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NCT03910491
The purpose of the study is to evaluate early implementation outcomes of a positive parenting program, Child Adult Relationship Enhancement in Primary Care (PriCARE), in the foster care setting and to assess the efficacy of PriCARE in promoting positive parenting and increasing empathy among foster caregivers.
NCT06170047
The primary objective of this study is to test the effects of an evidence-based prevention intervention (CPP) adapted for foster and kinship caregivers of young children (FC; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).
NCT04505072
Randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in two youth treatment homes, including 60-70 youth. Inclusion criteria: Youth aged 12-17 years, staying at least 3 months at the home, with intellectual function in the normal range according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as measured by Broset Violence Checklist (BVC). Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition "treatment as usual". After the control period, the control group will receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed at baseline, post-treatment/control period, and 3-6 months post-treatment (at the time when the youth is planned to move from the home) with global assessments of problem severity and improvement by blinded rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. BVC ratings are also made daily by contact persons and teachers during the whole study.
NCT05603000
Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly. This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.
NCT06417125
The goal of this clinical trial is to learn the effect of dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are: * Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam? * Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium. Participants will: * Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication * Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30
NCT05444205
The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.
NCT04440228
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an evidence-based approach for teams that can be adapted for school mental health. TeamSTEPPS has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is designed to build competencies in the areas of leadership, situation monitoring, mutual support, and communication and has been associated with improvements in teamwork and communication as well as patient outcomes, such as decreased seclusion in psychiatric hospitals. This approach has yet to be extended as an implementation strategy in school or community mental health teams. If an evidence-based team approach like TeamSTEPPS can be successfully applied to school mental health teams, it could provide a cost-effective strategy for improving student mental health services and bolstering existing EBP implementation efforts, which to date generally have been insufficient in producing long-term clinician behavior change. In Aim 1 the investigators will capture key stakeholder perspectives about challenges in collocated school mental health services through formative work to inform collaborative planning and capacity building activities in Aim 2. Then, in Aim 2 the investigators will identify inter-organizational challenges and required components of TeamSTEPPS to adapt. The investigators will establish an advisory board and adapt TeamSTEPPS. The product of Aim 2 will be an adapted TeamSTEPPS, directed toward both school mental health and school-employed personnel, and specific, tailored implementation strategies to improve services in schools in conjunction with TeamSTEPPS. Finally, In Aim 3 the investigators will explore the feasibility, acceptability, and utility of TeamSTEPPS and the strategies generated in Aim 2 on inter-professional collaboration, teamwork, and student outcomes in eight schools.
NCT06366620
Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports.
NCT06876246
The Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students/families) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.
NCT06764901
1. Summary The STOP-CSAM Study is a two-armed randomized controlled trial of a non-pharmacological Therapy Chat Service for prevention of Child Sexual Abuse (CSA) and Child Sexual Abuse Materials (CSAM) in self-referred and self motivated patients with high frequent CSAM use and non-detected by the legal authorities. 2. Trial design This study is a prospective multicentred, stratified, parallel-group superiority study conducted in Germany, Czechia and Spain. 3. Background There has been a significant increase in child sexual abuse material (CSAM) on the internet in recent years. The use of CSAM is problematic especially because it creates a demand for and maintains contact child sexual abuse. Unfortunately, despite the significant increase in the number of CSAM users, limited resources are available for investigation and prosecution. Consequently, many users remain in the community, with neither intervention from the criminal justice system, nor the health system. The proposed study will examine whether a therapy chat service (TCS) intervention reduces the demand for, circulation and spread of CSAM in undetected offenders, as compared to a control group. 