Family Partner: study protocol for a pilot randomised study of a home-visitation intervention in Norway.

AIM: Every year, about 5% of children in Norway experience severe child maltreatment and need support from the child welfare services. However, research-supported interventions for this group are lacking. The current study piloted an intensive home-visitation intervention, Family Partner, which aims to reduce child maltreatment among at-risk parents by improving parental skills, agency and trust in the welfare services, and children's well-being. The randomised controlled trial piloted in this study examines the acceptability of the Family Partner intervention for staff and families and evaluates its feasibility for a full-scale randomised controlled trial. METHODS: This protocol outlines a prospective, parallel, pilot randomised trial of the Family Partner intervention in three Norwegian municipal child welfare services. The participants are families with children under 12 years of age, where the parents are identified as having challenges. Families in the treatment group receive the Family Partner intervention, while families in the control group receive ordinary child welfare services. Data are collected at baseline, and at 3, 6, 12 and 18 months after recruitment. The pilot study monitor retention and adherence to inform the feasibility of a future full-scale randomised study. To assess the acceptability of the trial and intervention, a subsample of the participating families, as well as the family partners and representatives of the child welfare services in each municipality, are invited to complete qualitative interviews. CONCLUSIONS: The results will guide the design of a fully powered randomised controlled trial of the Family Partner intervention compared with ordinary child welfare services. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04957394; Pilot Trial of Family Partner: a Child Maltreatment Prevention Intervention (FAMPART); registered on 12 July 2021.

The Infant Health Study - Promoting mental health and healthy weight through sensitive parenting to infants with cognitive, emotional, and regulatory vulnerabilities: protocol for a stepped-wedge cluster-randomized trial and a process evaluation within municipality settings.

BACKGROUND: Child mental health problems are a major public health concern associated with poor mental and physical health later in development. The study evaluates a new community-based intervention to promote sensitive parenting and reduce enduring mental health problems and unhealthy weight among vulnerable infants aged 9-24 months. METHODS: We use a step-wedge cluster randomized controlled trial design conducted within a home visiting program offered by community health nurses to infant families in Denmark. Sixteen municipalities are randomly allocated to implement the intervention starting at three successive time points from May 1, 2022 to January 1, 2023. A total of 900-1000 families will be included. A standardized program, Psykisk Udvikling og Funktion (PUF), is used to identify infants with major problems of eating, sleep, emotional or behavioral regulation or developmental problems. The intervention builds on the Video-Feedback Intervention to Promote Positive Parenting (VIPP) program, adapted to the PUF-context and named the VIPP-PUF. Children will be followed up at ages 18 and 24 months. Primary outcome measure is the Strengths and Difficulties Questionnaire (SDQ) at child age 24 months. The other outcome measures include body mass index z-scores, the Ages and Stages Questionnaire Social-Emotional (ASQ:SE2); the Child Behavior Checklist (CBCL 1½ -5); Eating behavior Questionnaires; the Being a Mother-questionnaire (BaM13); the Parental Stress Scale (PSS); and the WHO-5 well-being index (WHO-5). Data on child and family factors are obtained from National registries and the Child Health Database. Quantitative measures are applied to examine the effectiveness of the VIPP-PUF intervention and the implementation process. Qualitative measures include interviews with CHNs, parents and municipality stakeholders to explore factors that may influence the adherence and effectiveness of the intervention. DISCUSSION: The study examines a service-setting based intervention building on the promotion of sensitive parenting to vulnerable infants. We use a mixed methods approach to evaluate the intervention, taking into account the influences of COVID-19 pandemic running since March 2020. Overall, the study has potential to add to the knowledge on the possibilities of prevention within the municipality child health care to reduce the risk of mental health problems and unhealthy weight in early childhood. TRIAL REGISTRATION: www.ClinicalTrials.gov ; ID NCT04601779 ; Protocol ID 95-110-21307. Registered 25 June 2021.

The Parental Stress Scale revisited: Rasch-based construct validity for Danish parents of children 2-18 years old with and without behavioral problems.

