Establishing consensus on principles and competencies for the use of play in clinical practice in hospitals: An international Delphi study.

Although play has existed in paediatric hospitals for decades, a shared understanding of why and how healthcare professionals use play in clinical practice is lacking. This study aims to reach consensus on a common set of principles and competencies for play interventions and practices in hospitals. We conducted a three-round Delphi study that included healthcare professionals selected by hospital management. The first round comprised open-ended questions on the use of play in clinical practice. Principles and competencies, including learning objectives, were established using content analysis through an iterative process. Participants rated the importance of each principle and learning objective in the second and third rounds. Among the 66 participants, 45 (68%) responded in round 1 and 41 (62%) in rounds 2 and 3. The participants represented ten countries and nine different health professions. After the three rounds, we identified 33 principles and six overall competencies: building trusting relationships; delivering information and increasing understanding; promoting cooperation and participation; reducing procedure-related anxiety and pain; supporting coping and development; and ensuring a professional approach to play, which comprised 20 learning objectives.  Conclusion: According to healthcare professionals, play in clinical practice can be used to communicate and build relationships with paediatric patients and thus potentially help provide patient-centred care. Our findings may help guide and prioritize future research initiatives and operationalize play interventions and practices in hospitals. What is Known: • Evidence suggests that using play in clinical practice can help paediatric patients during hospitals stays. • Despite the evidence supporting the use of play, a shared understanding of why and how paediatric healthcare professionals use play is needed. What is New: • This international Delphi study contributes to a shared interprofessional understanding of the principles, competencies and learning objectives for the use of play in clinical practice. • The findings have the potential to aid initiatives in developing training programmes for healthcare professionals in using play to provide care with a patient-centred approach.

Centring children's lived experiences in understanding the importance of play in hospitals.

BACKGROUND: Children have a right to participate in matters affecting their lives. With increasing regularity, children's perspectives are being sought regarding their health and health care experiences. Though there is evidence that children find play to be one of the 'best' aspects of hospitalisation, studies rarely focus on children's perspectives on play in hospital. METHODS: This qualitative study explored children's lived experiences of play during hospitalisation. Over five months, ethnographic observations were conducted on a paediatric oncology ward as well as interviews with 16 children ages 3-13 years. RESULTS: Using interpretative phenomenological analysis, children's expressions and experiences illuminated three key points: safety and comfort are integral to children feeling able to play in hospital; the value and efficacy of play is decided by children; and that play is a way for patients to be (and be treated as) children first. CONCLUSION: Hospitals can only be child-friendly if children find them friendly. Listening to and integrating children's perspectives in the discourse around the importance of play in hospital is essential for respecting children's rights and delivering person-centred paediatric healthcare.

Can guidance during play enhance children's learning and development in educational contexts? A systematic review and meta-analysis.

This systematic review and meta-analysis considered evidence of guided play compared to direct instruction or free play to support children's learning and development. Interventions from 39 studies were reviewed (published 1977-2020); 17 were included in meta-analysis (Ntotal  = 3893; Mchildage  = 1-8 years; Mgirls 49.8%; Methnicity White 41%, African American/Black 28%, Hispanic 19%). Guided play had a greater positive effect than direct instruction on early maths skills (g = 0.24), shape knowledge (g = 0.63), and task switching (g = 0.40); and than free play on spatial vocabulary (g = 0.93). Differences were not identified for other key outcomes. Narrative synthesis highlighted heterogeneity in the conceptualization and implementation of guided play across studies.

A rapid review of the impact of quarantine and restricted environments on children's play and the role of play in children's health.

Amidst the coronavirus disease 2019 (COVID-19) pandemic, there is uncertainty regarding potential lasting impacts on children's health and educational outcomes. Play, a fundamental part of childhood, may be integral to children's health during crises. We undertook a rapid review of the impact of quarantine, isolation and other restrictive environments on play and whether play mitigates adverse effects of such restrictions. Fifteen peer-reviewed studies were identified, spanning hospitals, juvenile and immigration detention and refugee camps. We found evidence of changes in children's access to play in crises and quarantine. These studies indicated how play might support children enduring isolation but lacked robust investigations of play as an intervention in mitigating impacts of restriction. Studies pertaining to children in isolation due to infectious disease outbreaks were notably absent. It is important that the potential effects of changes to such a crucial aspect of childhood are better understood to support children in this and future crises.

