adverse effects on the infant has the potential to halt a negative spiral effect where vulnerable parents fail to cope with an at-risk child - which in turn adds to the childs vulnerability negatively affects the parents and so forth Over a four year period an estimated 17600 dyads will be screened in the City of Copenhagen using standardized screening instruments in detecting infant social withdrawal ADBB and maternal postnatal depression EPDS A sample of 314 eligible parents will enter into a clinical randomized control trial to test the efficacy of an 8 week group counseling program Circle of Security Parenting COS-P compared to Care as UsualCAU in enhancing maternal sensitivity child attachment and cognitive development CIMHP is the first large-scale randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity child attachment and cognitive development in Denmark Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country
Detailed Description:
Background and rationale Infant mental health is a significant public health issue as early adversity and exposure to early childhood stress has life-long consequences for these affected children on outcomes such physical and mental health educational attainment labor market success and family formation Infants are - as a result of their dependency vulnerability and relative social invisibility - more exposed to mental health risks than older children Infants may be at risk due to a particular biological risk eg infantile autism retardation prematurity physical disabilities etc or to psycho-social risks in the family eg mentally ill parents poverty drugalcohol abuse etc Recent Danish estimates suggest that one in five families is at risk of inadequate parenting resources and child neglect
There is by now solid evidence that the establishment of attachment relationships ie a stable emotional bond with a caregiver - mostly the parent - is one of the most important developmental milestones in infancy Early parent-child attachment relationships function as a blueprint for future social relationships and serve as a framework within which children learn how to deal with stressful situations and to regulate the accompanying negative emotions Insecure and disorganized attachment is a significant risk for longitudinal child development and psychopathology as the ability to regulate ones feelings of stress and negative emotions is important for a wide range of socio-emotional outcomes ranging from social competence moral development and empathy to academic achievement Recent meta-analyses show that insecure and disorganized children have a higher risk of developing mental problems later in life Insecurely attached children are also more likely than securely attached children to develop internalizing problems such as anxiety and depressive symptoms as well as externalizing problems such as aggressive behavior For externalizing problems the risk was even higher for disorganized children Furthermore research into early brain development indicates that brain development can be physiologically altered by severe stress imposed by neglect and inadequate parenting during a childs early years
Evidence from attachment research shows that sensitive parenting where the parent is alert and able to understand the infants expression of emotional states and able to manage and meet the infants needs contingently adequately and in a comforting way will lead to the establishment of a pattern of secure attachment in the child Lack of availability inconsistent availability misunderstanding of the infants emotional expression and parental behavior that frightens the infant may all lead to an insure attachment and in the most severe cases a disorganized attachment This is indicative of a breakdown of an organized secure or insecure attachment behavioral strategy Disorganized attachment is considered to be the result of parental behavior that is frightening for the child An extreme example of such behavior is child maltreatment but all sorts of parental behavior that are not comprehensible for the child such as dissociation which is common in depressed parents is potentially frightening for the child This sort of behavior results in the paradoxical situation that the parent is a source of comfort and a source of fear at the same time Thus in stress situations the child does not know what to do and the behavioral strategy collapses
Infant social withdrawal indicates infant distress and early attachment disturbances and is a known risk factor for infant mental health Infant social withdrawal is indicated by a lack of either positive eg smiling eye contact or negative vocal protestations Sustained withdrawal behavior in infants can be seen as a chronic diminution of the attachment system which is gradually generalized into a diminished engagement and lowered reactivity to the environment at large In more European countries the use of the validated systematic screening method Alarm Distress Baby Scale ADBB for identifying infant delayed socio-emotional development in infant mental health clinics and in home visiting programs have shown promising results
Postnatal depression PND is another known risk for infant mental health A meta-analysis shows that up to 19 of new mothers may experience minor or major depression during the first months postpartum If only including major depression the prevalence was found to be 71 In a more recent European study 1066 women were followed from pregnancy to 12 months postpartum The results indicated that 96 of new mothers may experience a major depressive episode during the first year after delivery No estimates were given for minor depression Most cases develop within the first three months with a peak incidence of about 4-6 weeks
PND has a substantial impact on the mother her partner her family mother-baby interactions and attachment insecurity and the longer term socio-emotional and cognitive development of the baby especially when depression occurs in the first year of life Often mothers suffering from postnatal depression are emotionally cognitively andor behaviorally inhibited or impaired in their ability to recognize and react with appropriate sensitivity and responsiveness to their childrens needs With regard to the infants of these mothers higher incidences of negative behaviors such as social withdrawal persistent crying averted gaze or head position physical neediness and a lack of expression of delight in the presence of their mothers have been observed These behaviors increase the mothers experience of stress which further contributes to the maintenance of maladaptive interactional behavioral patterns Without improvement in these negative interaction cycles for example through early interventions there is a greater likelihood for infants to develop an insecure-avoidant an insecure ambivalent or disorganized attachment pattern