BACKGROUND: Experiencing parental stress is common among parents of children of all ages and is elevated in families characterized by stressors such as poverty, mental health problems, and developmental problems. The Parental Stress Scale (PSS) is a short measure for the assessment of perceived stress resulting from being a parent. METHODS: This study examines the construct validity and psychometric properties of the Danish PSS using Rasch and graphical loglinear Rasch models in a sample of parents of 2-18-year-old children with and without known behavior problems. We emphasized analyses of differential item functioning, to ascertain whether the scale yields unbiased scores for subgroups of parents. RESULTS: The 18-item PSS did not fit the Rasch model or a graphical loglinear Rasch model. After dichotomizing item responses and eliminating items 2 and 11, we found the PSS to consist of two distinct subscales measuring parental stress and lack of parental satisfaction. For the total sample, the Parental Stress subscale fit a very complex graphical loglinear Rasch model with differential item functioning relative to parental education and whether children had behavior problems or not. The Lack of Parental Satisfaction subscale fit a simple graphical loglinear Rasch model with differential item functioning only relative to subsample. When dividing into subsamples of parents of children with and without behavior problems, the Parental Stress subscale fit a simple graphical loglinear Rasch model, though still with differential item functioning, while the Lack of Parental Satisfaction subscale fit the Rasch model in each subsample of parents. Both subscales performed best for parents of children with behavior problems. CONCLUSIONS: The PSS should be used in a 16-item version and scored as two subscales. The PSS appears better suited for use among parents of children with behavior problems than within a sample without any known difficulties.

Parent Management Training Oregon Model and Family-Based Services as Usual for Behavioral Problems in Youth: A National Randomized Controlled Trial in Denmark.

This randomized control trial used intent-to-treat analyses to compare parent management training-Oregon model (PMTO) (N = 64) to family-based services as usual (SAU) (N = 62) in 3.5-13-year-old children and their families in Denmark. Outcomes were parent report of child internalizing and externalizing problems, parenting efficacy, parenting stress, parent sense of coherence, parent-report of life satisfaction, and parental depressive symptoms. Outcomes were measured at pretreatment, post-treatment, and 18-20 months post-treatment. Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion. Effect sizes at post-treatment and follow-up were in the small to moderate range, consistent with prior PMTO evaluations. However, there were no significant differences between PMTO and family-based SAU. Further research on the process and content of family-based SAU is needed to determine how this approach overlaps with and is distinct from PMTO.

Parent report measures of infant and toddler social-emotional development: a systematic review.

Background: Identifying young children at risk for socio-emotional developmental problems at an early stage, to prevent serious problems later in life, is crucial. Therefore, we need high quality measures to identify those children at risk for social-emotional problems who require further evaluation and intervention. Objective: To systematically identify parent report measures of infant and toddler (0-24 months) social-emotional development for use in primary care settings. Methods: We conducted a systematic review applying a narrative synthesis approach. We searched Medline, PsychInfo, Embase and SocIndex for articles published from 2008 through September 2015 to identify parent-report measures of infant and toddler social-emotional development. Data on the characteristics of the measures, including psychometric data, were collected. Results: Based on 3310 screened articles, we located 242 measures that were screened for eligibility. In all 18 measures of infant and toddler social-emotional development were included. Ten of the measures were developed specifically for measuring social-emotional development, and eight were measures including subscales of social-emotional development. The measures varied with respect to, e.g. the time of publication, number of items, age span, cost and amount of psychometric data available. Conclusions: Several measures of infant and toddler social-emotional development have been developed within the last decade. The majority of psychometric data are available through manuals, not peer-reviewed journals. Although all measures show acceptable reliability, the most comprehensive and psychometrically sound measures are the Ages and Stages Questionnaires: Social-Emotional-2, Infant-Toddler Social and Emotional Assessment, Brief Infant-Toddler Social and Emotional Assessment and Child Behaviour Checklist 1½-5.

Family Club Denmark: A Quasi-Randomized Study of a Volunteer-Based Intervention to Support Vulnerable Families.