Assessing behavior in children aged 12-24 months using the Strengths and Difficulties Questionnaire.

Behavioral and emotional problems in infants and toddlers are common, often persist and put children at risk of later mental health problems. Reliable, efficient, and sensitive tools are needed to identify young children who may benefit from further assessment and support. The Strengths and Difficulties Questionnaire (SDQ), offers a brief, convenient means of screening for early problems, however, it lacks psychometric validation in infants. The aim of this study was to assess the validity and reliability of the SDQ in children aged 12-24 months. Ninety-three participants, with children aged 12-24 months, completed the SDQ and Child Behavior Checklist (CBCL) online. Concurrent validity of the SDQ was assessed through comparison with the CBCL. The results demonstrated that key subscales of the SDQ and CBCL were significantly correlated (r range= -.19 to -.57). Key SDQ subscales showed moderate reliability (Cronbach's alpha range = .38-.79, mean inter-item correlation range = .06-.43). The SDQ shows promising reliability and validity as a measure for rating the behavior of 12-24-months-old children, particularly for externalizing symptoms. Further research is needed to assess its predictive utility.

"Bursting" to Go and Other Experiences.

Children's use of the toilet at school, although rarely explored, is an important facet of school experience with consequences for physical and psychological health. A mixed methods study investigated views of 25 children (4-5 years) regarding potential stressors in the first school year, including views of toileting, in Dublin, Ireland. Despite very positive responses to school, most responses to toileting (15 of 25) were mixed or negative. Although some liked to go, or noted the toilets were clean, most indicated delayed toilet use ("bursting" to go) and ambivalent or negative experiences such as fear of not identifying the right toilet, fear of being alone, lack of privacy, and potential bullying. Many children did not expect to receive help from the teacher. As delaying toilet use can have lasting health consequences, teacher-nurse collaboration could be used to develop whole-school policies to support children's early adjustment in this sensitive area of functioning.

Brief report: a comparison of saliva collection methods with preschool children: the perspectives of children, parents, and childcare practitioners.

Saliva offers developmental researchers and pediatric clinicians significant opportunities to measure numerous biological markers. However, many preschool-aged children refuse to participate in saliva collection. Identifying collection methods known to be acceptable to participants may help in maximizing participation. To this end, this study aimed to determine the relative acceptability of three different collection methods (passive drool, hydrocellulose microsponges, and polymer swabs) to children and their caregivers. Interviews were carried out with 15 preschool children (age range 32-66 months, M=43.65, SD=8.45), their parents, and childcare practitioners. Although children reported no overall preference for a specific method, parents and practitioners selected hydrocellulose microsponges most often as their preferred method.

Maternal anxiety and depression and their associations with mother-child pretend play: a longitudinal observational study.

BACKGROUND: Parental anxiety and depression have been associated with changes to parent-child interactions. Although play constitutes an important part of parent-child interactions and affords critical developmental opportunities, little is known regarding how parental anxiety and depression are related to parent-child play. This is an important knowledge gap because parents play a crucial role in children's early play experience. The purpose of the current study was to examine whether levels of maternal anxiety and depression respectively predicted frequencies of pretend play in both mothers and their children, and whether mothers' engagement in pretend play predicted child behaviour problems two years later. METHODS: Pretend play in 60 mother-toddler dyads (Mage of child = 29.67 months, SD = 3.25, 41.7% girls) was assessed during home visits. Maternal anxiety and depression were assessed using self-report questionnaires. Children's behaviour problems were rated by mothers at baseline and two years later. Hierarchical regression analyses examined concurrent associations between mother-child pretend play and maternal anxiety and depression at baseline, and longitudinal associations between baseline mother pretend play and child behavioural problems two years later. RESULTS: Higher maternal anxiety predicted less pretend play in mothers and children (ß = - .23, BCa 95% CI: [- .018, - .001]) and ß = - .22, BCa 95% CI [- .014, - .001]). Higher maternal depression predicted less child pretend play (ß = - .20, BCa 95% CI [- .012, - .001]). There was evidence (albeit weak) that more mother pretend play at baseline predicted fewer child behaviour problems two years later (ß = - .18, BCa 95% CI [- 62.38, 11.69]), when baseline child behaviour problems and maternal anxiety were controlled for. CONCLUSIONS: Maternal anxiety and depression are associated with less pretend play during mother-child interaction. Mother's pretend play might help reduce child behavioural problems risks, suggesting that play might be one mechanism by which maternal mental health influences children's development.