4. Methods The sample consists of individuals aged 18 years or older (expected N = 630), who have used CSAM in the prior two weeks and are seeking help voluntarily. Participants will be randomized to (1) a Therapy Chat Service (TCS) intervention or (2) a four-week waitlist (control group) followed by a TCS intervention. The TCS intervention group will receive four to six one-hour online therapy chat sessions over the period of four weeks, while the control group will remain on a waitlist for these four weeks before receiving the same TCS intervention. Assessments will be conducted at baseline (pre-intervention) and at 4-, 8-, 12- and 16-weeks post-intervention. The main objective of the study is to compare the effectiveness of TCS in the prevention of CSAM use within a sample of self-referred participants. The primary outcome is the significant decrease of CSAM consumption, which will be assessed by comparing self-reported severity and time spent using CSAM in the two weeks before the intervention and at four weeks following the intervention. Potential progress measures include time spent, severity and frequency of CSAM consumed. Psychological wellbeing and total sexual outlet will be also measured as secondary outcomes, other participant variables such as risk factors for CSAM consumption or sexual interests and therapeutic variables such as number of patient-therapist interactions, modules covered per session, common factors of psychotherapy, adverse effects of intervention and dropout rate will be also measured. Outcomes between groups will be compared following standard principles for RCTs. 5. Results The study will open for recruitment in October 2023, and data collection is expected to be completed by November 2024. The results for the primary outcomes are planned to be analysed by December 2024 and submitted for publication by the end of the project in March 2025. 6. Discussion The study will test whether the TCS intervention has a positive effect, not only in terms of reducing self-seeking potential sexual offenders' problematic sexual behaviours, but also on measures such as psychological wellbeing in CSAM users. Possible adverse effects of TCS intervention will also be assessed. Recently, a similar trial called PRIOTAB-CBT, compared pre- and post-treatment outcome measures between a treatment group to a control group (Lätth et al., 2022). Results showed a significantly larger reduction in time spent using CSAM in the treatment group, in comparison to the control group. PRIOTAB-CBTh was a single-centre, single-blinded, psychological placebo-controlled RCT of an online cognitive behavioural psychotherapy. If the STOP-CSAM trial demonstrates that a TCS intervention reduces CSAM use, it could be an effective prevention strategy for sexual violence against children. 8\. Funding European Commission - Internal Security Fund (ISF-2021).
NCT04702191
Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all. Using a three-armed randomized controlled trial, the aim of the current study is to evaluate the effectiveness of two parenting programs, the Triple P - Positive Parenting Program (group - level 4) and the Circle of Security Parenting Program (group) compared to treatment as usual in Ontario, Canada.
NCT06535100
Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with special needs individuals. It includes mothers who are in service. Caregivers of children with mental special needs may experience mental problems such as anxiety, hopelessness and depression, which negatively affects the caregiver's mental resilience and increases their care burden. In order to reduce the care burden, artistic activities will be organized to express the emotions of caregivers.
NCT06195579
Behavioural problems are prevalent in children, yet the consequences can be significant for the child, family and wider society. Effective intervention is paramount in reducing the impact of childhood behavioural problems. The Nurtured Heart Approach (NHA; Glasser \& Easley, 2016) is an atheoretical parenting intervention which aims to reduce childhood behavioural problems. Although used in clinical practice, there is little empirical research on the effectiveness of the NHA. The aims of the study were to examine whether the NHA reduced parent-reported child behavioural problems, reduced negative parenting practices, and increased parental reflective functioning. The study used a multiple baseline single case design. Parents of children with behavioural problems were recruited from CAMHS waiting lists. The NHA was delivered in a guided self-help format, using the Transforming the Intense Child workbook (Glasser, 2016) and weekly phone calls. Data collection involved psychometric measures of parent-reported child behavioural problems, parenting practices and parental reflecting functioning. Measures were repeated throughout baseline and intervention phases. A follow-up four weeks after the intervention included final measure administration and a change interview. The data were graphed and visually analysed. Supplementary analysis included reliable and clinically significant change, Tau-U and percentage exceeding the median. Framework analysis was used to analyse the change interview.
NCT03283579
This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.
NCT06228950
Current study will be conducted on the Effectiveness of Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students with Visual Impairment. Mindfulness-based Intervention that is Mindfulness-Based Stress Reduction (MBSR) will be used in the current study which is adapted and translated in Urdu language; the pilot trial of MBSR will be conducted after adaptation and translation. The present study will be conducted in two phases * First phase of the study would be a cross-sectional survey in which the researcher will conduct a baseline assessment to identify psychosocial predictors such as psychological distress, parental acceptance and rejection, social support, and mindfulness which are associated with the emotional and behavioural problems of students with visual impairment. Further emotional and behavioural problems of the students with visual impairment will identify. * The second phase of the research would be a Randomized Controlled Trial in which students with Visual Impairment who has scored high on psychosocial predictors and emotional \& behavioural problems would be randomly assigned to intervention \& control groups to get the MBSR training. After the successful training post-assessment would be conducted to check the efficacy of MBSR. * The current study will be conducted in Rawalpindi Islamabad after obtaining permission from the relevant authorities. * Data would be collected from the students with visual impairment and their respective parents.