Volunteer interventions play a vital role in supporting families by offering accessible and community-based resources outside the formal professional sector. This study examines the impact of the volunteer intervention known as Family Club Denmark (FCD) on the well-being of parents and children. FCD aims to provide families with positive experiences and support relationship building. The intervention, open to families from diverse social backgrounds, comprises volunteer-led family clubs where parents and children aged 2-12 years engage in activities and meals. We allocated 510 families (363 vulnerable families) to FCD or placed them on a waiting list based on a first-come, first-served principle. We conducted baseline, post-intervention, and follow-up assessments through questionnaires, observations, and interviews. On average, families participated in 5.8 sessions, with both families and volunteers reporting high satisfaction. When compared to control families, we find that vulnerable FCD parents feel more confident playing with their children (p = 0.04, [0.01; 0.40], d = 0.25), require less assistance in playing with their children (p = 0.01, [-0.34; -0.05], d = 0.33), and report that their children have a more challenging time forming friendships (p = 0.01, [-0.51; -0.09], d = 0.29). However, we did not find significant effects on mental health, parenting stress, self-efficacy, self-worth, family routines, or child well-being. We observed similar results for the full sample. The discovery that parents feel more confident playing with their children after participating in FCD highlights the vital role of volunteer-based interventions in enhancing parental engagement and fostering positive parent-child interactions. Trial registration: ClinicalTrials.gov NCT03657888 (registered 29 August 2018).

Care professionals' experiences within a multidisciplinary and cross-sectorial intervention for childbearing women and families in vulnerable positions: a focus group study.

PURPOSE: The aim of this study was to gain a deeper understanding of the experiences and perspectives of care professionals in multidisciplinary and cross-sectorial collaboration, and their experiences of interactions with childbearing families within the context of the FACAM project. METHODS: Eight focus groups were conducted with 32 multidisciplinary care professionals working with childbearing families in vulnerable positions. A thematic analysis was conducted, with positioning theory as the theoretical framework focusing on storylines, positioning and speech-acts. RESULTS: Two overall themes were constructed. Theme one: Cross-sectorial collaboration and the influence on the care provided. Theme two: Interaction with and assessment of women and families' care needs and their influence on the care provided, with three subthemes; a) Establishment of a trustful relationship, b) Assessments of vulnerable positions in relation to function in everyday life, c) Interactions with the woman or family depending on their needs. CONCLUSION: Care professionals found needs-adapted and tailored care meaningful. Well-functioning multidisciplinary and cross-sectorial collaboration was important to support the families.

Effects on Child Development and Parent-Child Interaction of the FACAM Intervention: A Randomized Controlled Study of an Interdisciplinary Intervention to Support Women in Vulnerable Positions through Pregnancy and Early Motherhood.

Health inequality can have a profound impact on a child's life. Maternal mental health challenges can hinder bonding, leading to impaired functioning and poorer child outcomes. To provide extra support for vulnerable pregnant women, the FACAM intervention offers the services of a health nurse or family therapist from pregnancy until the child starts school. This study examined the effects of FACAM intervention on pregnant women in vulnerable positions and their children until the child turned two years old. We randomly assigned 331 pregnant women to either FACAM intervention or care as usual and assessed them at baseline and when the infant was 3-6, 12-13.5, and 24 months old. The primary outcome was maternal sensitivity measured by Coding Interactive Behavior (CIB). Secondary outcomes included the parent-child relationship, child social-emotional development, child developmental progress, parent-child interaction, and child development. Our findings indicate that care-as-usual children were significantly more involved than FACAM children when the child was 4-6 months old (b = -0.25, [-0.42; -0.08] d = -0.42). However, we suspect this result is due to a biased dropout. We did not find any significant differences in any other outcomes. Therefore, the study suggests that the FACAM intervention is not superior to care as usual regarding child development and parent-child interaction outcomes.

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.

Measuring child and adolescent well-being in Denmark: Validation and norming of the Danish KIDSCREEN-10 child/adolescent version in a national representative sample of school pupils in grades five through eight.

