Cerebral Palsy - Early Diagnosis and Intervention Trial: protocol for the prospective multicentre CP-EDIT study with focus on diagnosis, prognostic factors, and intervention.

BACKGROUND: Early diagnosis of cerebral palsy (CP) is important to enable intervention at a time when neuroplasticity is at its highest. Current mean age at diagnosis is 13 months in Denmark. Recent research has documented that an early-diagnosis set-up can lower diagnostic age in high-risk infants. The aim of the current study is to lower diagnostic age of CP regardless of neonatal risk factors. Additionally, we want to investigate if an early intervention program added to standard care is superior to standard care alone. METHODS: The current multicentre study CP-EDIT (Early Diagnosis and Intervention Trial) with the GO-PLAY intervention included (Goal Oriented ParentaL supported home ActivitY program), aims at testing the feasibility of an early diagnosis set-up and the GO-PLAY early intervention. CP-EDIT is a prospective cohort study, consecutively assessing approximately 500 infants at risk of CP. We will systematically collect data at inclusion (age 3-11 months) and follow a subset of participants (n = 300) with CP or at high risk of CP until the age of two years. The GO-PLAY early intervention will be tested in 80 infants with CP or high risk of CP. Focus is on eight areas related to implementation and perspectives of the families: early cerebral magnetic resonance imaging (MRI), early genetic testing, implementation of the General Movements Assessment method, analysis of the GO-PLAY early intervention, parental perspective of early intervention and early diagnosis, early prediction of CP, and comparative analysis of the Hand Assessment for Infants, Hammersmith Infant Neurological Examination, MRI, and the General Movements method. DISCUSSION: Early screening for CP is increasingly possible and an interim diagnosis of "high risk of CP" is recommended but not currently used in clinical care in Denmark. Additionally, there is a need to accelerate identification in mild or ambiguous cases to facilitate appropriate therapy early. Most studies on early diagnosis focus on identifying CP in infants below five months corrected age. Little is known about early diagnosis in the 50% of all CP cases that are discernible later in infancy. The current study aims at improving care of patients with CP even before they have an established diagnosis. TRIAL REGISTRATION: ClinicalTrials.gov ID 22013292 (reg. date 31/MAR/2023) for the CP-EDIT cohort and ID 22041835 (reg. date 31/MAR/2023) for the GO-PLAY trial.

Antenatal caregiving representations and perinatal behavior in mothers with severe lifetime psychopathology.

Psychopathology poses a risk for optimal parenting. The current study explored antenatal caregiving representations as markers for later risk of nonoptimal maternal behavior among mothers with severe mental illness. Sixty-five mothers diagnosed with psychosis, bipolar disorder, depression (psychopathology group), and nonclinical controls participated in a longitudinal study from pregnancy to 16 weeks after birth. Mental health diagnoses and caregiving representations were assessed during pregnancy. Maternal behavior was assessed during the 5-min recovery phase of the still-face paradigm at 16 weeks. Mothers with psychopathology reported significantly higher levels of "heightened" caregiving representations (i.e., separation anxiety from the child) than did controls. The only significant diagnostic group difference in perinatal maternal behavior was that mothers diagnosed with depression exhibited more overriding-intrusive behavior than did nonclinical control mothers. Regression modeling results showed that antenatal caregiving representations of "role reversal" predicted significantly lower levels of sensitivity and higher levels of overriding-intrusive behavior independent of the effect of psychopathology. The findings can be interpreted in the context of representational transformation to motherhood during pregnancy. The results provide preliminary evidence for the potential of a new questionnaire measure of caregiving representations as a screening instrument for antenatal representational risk.