NCT05681143
Mental health crises involve acute psychiatric states, such as aggression and/or self-injury, which can result in harm to self or others. There is evidence to suggest that 20% to 25% of autistic children are at risk of a mental health crises, however no crisis prevention programs exist for autistic children. The goal of this project is to evaluate, via a randomized design, a novel crisis prevention program.
NCT04547192
Brief Summary: Improving care of the injured (trauma care) is a way to the large burden of injury in low- and middle-income countries. The important initial period of trauma care is often chaotic and prone to errors. The World Health Organization created a Trauma Care Checklist (TCC), which improved key performance indicators of care at tertiary hospitals but encountered factors which decreased its uptake. The investigators propose the use of a model Trauma Intake Form (TIF) with potential to achieve the benefits of the TCC, but with automatic usage and with accompanying improvements in documentation for key elements of care. It is especially oriented for smaller hospitals. The investigators propose a pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design. Specifically, the investigators aim to determine the effectiveness the TIF to function as a checklist for increasing the appropriate use of key performance indicators during care of the injured in emergency units of non-tertiary hospitals in Ghana, as assessed by independent observers; to determine the percent of injured patients with adequate data on initial assessment before vs. after introduction of the TIF in emergency units of non-tertiary hospitals in Ghana; and to increase the capacity of the Kwame Nkrumah University of Science and Technology and the network of non-tertiary hospitals in southern Ghana to undertake high-quality trauma care research, including clinical trials.
NCT04805918
Supportive parenting is a strong predictor of positive outcomes for children, and harsh parenting is a risk factor for child development, especially for the child developing externalizing problems (overactive, oppositional, and aggressive behavior). Externalizing problems in preschoolers are predictive of a variety of problems in later childhood. Thus, parents are key targets for change in preventive programs with children at risk for developing externalizing problems. More than 95% of 2-6 year old Danish children spend an average of 7.5 hours, 5 days a week in a daycare setting, thus pedagogues are key frontline staff in the promotion of parental abilities and early childhood mental health. However, a recent Danish study shows that pedagogues experience a need for systematic skills and methods for intervening in families with a child at risk. Attachment-based programs enhancing parental sensitivity and parental sensitive discipline show promising results. This efficacy study examines the Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD)delivered by 22 VIPP-SD trained pedagogues at home-visits to 120 families with a child (1-6 years) identified to be at risk. Pedagogues are supervised by four VIPP municipality psychologists, thus promoting the cross-disciplinary collaboration. The results will point to future identification of families that may (and may not) profit from a pedagogue delivered VIPP-SD intervention, as well as to revise the intervention in order to maximizing its effect, i.e. point to changes to tailor intervention to the particular needs of different families in a Danish context.
NCT06086639
Feeding problems such as selective eating, loss of appetite, and mealtime behavior problems are common in childhood. Parents play a primary role in learning about feeding, and difficulties experienced in this process may cause the parent to experience stress, despair and exhibit incorrect attitudes. The aim of this study is to examine the effect of online occupational therapy group training for mothers on mothers' attitudes and stress levels, and children's eating behaviors. Mothers of children aged 3-6 years with feeding problems (n=29) were randomly divided into groups. Early Childhood Adaptive Eating Behavior Scale, Feeding Process Mother Attitudes Scale and State-Trait Anxiety Inventory scales were used for evaluation. The mothers in the research group participated in the 4-week training. As a result of the research, positive effects were found on mothers' attitudes and children's eating behaviors (p\<0.05). There was no change in mothers' state and trait anxiety levels (p\>0.05). This study shows that online group training to mothers can support existing therapies and guides clinicians working in the field.
NCT05574569
Emotional and behavioral problems not only affect the Child's life but also have long-lasting effects on families and society and few studies have been carried out to assess these problems. During the critical phase of childhood, a child may face many emotional and social pressures that can develop physical, behavioral, social, and academic problems, negatively impacting on child's school performance, social involvement, self-esteem along with other serious mental health issues. There is a relationship between traditional parenting practices (such as parental control, love, and rejection) and emotional problems of children including depression and anxiety but very little is known about the role of mindful parenting. Globally, many studies have been done on the prevalence of emotional and behavioral problems in children, whereas relatively little is known about the prevalence of child mental health problems and related risk factors in Pakistan. One of the treatments that they are using these days to provide the developmentally appropriate and therefore effective intervention that meets the mental health needs of children is Cognitive Behavior Play Therapy and mindful parenting.