KIDSCREEN-10 is a generic instrument for measuring global health-related quality of life among 8-18-year-old children and adolescents. This study examines the criterion-related construct validity and psychometric properties of the Danish language version of the KIDSCREEN-10 using Rasch models. A further aim was to construct Danish norms based on the resulting person parameter estimates from the Rasch models. Data consists of a nationally representative cross-sectional survey of 8171 children in the 5th to 8th grade of primary school in Denmark. No adequate fit to the Rasch model or a graphical loglinear Rasch model could be established for the KIDSCREEN-10 in the full sample of children (n = 8171). Results based on analyses with increasing samples sizes showed that even with the smallest sample item 3 (Kid3) of the KIDSCREEN-10 did not fit the Rasch model. After elimination of Kid3, substantial local dependence and differential item functioning relative to gender and grade level was still present. Already with a sample size of 630 fit to the Rasch model or a graphical loglinear Rasch model adjusting for local dependence and differential item functioning was not established. Therefore, generation of Danish norms was not realizable, as this requires valid sum scores and estimates of the person parameters for an adequate number of cases. Thus, the Danish language version of the child/adolescent self-report KIDSCREEN-10 questionnaire cannot be recommended for use in population-level studies. Neither can use in small sample be recommended as adjustment for differential item functioning and local dependence is ambiguous.

Holding a foster child's mind in mind: study protocol for a cluster-randomized controlled trial of mentalization-based therapy (MBT) for foster families.

BACKGROUND: Children in foster care are psychologically vulnerable and show more social, developmental, and behavioral problems than those living with their family of origin. Many foster parents struggle to care for these children, some of whom have experienced severe adversity. Research and theory suggest that developing a strong and supportive foster parent-child relationship is essential for foster children to become more well-adjusted and experience a decrease in behavioral problems and emotional maladjustment. Mentalization-based therapy (MBT) for foster families aims at increasing the reflective functioning of the foster parents, thus promoting the development of more secure and less disorganized child attachment representations, which is subsequently proposed as a factor that reduces behavioral problems and emotional maladjustment in children and promotes their overall well-being. METHODS: This is a prospective cluster-randomized controlled trial with two conditions: (1) the intervention group participating in MBT, and (2) the control group who receive usual care. Participants are 175 foster families with at least one foster child aged 4-17 years with emotional or behavioral problems. The intervention will be offered to foster families by 46 foster care consultants from 10 municipalities in Denmark. The foster care consultants will be randomized to MBT training (n = 23) or usual care (n = 23). The primary outcome is the psychosocial adjustment of the foster child measured by the Child Behavior Checklist (CBCL) as reported by foster parents. Secondary outcomes include child well-being, parental stress, parent mental health, parent reflective function and mind-mindedness, parent/child relations, child attachment representations, and placement breakdown. In order to explore implementation fidelity as well as practitioner experiences, we will administer questionnaires designed for this study and conduct qualitative research exploring the practice of the MBT therapists. DISCUSSION: This trial is the first experimental study of a family therapeutic intervention based on attachment theory for foster families within the Scandinavian context. This project will contribute with novel knowledge on attachment representations in foster children and the effects of an attachment-based intervention on essential outcomes for foster families and children. Trial registration ClinicalTrials.gov NCT05196724. Registered on January 19, 2022.

Parent-child Relationship Outcomes of the Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial.

Background: A warm, sensitive, and responsive relationship to a caregiver is essential for healthy child development. Objective: This paper examines the effects of the Incredible Years Parents and Babies (IYPB) program on the parent-child relationship at post-intervention when offered as a universal parenting intervention to parents with newborn infants. Method: We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to IYPB intervention (76) or usual care (36). The IYPB program is a group intervention with eight two-hour sessions. In addition to parent-reported questionnaires, we collected a six-minute-long video at post-intervention from 97 families to assess the parent-child relationship, which was then coded with the Coding Interactive Behavior system. Results: There were no significant intervention effects on either the total score or any of the seven subscales at post-intervention when the children were around 5.5 months old. For parental sensitivity, results were significant at the 10% level, favoring the IYPB group. When examining the lowest-functioning mothers in moderator analyses, we also found no significant differences between the two groups. Conclusion: In line with parent-report outcomes, we did not find any statistically significant differences between the IYPB program and usual care on parent-child relationship when offered as a universal intervention for a relatively well-functioning group of parents with infants in a setting with a high standard of usual care. However, there was a positive trend for the total score, parental sensitivity and reciprocity with effect sizes in the range of .41-.51. It is possible that a larger sample would have resulted in significant differences for these outcomes. Trial registration: ClinicalTrials.gov NCT01931917 (registration date August 27, 2013).