La sicopatología presenta un riesgo para la crianza óptima. El presente estudio exploró las representaciones antenatales de la prestación de cuidado como señales para un posterior riesgo de conducta materna no óptima entre madres con una enfermedad mental severa. Sesenta y cinco madres con diagnosis de sicosis, trastorno bipolar, depresión (grupo de sicopatología), así como madres en el grupo control no clínico participaron en un estudio longitudinal desde el embarazo hasta 16 semanas después del nacimiento. Se evaluaron los diagnósticos de salud mental y las representaciones de la prestación de cuidado durante el embarazo. La conducta materna fue evaluada durante la fase de cinco minutos de recuperación del paradigma de la Cara Inmóvil a las 16 semanas. Las madres con sicopatología reportaron niveles significativamente más altos de representaciones "agudizadas" de la prestación de cuidado (v.g. ansiedad de estar separadas de su niño) que las madres del grupo de control. La única significativa diferencia de grupo de diagnóstico en cuanto a la conducta materna perinatal fue que las madres con diagnosis de depresión presentaron una conducta predominantemente más intrusa que las madres del grupo de control no clínico. Los resultados del uso de modelos de regresión mostraron que las representaciones antenatales de la prestación de cuidado en cuanto al 'cambio de roles' predijeron niveles significativamente más bajos de sensibilidad y niveles más altos de conductas predominantemente intrusas, independiente del efecto de la sicopatología. Se pueden interpretar los resultados en el contexto de la transformación de representación hacia la maternidad durante el embarazo. Los resultados aportan evidencia preliminar para la posibilidad de una nueva medida de cuestionario sobre las representaciones de la prestación de cuidado como instrumento de detección del riesgo de la representación antenatal.

La psychopathologie pose un risque pour le parentage optimal. Cette étude a exploré les représentations de soin anténatal en tant que marqueurs de risque ultérieur de comportement maternel non-optimal chez les mères atteintes d'une maladie mentale sérieuse. Soixante-cinq mères ayant été diagnostiquées avec une psychose, un trouble maniaco-dépressif, une dépression (groupe psychopathologie) et des contrôles non-cliniques ont participé à une étude longitudinale de la grossesse à 16 semaines après la naissance. Les diagnostics de santé mentale et les représentations de soin ont été évaluées durant la grossesse. Le comportement maternel a été évalué durant la phase de récupération de cinq minutes du paradigme de Visage Immobile à 16 semaines. Les mères avec une psychopathologie ont fait état de niveaux bien plus élevés de représentations 'accrues' de soin (anxiété de séparation d'avec l'enfant) que les contrôles. La seule différence importante de diagnostic de groupe dans le comportement maternel périnatal était que les mères diagnostiquées avec une dépression ont fait preuve de plus de comportement prépondérant-intrusif que les mères du groupe de contrôle non-clinique. Les résultats du modèle de régression ont montré que les représentations anténatales de soin de 'l'inversion des rôles' ont prédit des niveaux de sensibilité bien plus bas et des niveaux de comportement prépondérant-intrusif bien plus élevés quel que soit l'effet de la psychopathologie. Les résultats peuvent être interprétés dans le contexte de la transformation représentationnelle de la maternité durant la grossesse. Les résultats offrent des preuves préliminaires quant au potentiel d'un nouveau questionnaire comme mesure de représentations de soin en tant qu'instrument de dépistage du risque représentationnel anténatal.

Antenatal caregiving representations among expectant mothers with severe mental illness: a cross-sectional study.

Objective: The study explores predictors of antenatal caregiving representations among mothers with a history of severe mental illness (SMI). Background: Attachment research has demonstrated that multifactorial assessment of antenatal caregiving representations predicts later maternal behaviour and child attachment. However, the field lacks research among clinical groups. Knowledge of factors influencing caregiving representations during pregnancy can contribute to our understanding of caregiving risk among SMI-mothers and inform intervention decisions. Method: The current study is a cross-sectional subsample of the WARM study. Participants were 65 Danish or Scottish pregnant women with a history of either schizophrenia, bipolar disorder, moderate-severe depression, or non-clinical controls. Caregiving representations, adverse childhood experiences, social support and current symptom severity were assessed during pregnancy. Results: Symptom severity was associated with more non-optimal caregiving representations expecting less parental enjoyment, more difficulties separating from the child, and more feelings of caregiving helplessness. Lack of social support and adverse childhood experiences served as independent predictors of caregiving representations. Parental mental illness during own childhood predicted role reversed expectations. Conclusion: Antenatal caregiving representations can be assessed with a time-efficient self-report measure that assesses caregiving as a multidimensional construct. Prenatal treatment planning should target individual difficulties in undertaking transformation of the caregiving system.

Wellbeing and resilience: mechanisms of transmission of health and risk in parents with complex mental health problems and their offspring--The WARM Study.