Research on the treatment of women with postnatal depression has shown that treatment that only focuses on the mother ie medication psychotherapy is insufficient to buffer against the negative impact of maternal psychopathology on the childs cognitive and psychosocial development as well as infant-mother attachment quality Even when depression is effectively treated this does not seem to spill over and improve the mother-infant relationship and long-term infant social-emotional outcomes Instead it is necessary to support the depressed mothers in their specific needs in caring and relating to their infants
Interventions targeting PND delivered in groups have been found to achieve change through the dual process of emotional experience and reflection in an interpersonal context Group sessions provide a support network reduce isolation and stigma provide an environment in which to practice interpersonal and communication skills shape coping strategies and learn from each other and enable a number of families to be treated at once Recently building on evidence from attachment research a special focus is given to preventive group programs that enhance parental sensitivity and secure attachment such as the intervention program Circle of Security COS Based on findings from more studies COS has proved efficient in enhancing secure attachment as well as reducing maternal depressive symptomatology in high-risk samples including mothers in prison and mentally ill mothers The original COS program consists of 20 weekly sessions of 2 hour durations and includes an initial video assessment of parent -child attachment In the COS intervention graphical illustrations of the Circle of Security are used This Circle is a roadmap that encompasses the three basic control systems the attachment system the exploration system and the caregiving system The parent is illustrated through the pair of hands that hold together the childs world In COS concepts holding means to serve as a secure base and safe haven The top half of the Circle depicts the childs exploration system and needs I order to explore the child needs the parent to serve as a secure base by watching over delighting in helping and enjoying with the child Having a parent that supports exploration helps the child develop his or her own sense of interest leading to mastery and competency in later years Along the bottom half is the childs attachment needs protect me comfort me delight in me and organize my feelings By delighting in the child the parent helps the child constructing an internal representation of him- of herself as a loved person and thereby establish self-worth and by organizing the childs feelings by accepting sharing and naming them the parent co-regulates the childs emotions and lays the groundwork of later self-regulation of emotions The childs needs for comfort and exploration encouragement shift rapidly and the caregiver must continuously adjust to those needs whenever possible
Meta-analytic evidence identifies short term group approaches 16 sessions targeting maternal sensitivity as being the most effective and sensitivity focused interventions conducted with referred at-risk samples eg DSM-III-R depressed mothers as being more effective than interventions with other groups Attachment security in particular has been found to be readily influenced by sensitivity-focused interventions The program Circle of Security Parenting COS-P is a recent and shorter version of COS that consists of eight weekly sessions of two hours durations without the individual video assessment of attachment In COS-P standard video materials of child attachment behaviors as well as the graphic materials to illustrate the Circle of Security are used Themes that are covered during the program are The Circle of Security Exploration of the childs needs in the circle Being with your child in the circle Exploration of own challenges in meeting childs needs and Disruption and repair of the relationship
To the best of the investigators knowledge the effectiveness of COS-P in relation to enhancing maternal sensitivity and the mother-infant relationship has not been fully tested in an RCT design in a general population making this study the first Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country Further COS-P is a promising approach as health nurses can be trained COS-P therapists in future up-scaling
There is by now solid evidence that the establishment of attachment relationships ie a stable emotional bond with a caregiver - mostly the parent - is one of the most important developmental milestones in infancy Early parent-child attachment relationships function as a blueprint for future social relationships and serve as a framework within which children learn how to deal with stressful situations and to regulate the accompanying negative emotions Insecure and disorganized attachment is a significant risk for longitudinal child development and psychopathology as the ability to regulate ones feelings of stress and negative emotions is important for a wide range of socio-emotional outcomes ranging from social competence moral development and empathy to academic achievement Recent meta-analyses show that insecure and disorganized children have a higher risk of developing mental problems later in life Insecurely attached children are also more likely than securely attached children to develop internalizing problems such as anxiety and depressive symptoms as well as externalizing problems such as aggressive behavior For externalizing problems the risk was even higher for disorganized children Furthermore research into early brain development indicates that brain development can be physiologically altered by severe stress imposed by neglect and inadequate parenting during a childs early years
Evidence from attachment research shows that sensitive parenting where the parent is alert and able to understand the infants expression of emotional states and able to manage and meet the infants needs contingently adequately and in a comforting way will lead to the establishment of a pattern of secure attachment in the child Lack of availability inconsistent availability misunderstanding of the infants emotional expression and parental behavior that frightens the infant may all lead to an insure attachment and in the most severe cases a disorganized attachment This is indicative of a breakdown of an organized secure or insecure attachment behavioral strategy Disorganized attachment is considered to be the result of parental behavior that is frightening for the child An extreme example of such behavior is child maltreatment but all sorts of parental behavior that are not comprehensible for the child such as dissociation which is common in depressed parents is potentially frightening for the child This sort of behavior results in the paradoxical situation that the parent is a source of comfort and a source of fear at the same time Thus in stress situations the child does not know what to do and the behavioral strategy collapses