Parenting interventions to support parent/child attachment and psychosocial adjustment in foster and adoptive parents and children: A systematic review.

Background: Adopted children and children placed in foster care are at increased risk of developing a range of mental health, behavioural, and psychosocial adjustment problems. Previous studies suggest that due to early experiences of separation and loss some children may have difficulties forming a secure attachment relationship with the adoptive/foster parents. Objectives: The objectives of the present review were: (1) to assess the efficacy of attachment-based interventions on measures of favourable parent/child outcomes (attachment security, dyadic interaction, parent/child psychosocial adjustment, behavioural and mental health problems, and placement breakdown) within foster and adoptive families with children aged between 0 and 17 years. (2) to identify factors that appear to be associated with more effective outcomes and factors that modify intervention effectiveness (e.g., age of the child at placement and at intervention start, programme duration, programme focus). Search Methods: Relevant studies were identified through electronic searches of bibliographic databases, governmental and grey literature repositories, hand search in specific targeted journals, citation tracking, contact to international experts and Internet search engines. The database searches were carried out to October 2020. Selection Criteria: The interventions of interest were parenting interventions aimed at helping the foster/adopted children and their parents to form or sustain a secure attachment relationship. The interventions had to be at least partly informed by attachment theory. Data Collection and Analysis: The total number of potentially relevant studies constituted 17.822 hits after duplicates were removed. A total of 44 studies (27 different populations) met the inclusion criteria and were critically appraised by the review authors. Due to critical study quality, missing numeric data and re-use of the same data, only 24 studies analysing 16 different populations could be used in the data synthesis (children, N = 1302; parents, N = 1344). Meta-analysis using both child and parent outcomes were conducted on each metric separately. All analyses were inverse variance weighted using random effects statistical models. Random effects weighted mean effect sizes were calculated using 95% confidence intervals (CIs). When possible, we conducted moderator analysis using meta-regression and single factor sub group moderator analysis. Sensitivity analysis were conducted across study design and domains of the risk of bias assessment. Main Results: Ten studies analysed the effect of attachment-based interventions on the overall psychosocial adjustment of foster or adopted children as reported by their caregivers post intervention. Measures used include the Child Behaviour Checklist, The Strengths and Difficulties Questionnaire, Brief Infant-Toddler Social and Emotional Assessment (BITSEA) and Eyberg Child Behaviour Inventory. The random effects weighted standardised mean difference (SMD) favouring the intervention group was 0.37 (95% CI, 0.10-0.65) and statistically significant. Three studies analysed the effects of attachment-based interventions on the observed attachment security of foster and adopted children as measured by independent observation. Measures include the Strange Situation Procedure, Attachment Q-Set, and The Emotional Availability Clinical Screener. The random effects weighted SMD was 0.59 (95% CI, -0.40-1.57) and not statistically significant. Four studies analysed the effect of attachment-based interventions on positive child behaviour post intervention as measured by independent observation of video-taped interaction between the child and caregivers. Measures include Disruptive Behaviour Diagnostic Observation Schedule (DB-DOS) and Emotional Availability Scales). The random effects weighted SMD was 0.39 (95% CI, 0.14-0.64) and statistically significant. Ten studies analysed the effect of attachment-based interventions on positive parenting behaviour post intervention as measured by independent observation of video-taped interaction between the child and caregivers or coding of audio-taped recordings of parental speech. Measures include Adapted Ainsworth Scales for sensitivity and noninterference, Measurement of Empathy in Adult-Child Interaction, The Dyadic Parent-Child Interaction Coding System, Reflective functioning scale, and Emotional Availability Scales. The random effects weighted SMD was 1.56 (95% CI, 0.81-2.31) and statistically significant. Nine studies analysed the effect of attachment-based interventions on self-reported post intervention parenting stress (Parenting Stress Index). The random effects weighted SMD was 0.24 (95% CI, 0.03-0.46.) and statistically significant. Three studies analysed the effect of attachment-based interventions on parental post intervention self-reported depressive symptoms (Beck Depression Inventory). The random effects weighted SMD was 0.59 (95% CI, -0.08-1.25.) and not statistically significant. Follow-up analyses were carried out for the outcomes externalising behaviour, positive parenting, and parenting stress, but due to the low number of studies, results should be viewed with caution. Results of the single factor sub group moderator analysis suggest that it cannot be ruled out the effects differ depending on whether the interventions take place in the family home or in a clinical setting. However, it is unclear which location is associated with more positive effects as our findings differ between child and parent outcomes. Results of the sensitivity analysis showed no appreciable changes in the results following the removal of any of the studies in any of the analyses. Authors' Conclusions: Parenting interventions based on attachment theory increase positive parent/child interactional behaviours, decrease parenting stress, and increase the overall psychosocial adjustment of children in foster and adoptive families postintervention. Due to the low number of studies evidence regarding the effects of attachment-based parenting interventions on attachment security and disorganised attachment in foster and adopted children was inconclusive. Theoretically, it is possible that child attachment security and/or attachment disorganisation cannot change within the relatively short period of time that parenting interventions typically last. It is possible that if postintervention improvements in parenting behaviours are sustained over time, it may lead to possible improvement in child attachment security and a decrease in child disorganised attachment. Thus, more longitudinal research is needed. Furthermore, evidence regarding the long-term effects of attachment-based parenting interventions on any outcomes was inconclusive due to too few studies, but findings suggest that attachment-based interventions increase positive parenting behaviour at follow-up points 3-6 months after the intervention. No study included in the present review provided a measure of placement stability or breakdown as an outcome, which could be used in the meta-analysis. This further emphasises the need for future longitudinal research in prevention of placement breakdown.