UNLABELLED: The WARM study is a longitudinal cohort study following infants of mothers with schizophrenia, bipolar disorder, depression and control from pregnancy to infant 1 year of age. BACKGROUND: Children of parents diagnosed with complex mental health problems including schizophrenia, bipolar disorder and depression, are at increased risk of developing mental health problems compared to the general population. Little is known regarding the early developmental trajectories of infants who are at ultra-high risk and in particular the balance of risk and protective factors expressed in the quality of early caregiver-interaction. METHODS/DESIGN: We are establishing a cohort of pregnant women with a lifetime diagnosis of schizophrenia, bipolar disorder, major depressive disorder and a non-psychiatric control group. Factors in the parents, the infant and the social environment will be evaluated at 1, 4, 16 and 52 weeks in terms of evolution of very early indicators of developmental risk and resilience focusing on three possible environmental transmission mechanisms: stress, maternal caregiver representation, and caregiver-infant interaction. DISCUSSION: The study will provide data on very early risk developmental status and associated psychosocial risk factors, which will be important for developing targeted preventive interventions for infants of parents with severe mental disorder. TRIAL REGISTRATION: NCT02306551, date of registration November 12, 2014.

A randomized trial of the Caregiver Interaction Profile (CIP) training with childcare providers: the Copenhagen Daycare Project study protocol.

BACKGROUND: Most young children (0-3 years) attend formal childcare in Denmark, many of them fulltime. Yet recent reports of the quality of Danish childcare centers have shown that in more than one-third of nurseries, the interactions between caregivers and young children (0-3 years) are of "insufficient" quality, which constitutes a risk for affected children's well-being and development. Effective interventions to improve childcare providers' interactive skills are necessary. METHODS: In this randomized controlled trial, we test the effectiveness of the Caregiver Interaction Profile training, which focuses on improving six core interactive skills: sensitive responsiveness, respecting children's autonomy, structuring and limit setting, verbal communication, developmental stimulation, and fostering positive peer interactions. We will recruit N = 200 childcare providers from nursery groups in Copenhagen (n = 100 training group, n = 100 waiting-list control group). Our primary outcomes are childcare providers' six interactive skills named above, observed from video-recorded interactions in the nursery groups. The secondary goal of our study is to test whether the training boosts children's social-emotional and linguistic development. To this end we aim to recruit N ≈ 500 children from participating childcare providers' nursery groups (n ≈ 250 training group, n ≈ 250 waiting-list control group). We measure social-emotional and linguistic development with various standardized questionnaires, filled out by parents and childcare providers. DISCUSSION: If the training is effective at improving childcare providers' interactive skills, then this will be an important foundation for implementation efforts, such as offering the training as part of the educational program of childcare providers. Future research should also evaluate whether the Caregiver Interaction Profile training is effective for childcare providers of older children (3-5 years) in Danish kindergartens. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov as "Testing the Effects of the Caregiver Interaction Profile Training on the Interactive Skills of Daycare Providers (CDP)" with registry ID NCT05654116. Registration date: 12/01/2022.

Combining the Antenatal Risk Questionnaire and the Edinburgh Postnatal Depression Scale in Early Pregnancy in Danish Antenatal Care-A Qualitative Descriptive Study.

Pregnant women with a history of mental disorders, neglect, or low social support are at increased risk of mental health problems. It is crucial to identify psychosocial risk factors in early pregnancy to reduce the risk of short- and long-term health consequences for mother and child. The Antenatal Risk Questionnaire has been found acceptable as a psychosocial screening tool among pregnant women in Australia, but it has not been tested in a Scandinavian context. The aim of this study was to explore the experiences of pregnant women when using the Antenatal Risk Questionnaire and the Edinburgh Postnatal Depression Scale as part of a model to identify psychosocial vulnerabilities in pregnancy in Denmark. We conducted individual interviews (n = 18) and used thematic analysis. We identified two main themes: (1) Feeling heard and (2) An occasion for self-reflection. Overall, the pregnant women deemed the online ANRQ/EPDS acceptable as a screening tool. The screening model provided a feeling of being heard and provided an occasion for self-reflection about mental health challenges related to pregnancy and motherhood. However, some women expressed that the screening raised concerns and fear of the consequences of answering honestly. A non-judgmental, open, emphatic, and reassuring approach by clinicians may help reduce stigma.