A video-feedback parenting intervention to prevent enduring behaviour problems in at-risk children aged 12-36 months: the Healthy Start, Happy Start RCT.

BACKGROUND: Behaviour problems emerge early in childhood and place children at risk for later psychopathology. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of a parenting intervention to prevent enduring behaviour problems in young children. DESIGN: A pragmatic, assessor-blinded, multisite, two-arm, parallel-group randomised controlled trial. SETTING: Health visiting services in six NHS trusts in England. PARTICIPANTS: A total of 300 at-risk children aged 12-36 months and their parents/caregivers. INTERVENTIONS: Families were allocated in a 1 : 1 ratio to six sessions of Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) plus usual care or usual care alone. MAIN OUTCOME MEASURES: The primary outcome was the Preschool Parental Account of Children's Symptoms, which is a structured interview of behaviour symptoms. Secondary outcomes included caregiver-reported total problems on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The intervention effect was estimated using linear regression. Health and social care service use was recorded using the Child and Adolescent Service Use Schedule and cost-effectiveness was explored using the Preschool Parental Account of Children's Symptoms. RESULTS: In total, 300 families were randomised: 151 to VIPP-SD plus usual care and 149 to usual care alone. Follow-up data were available for 286 (VIPP-SD, n = 140; usual care, n = 146) participants and 282 (VIPP-SD, n = 140; usual care, n = 142) participants at 5 and 24 months, respectively. At the post-treatment (primary outcome) follow-up, a group difference of 2.03 on Preschool Parental Account of Children's Symptoms (95% confidence interval 0.06 to 4.01; p = 0.04) indicated a positive treatment effect on behaviour problems (Cohen's d = 0.20, 95% confidence interval 0.01 to 0.40). The effect was strongest for children's conduct [1.61, 95% confidence interval 0.44 to 2.78; p = 0.007 (d = 0.30, 95% confidence interval 0.08 to 0.51)] versus attention deficit hyperactivity disorder symptoms [0.29, 95% confidence interval -1.06 to 1.65; p = 0.67 (d = 0.05, 95% confidence interval -0.17 to 0.27)]. The Child Behaviour Checklist [3.24, 95% confidence interval -0.06 to 6.54; p = 0.05 (d = 0.15, 95% confidence interval 0.00 to 0.31)] and the Strengths and Difficulties Questionnaire [0.93, 95% confidence interval -0.03 to 1.9; p = 0.06 (d = 0.18, 95% confidence interval -0.01 to 0.36)] demonstrated similar positive treatment effects to those found for the Preschool Parental Account of Children's Symptoms. At 24 months, the group difference on the Preschool Parental Account of Children's Symptoms was 1.73 [95% confidence interval -0.24 to 3.71; p = 0.08 (d = 0.17, 95% confidence interval -0.02 to 0.37)]; the effect remained strongest for conduct [1.07, 95% confidence interval -0.06 to 2.20; p = 0.06 (d = 0.20, 95% confidence interval -0.01 to 0.42)] versus attention deficit hyperactivity disorder symptoms [0.62, 95% confidence interval -0.60 to 1.84; p = 0.32 (d = 0.10, 95% confidence interval -0.10 to 0.30)], with little evidence of an effect on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The primary economic analysis showed better outcomes in the VIPP-SD group at 24 months, but also higher costs than the usual-care group (adjusted mean difference £1450, 95% confidence interval £619 to £2281). No treatment- or trial-related adverse events were reported. The probability of VIPP-SD being cost-effective compared with usual care at the 24-month follow-up increased as willingness to pay for improvements on the Preschool Parental Account of Children's Symptoms increased, with VIPP-SD having the higher probability of being cost-effective at willingness-to-pay values above £800 per 1-point improvement on the Preschool Parental Account of Children's Symptoms. LIMITATIONS: The proportion of participants with graduate-level qualifications was higher than among the general public. CONCLUSIONS: VIPP-SD is effective in reducing behaviour problems in young children when delivered by health visiting teams. Most of the effect of VIPP-SD appears to be retained over 24 months. However, we can be less certain about its value for money. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58327365. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 29. See the NIHR Journals Library website for further project information.