The FACAM study: protocol for a randomized controlled study of an early interdisciplinary intervention to support women in vulnerable positions through pregnancy and the first 5 years of motherhood.

BACKGROUND: Inequality in health can have profound short- and long-term effects on a child's life. Infants develop in a responsive environment, and the relationship between mother and infant begins to develop during pregnancy. The mother's ability to bond with the fetus and newborn child may be challenged by mental health issues which can cause impaired functioning and poorer health outcomes. Families with complex problems need interdisciplinary interventions starting in early pregnancy to be prepared for motherhood and to ensure healthy child development. This study aims to examine the effects of an early and coordinated intervention (the Family Clinic and Municipality (FACAM) intervention) offered to vulnerable pregnant women during pregnancy and the child's first year of life on the mother-child relationship, maternal social functioning, mental health, reflective functioning, well-being, parental stress, and the development and well-being of the child. METHODS: The study is a prospective randomized controlled trial where we will randomize 320 pregnant women enrolled to receive antenatal care at the family clinic at Odense University Hospital, to either FACAM intervention or usual care. The FACAM intervention consists of extra support by a health nurse or family therapist during pregnancy and until the child starts school. The intervention is most intensive in the first 12 months and also includes attachment-based support provided either individually or in groups. The participants are assessed at baseline, and when the infant is 3 and 12 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior (CIB) instrument. Secondary outcomes include prenatal parental reflective functioning, mental well-being, depressive symptoms, breastfeeding duration, maternal satisfaction, child development, parent competence, parental stress, and activities with the child. DISCUSSION: The trial is expected to contribute knowledge about the effect of early coordinated support in antenatal and postnatal care for vulnerable pregnant women and their families. TRIAL REGISTRATION: ClinicalTrials.gov NCT03659721 . Registered on September 6, 2018.

Minding the Baby versus usual care: study protocol for a quasi-cluster-randomized controlled study in Denmark of an early interdisciplinary home-visiting intervention for families at increased risk for adversity.