The Feasibility of the Adverse Childhood Experiences Questionnaire among Women in Danish Antenatal Care: A Mixed-Methods Study.

A traumatic upbringing increases the risks of antenatal health problems, unfavourable pregnancy outcomes, and mental disorders. Such childhood experiences may affect women's pa-renting skills and the social-emotional functioning of their children. Research on screening for adverse childhood experiences in antenatal care is limited. The objective of this study was to explore pregnant women's attitudes towards and experiences of an adverse childhood experiences questionnaire, and to assess the relevance of the questionnaire among a population of pregnant women referred to antenatal care levels one and two, targeting women who are generally not perceived to be vulnerable. Data were collected at three maternity wards and consisted of quantitative data on 1352 women's adverse childhood experience scores, structured observations of 18 midwifery visits, and in-depth interviews with 15 pregnant women. Quantitative data were analysed by descriptive statistics, and qualitative data were analysed using systematic text condensation. The qualitative analysis revealed two main categories: "Being screened for childhood adversities" and "Having adverse childhood experiences". In the study population, the prevalence of adverse childhood experiences was high. The women assessed the adverse childhood experiences questionnaire to be a relevant and acceptable screening method. Furthermore, women's perceptions of their relationship with their midwife greatly impacted their attitudes towards and experiences of the questionnaire.

The Feasibility and Acceptability of the Adverse Childhood Experiences Questionnaire in Danish Antenatal Care-A Qualitative Study of Midwives' Implementation Experiences.

Adverse childhood experiences have a potential lifelong impact on health. A traumatic upbringing may increase antenatal health risks in mothers-to-be and impact child development in their offspring. Yet, little is known about the identification of adverse childhood experiences in antenatal care. The objective of this study was to explore the feasibility and acceptability of the adverse childhood experiences questionnaire among midwives and factors affecting its implementation. Three Danish maternity wards participated in the study. The data consisted of observations of midwifery visits and informal conversations with midwives, as well as mini group interviews and dialogue meetings with midwives. The data were analysed using systematic text condensation. Analysis of the data revealed three main categories; "Relevance of the adverse childhood experiences questionnaire", "Challenges related to use of the adverse childhood experiences questionnaire" and "Apprehensions, emotional strain, and professional support". The findings showed that the adverse childhood experiences questionnaire was feasible to implement in Danish antenatal care. Midwives' acceptability of the questionnaire was high. Training courses and dialogue meetings motivated the midwives to work with the questionnaire in practice. The main factors affecting the implementation process were time restrictions, worries of overstepping women's boundaries, and a lack of a specific intervention for women affected by their traumatic upbringing circumstances.

Efficacy of a randomized controlled trial of a perinatal adaptation of COS-P in promoting maternal sensitivity and mental wellbeing among women with psychosocial vulnerabilities.

Pregnant women with psychosocial vulnerabilities should be offered perinatal interventions that include a parenting component to ameliorate the potential negative effects of maternal mental health problems and/or poor social network on parenting. One such intervention program is the Circle of Security-Parenting intervention (COS-P). The COS-P is a manualized video-based intervention that based on attachment theory seek to enhance maternal sensitivity and decrease the risk on insecure and disorganized attachment. We carried out a randomized controlled trial examining the efficacy of a perinatal adapted version of COS-P for women with psychosocial vulnerabilities (e.g. histories of mental health problems and/or poor social networks). Eligible participants (N = 78) were recruited to the study by midwives during regular prenatal sessions. Interventions were delivered individually at home by trained health nurses both pre and post birth. The primary outcome was maternal sensitivity assessed with the Coding Interactive Behavior Manual by blinded coders from video-recordings of mother-infant free play interactions. Secondary outcomes were mother-reported depressive symptoms, parental reflective functioning, parental stress, infant socio-emotional functioning, and maternal wellbeing. All outcomes were assessed at nine months infant age. We did not find an effect of the intervention on the primary outcome of maternal sensitivity (ß = -0.08; 95% CI [-0.41, 0.26], p = .66). Neither did we find intervention effects on the secondary outcomes of depressive symptoms, parental reflective functioning, maternal well-being, or infant socio-emotional functioning. We did however find that the intervention decreased parental stress (ß = -8.51; 95% CI [-16.6;-0.41], p = .04). The results are discussed in light of existing findings on the effect of COS-P and sample heterogeneity. Furthermore, we discuss the challenges of adapting the COS-P for pregnant women, some without prior experiences with caregiving. Future research with larger at-risk samples examining moderation factors (e.g. adult attachment, depression maternal-fetal attachment) are recommended.