Behaviour problems in young children are common and are linked to mental and physical health problems, and educational and social difficulties. An important factor that influences the development of behaviour problems is the quality of care that children receive from their caregivers. This study aimed to test if a six-session parenting programme [called Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD)] reduced behaviour problems in children aged 1 or 2 years who were showing early signs of behaviour problems (e.g. restlessness, impulsivity, tantrums and aggression). VIPP-SD supports caregivers in responding to their child's communication and behaviour. A total of 300 families participated. All families continued to access usual health-care services (e.g. health visitors and general practitioners), but half of the families were randomly allocated to also receive the VIPP-SD programme. We visited all families when the study started, and at 5 and 24 months to see if the children whose families received VIPP-SD showed fewer behaviour problems. We measured the children's behaviour by completing interviews and questionnaires with their caregivers. We also analysed whether or not VIPP-SD was good value for money compared with existing services. We did this by comparing the cost of all of the standard health and community services that families accessed during their time in the study, taking account of the impact that VIPP-SD had on children's behaviour. The children in the VIPP-SD group had lower levels of behaviour problems following the programme than children whose parents did not receive the programme. On average, VIPP-SD children scored 2 points lower on the main measure of behaviour; an example difference would be tantrums being rated as mild rather than severe. By the 2-year visit, the VIPP-SD children continued to show lower levels of behaviour problems. It is less clear whether or not VIPP-SD is good value for money, as this depends on how much money policy-makers are willing to invest for reductions in behaviour problems. Overall, there is strong evidence that the VIPP-SD programme is effective in reducing behaviour problems in the short term. Most of this benefit appears to be maintained for the following 2 years. However, we are less certain about the long-term effect and the VIPP-SD's value for money.

A Brief Home-Based Parenting Intervention to Reduce Behavior Problems in Young Children: A Pragmatic Randomized Clinical Trial.

Importance: Behavior problems are one of the most common mental health disorders in childhood and can undermine children's health, education, and employment outcomes into adulthood. There are few effective interventions for early childhood. Objective: To test the clinical effectiveness of a brief parenting intervention, the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD), in reducing behavior problems in children aged 12 to 36 months. Design, Setting, and Participants: The Healthy Start, Happy Start study was a 2-group, parallel-group, researcher-blind, multisite randomized clinical trial conducted via health visiting services in 6 National Health Service trusts in England. Baseline and 5-month follow-up data were collected between July 30, 2015, and April 27, 2018. Of 818 eligible families, 227 declined to participate, and 300 were randomized into the trial. Target participants were caregivers of children who scored in the top 20% for behavior problems on the Strengths and Difficulties Questionnaire. Participants were randomly allocated on a 1:1 basis to receive either VIPP-SD (n = 151) or usual care (n = 149), stratified by site and number of participating caregivers. Analysis was performed on an intention-to-treat basis. Statistical analysis was performed from September 5, 2019, to January 17, 2020. Interventions: All families continued to access usual care. Families allocated to VIPP-SD were offered 6 home-based video-feedback sessions of 1 to 2 hours' duration every 2 weeks. Main Outcomes and Measures: The primary outcome was the score on an early childhood version of the Preschool Parental Account of Children's Symptoms, a semistructured interview of behavior symptoms, at 5 months after randomization. Secondary outcomes included caregiver-reported behavior problems on the Child Behavior Checklist and the Strengths and Difficulties Questionnaire. Results: Among 300 participating children (163 boys [54%]; mean [SD] age, 23.0 [6.7] months), primary outcome data were available for 140 of 151 VIPP-SD participants (93%) and 146 of 149 usual care participants (98%). There was a mean difference in the total Preschool Parental Account of Children's Symptoms score of 2.03 (95% CI, 0.06-4.01; P = .04; Cohen d = 0.20 [95% CI, 0.01-0.40]) between trial groups, with fewer behavior problems in the VIPP-SD group, particularly conduct symptoms (mean difference, 1.61 [95% CI, 0.44-2.78]; P = .007; d = 0.30 [95% CI, 0.08-0.51]). Other child behavior outcomes showed similar evidence favoring VIPP-SD. No treatment or trial-related adverse events were reported. Conclusions and Relevance: This study found that VIPP-SD was effective in reducing symptoms of early behavior problems in young children when delivered in a routine health service context. Trial Registration: isrctn.org Identifier: ISRCTN58327365.

Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial.

BACKGROUND: Reaching recruitment targets in randomised controlled trials is a challenge. Media tools are increasingly used to engage participants, yet there is a paucity of research into the use of video to optimise recruitment. We therefore tested whether adding a participant information video clip to a standard participant information sheet improved recruitment into a parenting trial. METHODS: One hundred seven participants were randomised to receive either a participant information sheet (n = 51) or an informational video clip (n = 56) as part of an email contact following a screening phase. All participants went on to receive the information sheet as part of the existing consent procedure. RESULTS: The video condition did not increase the odds of recruitment into the trial, such that those in the video condition were significantly less likely to participate in the main trial (OR = 0.253, CI = 0.104-0.618, p = 0.003). CONCLUSION: The introduction of a video clip into the recruitment stages of a parenting trial did not lead to an improvement in recruitment; however, the small sample size precludes definitive inferences. We offer reflections on challenges encountered in implementing the SWAT and suggestions for other researchers seeking to embed recruitment SWATs into similar trials. TRIAL REGISTRATION: Current controlled trials ISRCTN 58327365 . Registered on 19 March 2015. SWAT REGISTRATION: SWAT 106; Effects of a video clip on recruitment into a randomised trial. Registered on 20 December 2016.

Association of Maternal and Paternal Depression in the Postnatal Period With Offspring Depression at Age 18 Years.

Importance: Paternal depression during the postnatal period has been associated with adverse child outcomes. Family environment has been reported as a pathway for risk transmission from fathers to children. The influence of paternal depression during the postnatal period on offspring depression remains to be clarified. Objective: To investigate the association between paternal depression in the postnatal period and offspring depression and explore potential mediating and moderating factors that influence any association between paternal and offspring depression. Design, Setting, and Participants: This prospective study of a UK community-based birth cohort (the Avon Longitudinal Study of Parents and Children) of parents and their adolescent offspring investigated associations between paternal depression during the postnatal period and offspring depression at age 18 years. We tested a hypothesized moderator (ie, sex) and conducted path analysis to examine hypothesized mediators (ie, depression in the other parent, couple conflict, and paternal involvement and emotional problems, conduct problems, and hyperactivity in offspring at age 3.5 years) of the associations between both paternal and maternal depression and offspring depression. Data collection for the Avon Longitudinal Study of Parents and Children began in 1991 and is ongoing. Data analysis for this study was conducted from June 2015 to September 2018. Exposures: Depression symptoms in fathers at 8 weeks after the birth of their children. Main Outcomes and Measures: Offspring depression symptoms at age 18 years, using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes. Results: A total of 3176 father-offspring pairs were analyzed; of the children, 1764 were girls (55.5%) and 1412 (44.5%) were boys. Paternal mean (SD) age at delivery was 29.6 (9.6) years. The offspring of fathers who had depression during the postnatal period were at increased risk of experiencing depression symptoms at age 18 years (ß = 0.053 [95% CI, 0.02-0.09]). The association is mediated by maternal depression at 8 months after birth (ß = 0.011 [95% CI, 0.0008-0.02]; 21% [0.011/0.053]) and conduct problems at 42 months after birth (ß = 0.004; [95% CI , -0.00004 to 0.009]; 7.5% [0.004/0.053]). Couple conflict and paternal involvement do not mediate this association. The increased risk is seen in girls but not boys (interaction ß = 0.095; P = .01). Conclusions and Relevance: The association between paternal depression in the postnatal period and depression in girls at age 18 years is partially explained by maternal depression. Couple conflict and paternal involvement were not found to play a role in the risk of transmission; this contrasts with the role that couple conflict was found to play in the risk of childhood behavior problems. Conduct problems in childhood appear to be a pathway for risk transmission between paternal depression and subsequent depression in offspring at age 18 years.