BACKGROUND: Inequality in health can have profound effects on a child's opportunities later in life. To prevent these downstream effects in families at increased risk of adversity, programs are needed to provide support and improve well-being across several domains. The present trial is aimed at assessing the effectiveness of the Minding the Baby® (MTB) home visiting intervention in improving the mother-child relationship, parental reflective functioning, well-being, and mental health, as well as child development and well-being in families at known risk of adverse health, relational, and developmental outcomes. METHODS: The study is a pragmatic, prospective, quasi-cluster-randomized controlled trial in which seven Danish municipalities were randomized to MTB training in either 2018 or 2019. A total of 250 pregnant women at increased risk of adversity will be recruited (75 care as usual families and 175 intervention families). Care as usual families will be recruited before and after the MTB training. The MTB intervention is an attachment-based, interdisciplinary home visiting intervention offered from the third trimester of pregnancy until the child is 2 years old. The participants are assessed at baseline, and when the infant is 3, 12, and 24 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior scale applied to video recordings of mother-infant interactions. Secondary outcomes include parent-child interaction, parental reflective functioning, parental mental health, maternal satisfaction, parental stress, and child development and well-being. The treatment effect is estimated as a fixed effect using a binary indicator of MTB treatment, and cluster-robust standard errors based on wild bootstrap are used for inference. DISCUSSION: This is the first trial of MTB in a Scandinavian context and will include the largest sample yet in a trial of MTB. The trial is expected to contribute to knowledge about the effect of early support for pregnant women, their infants, and their families at increased risk of adversity. TRIAL REGISTRATION: ClinicalTrials.gov NCT03495895 . The study was registered on April 12, 2018.

Promoting interactive skills and mind-mindedness among early childcare professionals: study protocol for a randomized wait-list controlled trial comparing the Circle of Security approach with care as usual in center-based childcare (the SECURE project).

BACKGROUND: In countries where the majority of young children are enrolled in professional childcare, the childcare setting constitutes an important part of children's caregiving environment. Research consistently shows that particularly the quality of the daily interactions and relationship between young children and their professional caregivers have long-term effects on a range of developmental child outcomes. Therefore, professional caregivers' capacity for establishing high quality interactions with the children in their care is an important target of intervention. METHODS: A prospective, parallel, cluster-randomized wait-list controlled trial is used to test the efficacy of the attachment- and mentalization theory informed Circle of Security (COS) approach adapted to the childcare setting (COS-Classroom) on caregiver interactive skills and mind-mindedness. Participants are professional caregivers of children aged 0-2.9 years working in center-based childcare in Denmark. Approximately 31 childcare centers, corresponding to an estimated 113 caregivers, are expected to participate. The primary outcome is caregiver Sensitive responsiveness measured with the Caregiver Interactive Profile Scales (CIP-scales). Secondary outcomes include caregiver Mind-mindedness, the five remaining CIP-scales (Respect for autonomy, Structure and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions), and caregivers' resources to cope with work-related stress. Data on structural factors (e.g., staff stability, caregiver-child ratio, and level of pre-service education), caregiver attachment style, acceptability and feasibility of the COS-C together with qualitative data on how the participants experience the COS-C is additionally collected to investigate moderating and confounding effects. DISCUSSION: Examining the effectiveness of the COS-C in center-based childcare contributes to the knowledge of evidence-based intervention programs and can potentially improve the caregiver quality early childcare. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04654533. Prospectively registered December 4, 2020, https://clinicaltrials.gov/ct2/show/NCT04654533 .

What do parents think of using informational videos to support recruitment for parenting trials? A qualitative study.