Parent-Infant Interactions Among Infants With High Risk of Cerebral Palsy: A Protocol for an Observational Study of Infant and Parental Factors for Dyadic Reciprocity.

Background: An early diagnosis of chronic disability, such as risk of Cerebral Palsy (CP), is likely to affect the quality of parent-infant interactions by affecting both infant and parental factors. Due to adverse perinatal events, infants at high risk of CP may exhibit less engagement in interactions, while parents may experience increased mental health problems and disrupted parental representations that can have a negative effect on parental sensitivity. Recent clinical guidelines on early intervention among families with infants at risk of CP recommends supporting parental sensitivity and mutual enjoyable interactions more research is needed to inform such interventions. This includes understanding how infant and parental risk as well as resilience factors impact parent-infant interactions and how existing parenting programs developed among typical developing infants should be adapted to families with infants at risk of CP. In addition, as majority of research on infant neurohabilitation focus on improving motor and cognitive outcomes research on infant emotional development is needed. The study aim is to assess the quality of early parent-infant interactions in families with high-risk infants, compared to families with low-risk infants, and to explore how interaction quality is affected by infant and parental factors. Three potential mediating factors explaining the association between CP risk and less optimal parent-infant interactions will be explored: infant interactional capacities, parental mental health and well-being, and parents' representations of their child. Methods: The prospective, longitudinal design will follow infants at high risk for CP and their parents and a control group at three time points from 15 weeks to 15 months corrected infant age (CA). Measures comprise infant developmental assessments, questionnaires and interviews with both parents, and global ratings of video-recorded parent-infant interactions. Discussion: Study results will enhance our understanding of how parent-infant interactions may be affected by perinatal neurological risk and identify potential important mechanisms for observed associations. This knowledge could assist in planning future early screening and intervention programs and identifying families who should be offered targeted psychological interventions in addition to neurohabilitation programs.

COpenhagen Neuroplastic TRaining Against Contractures in Toddlers (CONTRACT): protocol of an open-label randomised clinical trial with blinded assessment for prevention of contractures in infants with high risk of cerebral palsy.

INTRODUCTION: Contractures are frequent causes of reduced mobility in children with cerebral palsy (CP) already at the age of 2-3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that effective early prevention may have to involve stimuli that can facilitate muscle growth before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early multicomponent intervention, CONTRACT, involving family-oriented and supervised home-based training, diet and electrical muscle stimulation directed at facilitating muscle growth and thus reduce the risk of contractures in children at high risk of CP compared with standard care. METHODS AND ANALYSIS: A two-group, parallel, open-label randomised clinical trial with blinded assessment (n=50) will be conducted. Infants diagnosed with CP or designated at high risk of CP based on abnormal neuroimaging or absent fidgety movement determined as part of General Movement Assessment, age 9-17 weeks corrected age (CA) will be recruited. A balanced 1:1 randomisation will be made by a computer. The intervention will last for 6 months aiming to support parents in providing daily individualised, goal-directed activities and primarily in lower legs that may stimulate their child to move more and increase muscle growth. Guidance and education of the parents regarding the nutritional benefits of docosahexaenic acid (DHA) and vitamin D for the developing brain and muscle growth will be provided. Infants will receive DHA drops as nutritional supplements and neuromuscular stimulation to facilitate muscle growth. The control group will receive standard care as offered by their local hospital or community. Outcome measures will be taken at 9, 12, 18, 24, 36 and 48 months CA. Primary and secondary outcome measure will be lower leg muscle volume and stiffness of the triceps surae musculotendinous unit together with infant motor profile, respectively. ETHICS AND DISSEMINATION: Full approval from the local ethics committee, Danish Committee System on Health Research Ethics, Region H (H-19041562). Experimental procedures conform with the Declaration of Helsinki. TRIAL REGISTRATION NUMBER: NCT04250454. EXPECTED RECRUITMENT PERIOD: 1 January 2021-1 January 2025.