Infant social withdrawal indicates infant distress and early attachment disturbances and is a known risk factor for infant mental health Infant social withdrawal is indicated by a lack of either positive eg smiling eye contact or negative vocal protestations Sustained withdrawal behavior in infants can be seen as a chronic diminution of the attachment system which is gradually generalized into a diminished engagement and lowered reactivity to the environment at large In more European countries the use of the validated systematic screening method Alarm Distress Baby Scale ADBB for identifying infant delayed socio-emotional development in infant mental health clinics and in home visiting programs have shown promising results
Postnatal depression PND is another known risk for infant mental health A meta-analysis shows that up to 19 of new mothers may experience minor or major depression during the first months postpartum If only including major depression the prevalence was found to be 71 In a more recent European study 1066 women were followed from pregnancy to 12 months postpartum The results indicated that 96 of new mothers may experience a major depressive episode during the first year after delivery No estimates were given for minor depression Most cases develop within the first three months with a peak incidence of about 4-6 weeks
PND has a substantial impact on the mother her partner her family mother-baby interactions and attachment insecurity and the longer term socio-emotional and cognitive development of the baby especially when depression occurs in the first year of life Often mothers suffering from postnatal depression are emotionally cognitively andor behaviorally inhibited or impaired in their ability to recognize and react with appropriate sensitivity and responsiveness to their childrens needs With regard to the infants of these mothers higher incidences of negative behaviors such as social withdrawal persistent crying averted gaze or head position physical neediness and a lack of expression of delight in the presence of their mothers have been observed These behaviors increase the mothers experience of stress which further contributes to the maintenance of maladaptive interactional behavioral patterns Without improvement in these negative interaction cycles for example through early interventions there is a greater likelihood for infants to develop an insecure-avoidant an insecure ambivalent or disorganized attachment pattern
Research on the treatment of women with postnatal depression has shown that treatment that only focuses on the mother ie medication psychotherapy is insufficient to buffer against the negative impact of maternal psychopathology on the childs cognitive and psychosocial development as well as infant-mother attachment quality Even when depression is effectively treated this does not seem to spill over and improve the mother-infant relationship and long-term infant social-emotional outcomes Instead it is necessary to support the depressed mothers in their specific needs in caring and relating to their infants
Interventions targeting PND delivered in groups have been found to achieve change through the dual process of emotional experience and reflection in an interpersonal context Group sessions provide a support network reduce isolation and stigma provide an environment in which to practice interpersonal and communication skills shape coping strategies and learn from each other and enable a number of families to be treated at once Recently building on evidence from attachment research a special focus is given to preventive group programs that enhance parental sensitivity and secure attachment such as the intervention program Circle of Security COS Based on findings from more studies COS has proved efficient in enhancing secure attachment as well as reducing maternal depressive symptomatology in high-risk samples including mothers in prison and mentally ill mothers The original COS program consists of 20 weekly sessions of 2 hour durations and includes an initial video assessment of parent -child attachment In the COS intervention graphical illustrations of the Circle of Security are used This Circle is a roadmap that encompasses the three basic control systems the attachment system the exploration system and the caregiving system The parent is illustrated through the pair of hands that hold together the childs world In COS concepts holding means to serve as a secure base and safe haven The top half of the Circle depicts the childs exploration system and needs I order to explore the child needs the parent to serve as a secure base by watching over delighting in helping and enjoying with the child Having a parent that supports exploration helps the child develop his or her own sense of interest leading to mastery and competency in later years Along the bottom half is the childs attachment needs protect me comfort me delight in me and organize my feelings By delighting in the child the parent helps the child constructing an internal representation of him- of herself as a loved person and thereby establish self-worth and by organizing the childs feelings by accepting sharing and naming them the parent co-regulates the childs emotions and lays the groundwork of later self-regulation of emotions The childs needs for comfort and exploration encouragement shift rapidly and the caregiver must continuously adjust to those needs whenever possible
Meta-analytic evidence identifies short term group approaches 16 sessions targeting maternal sensitivity as being the most effective and sensitivity focused interventions conducted with referred at-risk samples eg DSM-III-R depressed mothers as being more effective than interventions with other groups Attachment security in particular has been found to be readily influenced by sensitivity-focused interventions The program Circle of Security Parenting COS-P is a recent and shorter version of COS that consists of eight weekly sessions of two hours durations without the individual video assessment of attachment In COS-P standard video materials of child attachment behaviors as well as the graphic materials to illustrate the Circle of Security are used Themes that are covered during the program are The Circle of Security Exploration of the childs needs in the circle Being with your child in the circle Exploration of own challenges in meeting childs needs and Disruption and repair of the relationship
To the best of the investigators knowledge the effectiveness of COS-P in relation to enhancing maternal sensitivity and the mother-infant relationship has not been fully tested in an RCT design in a general population making this study the first Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country Further COS-P is a promising approach as health nurses can be trained COS-P therapists in future up-scaling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None