BACKGROUND: Lower than expected recruitment and retention rates are common challenges in parenting trials-particularly for community-based trials targeting parents of young children that rely on face-to-face recruitment by frontline workers. Recruitment requires parental informed consent, yet information sheets have been criticized for being lengthy and complex, and particularly challenging for parents with low literacy. Recent innovations include 'talking head' information videos. This paper aims to explore parent perceptions of using a 'talking head' video to support informed consent, recruitment, and retention procedures in parenting trials. METHODS: We conducted semi-structured interviews with a sample of 24 mothers recruited after their final follow-ups in two different parenting trials in Denmark. Before consenting to participate in the trials, parents were invited to view a video of a member of the study team giving information about the study, and again before the interviews for the current study. The audio data was transcribed and thematic analysis was conducted. RESULTS: We identified three overarching themes: (1) general impression of the video, (2) thoughts on participation in research, and (3) recruitment and retention. Participants were generally positive in their appraisal of the two talking head informational videos. We found that participants felt that a mix of paper-based and video-based sources of information would enable them to make an informed choice about whether to participate in a research study. We also found that a professionally produced video featuring a key member of the study team produced a feeling of commitment to the study that could impact retention rates. CONCLUSIONS: Informational videos are acceptable to parents; however, co-production or participant/patient involvement in the development of such videos is recommended. Informational videos may not increase recruitment but have the potential for improving retention. Key design recommendations are to ensure a 'professional' look to the video, to supplement videos with paper-based information, to keep the length to < 3 min, and for the 'talking head' part to feature a key member of the study team.

Concordance within parent couples' perception of parental stress symptoms among parents to 1-18-year-olds with physical or mental health problems.

Parents of children with physical or mental health problems are at higher risk for experiencing parental stress. However, mothers and fathers may experience parental stress differently. The aim was to examine whether mothers and fathers of children with physical and/or mental health problems are equally inclined within the couples to experience different aspects of parental stress when considering child and parent couple characteristics. Single aspects of Parental stress were assessed with nine items from the Parental Stress Scale in 197 parent couples of children aged 1-18 years with physical and/or mental health problems. Agreement within parent couples for each item was tested using two tests of marginal homogeneity for dependent data: a nominal G2-test and an ordinal γ-test. Analyses were conditioned on child gender, child age, couple educational level, and overall parental stress. For seven aspects of parental stress, differences in agreement within the couples were found with at least one of the conditioning variables. For five aspects (item 3, 4, 9, 10, 13) addressing specific personal experience of daily stressors related to having children and feeling inadequate as a parent, the differences were systematic. Mothers were more inclined to experience these aspect of parental stress than fathers, specially mothers of boys, a younger child, in couples with an education above high school or with a higher stress level. Agreement was found for two aspects (item 14 and 16) of parental stress. This study suggests that mothers' and fathers' experience of most aspects of parental stress vary within the couples. Knowledge on systematic difference between parents' experience of parental stress may inform future interventions. For aspects where mothers generally experience the highest degree of stress, fathers may be involved as support. Future studies may explore the role of diagnoses, coping strategies and examine concordance in parental stress symptoms in other subgroups.

One-year follow-up of The Incredible Years Parents and Babies Program: A pilot randomized controlled trial.

BACKGROUND: The foundation of a healthy life begins in pregnancy and early adversity can have detrimental long-term consequences for affected children. OBJECTIVE: This paper examines the effects of the Incredible Years Parents and Babies program (IYPB) at one-year follow-up when offered as a universal parenting intervention to parents with newborn infants. METHOD: We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to IYPB intervention (n = 76) or usual care (n = 36). The IYPB program is a group intervention with eight two-hour sessions. Follow-up outcomes collected a year after the intervention ended include parental stress, depression, well-being, reflective function, sense of competence, and child cognitive and socio-emotional development. RESULTS: There were no intervention effects on any of the primary or secondary parent-reported outcomes at one-year follow-up when the children were 18 months old. When examining the lowest-functioning mothers in moderator analyses, we found that mothers assigned to the IYPB group reported significantly lower scores for the interest and curiosity subscale of the parent reflective function scale than control mothers (ß=-1,07 [-2.09,-0.06]). CONCLUSION: We found no long-term effects of the IYPB when offered as a universal intervention for a relatively well-functioning group of parents with infants in a setting with a high standard of usual care. The intervention was developed for more vulnerable families in settings with a low level of universal care and the program may be effective for families in those circumstances.