An early intervention to promote maternal sensitivity in the perinatal period for women with psychosocial vulnerabilities: study protocol of a randomized controlled trial.

BACKGROUND: Maternal mental well-being and social circumstances during pregnancy and early childhood impact the child's well-being and development. Supportive and sensitive parenting is one of the strongest predictors of positive emotional, social and behavioral outcomes for the child. Knowledge is needed about how to detect and support vulnerable families already during pregnancy and in the postnatal period. The aim of this study is to assemble and evaluate an interdisciplinary cross-sectoral intervention to promote maternal sensitivity among women with psychological or social vulnerabilities. METHODS/DESIGN: This randomized controlled trial tests the efficacy of an intervention program in the perinatal period compared to care as usual in enhancing maternal sensitivity in a group of psychologically or socially vulnerable women in the Capital Region of Denmark. The intervention consists of four components: 1) detecting symptoms of mental illness in vulnerable pregnant women and initiating treatment if indicated, 2) strengthening parenting skills using the Circle of Security Parenting program, 3) supporting breastfeeding, and 4) sharing knowledge and organizing treatment pathways for families across sectors. Seventy-six families will be randomly assigned to the intervention or care-as-usual. Data will be obtained at study inclusion at 3-5 months of pregnancy, eight weeks after childbirth, and nine months after childbirth. The primary outcome is maternal sensitivity. Secondary outcomes include infant's socio-emotional development, parents' mentalization, parental stress, depressive symptoms, and parental wellbeing. Qualitative data will provide insight into the implementation process. DISCUSSION: This paper presents the rational and background for developing the intervention. Furthermore, the design and protocol of the randomized controlled trial. It is hypothesized that the intervention will be associated with positive changes in primary and secondary outcomes. If effective, the intervention will provide insights into prenatal risk profiles among an identified group of psychosocial vulnerable women important for early screening and point to effective preventive interventions that can support women in the perinatal period, increase maternal sensitivity and promote positive child development -starting before the child is born. TRIAL REGISTRATION: ClinicalTrials.gov: ID: NCT03190707. Registered June 16, 2017.

Maternal-fetal bonding among pregnant women at psychosocial risk: The roles of adult attachment style, prenatal parental reflective functioning, and depressive symptoms.

Pregnancy offers a unique period for initiating preventive parenting interventions. Disturbances in maternal-fetal bonding may indicate suboptimal parenting and a need for intervention. However, more knowledge is needed on the development of maternal-fetal bonding among at-risk groups. The study aim was to examine psychosocial correlates of maternal-fetal bonding among pregnant women identified to be at risk socially and regarding their mental health. The sample consisted of 78 at-risk pregnant women participating in a perinatal intervention study: Godt på Vej Sammen [A Good Start to Life-an Early Cross-sectorial Intervention]. This study was cross-sectional reporting on the baseline characteristics of the participants. In the beginning of the second trimester, participants completed questionnaires assessing maternal-fetal bonding (the Maternal Antenatal Attachment Scale [MAAS]), prenatal parental reflective functioning, adult attachment style, and depressive symptoms. We compared the distribution of MAAS styles with norms from a recent Dutch community sample. In addition, we tested associations between psychosocial variables and the quality and intensity of MAAS scores in regression models and performed Chi-square analyses to assess the association of MAAS styles with psychosocial variables. First, compared to women from a community sample, approximately half of the women in our sample presented lower and suboptimal MAAS scores. Second, insecure avoidant adult attachment style was negatively associated with MAAS intensity, and depressive symptoms were negatively associated with MAAS quality. Third, prenatal parental reflective functioning positively correlated with both quality and intensity of MAAS. Fourth, we found no association between insecure anxious adult attachment style and MAAS scores. Fifth, women with a negative disinterested MAAS style demonstrated the highest avoidant attachment scores, while women with a positively preoccupied MAAS style demonstrated the highest prenatal parental reflective functioning scores. The results suggest that there is a need to differentiate among at-risk pregnant woman and that prenatal screening using the MAAS may help identify those who need preventive parenting interventions and what those interventions should focus on. A main limitation of the study is the lack of a representative group of at-risk pregnant women which limits the generalizability of the study results to all risk groups.