Parenting and child mental health.

This paper reviews parenting programmes and their effectiveness with families of young children and highlights additional resources for primary care practitioners. Typically, 30% of GP consultations concern child behaviour problems and established behaviour problems can have lasting effects on children's life chances. These problems can be identified in infancy and toddlerhood.Parenting is a key risk factor in their development and maintenance, yet is also amenable to change. In this paper we consider six parenting programmes that are widely evaluated and/or available in the U.K. and their evidence base . These include two NICE recommended parenting programmes (Incredible Years and Triple P), which offer tiered and flexible parenting programmes; predominantly for parents of school-age children. We also review Parent-Infant Psychotherapy, which is typically for parents of younger children. Fourth is Family Nurse Partnership, an intensive programme to support young, first-time mothers. Finally we consider, video feedback programmes which use video to focus in detail on parents' interactions with their children, including Video Feedback to Promote Positive Parenting and Video Interactive Guidance. These interventions demonstrate the range of approaches which are being used to intervene early in children's lives to try to prevent the development of enduring behavioural problems. WHY THIS MATTERS TO ME: It is becoming increasingly clear that the origins of many mental health problems lie in childhood. Family factors, including the quality of care that parents provide for their children, can make a huge difference to children's early life pathways, for better or for worse. Understanding how best to intervene to support parents is a key challenge. In this article, we critically review the most widely used parenting programmes for parents of young children. It is imperative that we judge these early interventions to high standards so that we are offering children the best start in life. KEY MESSAGE: Parenting programmes offer a means to intercept behaviour problems in early childhood before they become established.

Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial.

OBJECTIVE: This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children's school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems. METHODS: Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing. RESULTS: The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM). Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday. CONCLUSION: The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments.

Preventing enduring behavioural problems in young children through early psychological intervention (Healthy Start, Happy Start): study protocol for a randomized controlled trial.

BACKGROUND: Behavioural problems are common in early childhood, and can result in enduring costs to the individual and society, including an increased risk of mental and physical illness, criminality, educational failure and drug and alcohol misuse. Most previous research has examined the impact of interventions targeting older children when difficulties are more established and harder to change, and have rarely included fathers. We are conducting a trial of a psychological intervention delivered to families with very young children, engaging both parents where possible. METHODS: This study is a two-arm, parallel group, researcher-blind, randomized controlled trial, to test the clinical effectiveness and cost-effectiveness of a parenting intervention, Video Feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) for parents of young children (12-36 months) at risk of behavioural difficulties. VIPP-SD is an evidence-based parenting intervention developed at Leiden University in the Netherlands which uses a video-feedback approach to support parents, particularly by enhancing parental sensitivity and sensitive discipline in caring for children. The trial will involve 300 families, who will be randomly allocated into either an intervention group, who will receive the video-feedback intervention (n = 150), or a control group, who will receive treatment as usual (n = 150). The trial will evaluate whether VIPP-SD, compared to treatment as usual, leads to lower levels of behavioural problems in young children who are at high risk of developing these difficulties. Assessments will be conducted at baseline, and 5 and 24 months post-randomization. The primary outcome measure is a modified version of the Preschool Parental Account of Child Symptoms (Pre-PACS), a structured clinical interview of behavioural symptoms. Secondary outcomes include caregiver-reported behavioural difficulties, parenting behaviours, parental sensitivity, parental mood and anxiety and parental relationship adjustment. An economic evaluation will also be carried out to assess the cost-effectiveness of the intervention compared to treatment as usual. DISCUSSION: If shown to be effective, the intervention could be delivered widely to parents and caregivers of young children at risk of behavioural problems as part of community based services. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN58327365 . Registered 19 March 2015.

Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

UNLABELLED: This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. TRIAL REGISTRATION: ISRCTN Registry ISRCTN04631728.