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Emotional Problem clinical trials

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NCT ID: NCT04371263 Completed - Emotional Problem Clinical Trials

How Dose Election Event Will Induce Emotion Change of Emergency Room and Critical Unit

Start date: November 24, 2018
Phase:
Study type: Observational

In response to the emergence of injuries and illnesses, the manpower of the acute and critical medical team has the requirements. The election keen is rare to see in recent years. The results of the election event will inevitably bring to the emergency and critical unit nursing staff and on-site counter personnel. Certain emotional changes is noted and this study is to understand the impact of the emotional adjustment of personnel in acute and critical units on their own work, to understand the situation of on-site personnel, and to avoid excessive planning of manpower, which will help hospital manpower deployment I

NCT ID: NCT04343664 Not yet recruiting - Depression Clinical Trials

Mental Health Assessment Among Community Member During the Covid-19 Pandemic in Indonesia

New
Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community.

NCT ID: NCT04298437 Recruiting - Depression Clinical Trials

Addressing Depression and Positive Parenting Techniques (ADAPT)

ADAPT
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Children with emotional and behavioural difficulties (EBD) experience disproportionate social, family and academic impairment and have between two to five times increased likelihood of developing an anxiety disorder, mood disorder or other severe mental illness in adolescence and adulthood. There is a close association between parental depression and the emergence and maintenance of childhood EBD that is likely bidirectional. Parents of children with EBD experience disproportionate stress, increasing their risk for depression; yet chronic and untreated parental depression is associated with the emergence of child EBD in the first place. Therefore, designing targeted and effective assessment and treatment for parents of children with EBD that take into account parents' depression is necessary. Of pressing concern, first-line Behavioral Parent Training (BPT) treatments for parents of children with EBD are not tailored to parent's mental health needs, which may be why upwards of 40 percent of parents and children treated in these programs fail to sufficiently benefit. Existing research highlights emotional and cognitive factors that may differentiate depressed parents from non-depressed parents that may be treatment targets to improve outcomes for depressed parents and children. The main aim of the proposed project is to evaluate the feasibility and acceptability of a novel targeted treatment for depressed parents of children with EBD, along with adherence to study protocol. The investigators will use the results of the pilot study to make key modifications to study procedures and the treatment itself to increase the success of a future randomized controlled trial (RCT) to test treatment efficacy. The investigators hypothesize that: 1. Recruitment will be feasible. 2. The intervention will be acceptable, and there will be a high rate of adherence to study protocol.

NCT ID: NCT04255472 Recruiting - Clinical trials for Autism Spectrum Disorder

Effectiveness of the WHO Caregivers Skills Training Program

Start date: February 11, 2020
Phase: N/A
Study type: Interventional

Background: Increasing prevalence rates of developmental disorders (DDs) including Autism Spectrum Disorders (ASD) and intellectual disability are a public health priority particularly in Low and Middle Income countries (LIMC) and are included in the World Health Organization (WHO) mhGAP program. However, existing mental health care facilities and resources are insufficient in most low resource settings to cater for this increasing demand. To address this situation, Caregiver Skills Training (CST) program for children with developmental disorders and delays has been developed by the WHO to bridge the treatment gap in low resource settings. Objective: The objective of this study is to evaluate the effectiveness of the WHO CST program plus treatment as usual (TAU) vs. TAU to improve caregiver-child interaction in children with developmental disorders and delays, when implemented by non-specialist health care facilitators in a low-resource rural community settings of Rawalpindi, Pakistan. Methods: A two arm, single blind individual randomized controlled trial (RCT) will be carried out with 160 caregiver-child dyads with development disorders and delays in community settings of Rawalpindi, Pakistan. 160 caregiver-child dyads will be individually randomized on 1:1 allocation ratio into intervention (n=80) and control (n=80) arms. Participants in the intervention arm will receive 3-hours group training sessions of WHO CST program once every week for 9 weeks and 3 individual home sessions delivered via non-specialist health care facilitator over a duration of 3-months. The primary outcome is improvement in play-based caregiver-child interaction at 9-months post-intervention. The secondary outcomes are improvement in routine home-based caregiver-child interaction, child's social communication skills, adaptive behavior, emotional and behavioral problems and parental health related quality of life. The data on health services utilization will also be collected at 9-months post-intervention. Qualitative process evaluation with a sub-sample of study participants and trainers will be undertaken following the RCT. The study will be completed within an estimated period of 11-months. Discussion: Outcomes of the study will be the evidence on the effectiveness of WHO CST program to improve caregiver child interaction and improvement in social communication skills, adaptive behaviors of children with developmental disorders and delays in the low resource setting of Pakistan.

NCT ID: NCT04254393 Completed - Depression Clinical Trials

Early Adolescent Skills for Emotions (EASE)-Pilot Cluster Randomized Controlled Trial (cRCT) in Public Schools of Rural Pakistan

Start date: February 7, 2020
Phase: N/A
Study type: Interventional

Background: Emotional problems such as symptoms of depression, anxiety and psychosocial distress are the leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people, especially those living in adversity. WHO has developed Early Adolescent Skills for Emotions (EASE), a brief group psychological intervention delivered by non-specialist providers for young adolescents impaired by distress and exposed to adversity. We aim to evaluate the feasibility of delivering EASE for young adolescents living in public schools of rural Rawalpindi, Pakistan. Objectives: To evaluate the feasibility of delivering Early Adolescent Skills for Emotions (EASE) program to young adolescents and their caregivers in Rawalpindi, Pakistan to inform the design, including sample size estimation, for a full-scale adequately powered definitive cluster randomised controlled trial. Methods: A two arm, single blind, pilot cluster randomized controlled trial will be conducted with adolescents of both gender (aged 13-15 years) with high psychological distress, studying in grade 8 and 9th of middle and high public school in rural Rawalpindi. Schools will be the units of randomization. 8 public schools, stratified by gender, will be randomized into EASE plus Treatment as Usual (TAU) (n=4) and TAU alone (n=6). 60 young adolescents at-risk of psychosocial distress as assessed by Self-Reported-Pediatric Symptom Checklist (PSC), cut-off ≥28 will be included in the study. No power calculations have been calculated for the present pilot trial; however, the sample will be adequate to inform the parameters of planned definitive cRCT. In the intervention arm, adolescents will receive 7-weekly group sessions and their caregivers will receive 3-weekly group sessions in public schools. Data on the number of outcomes will be collected at baseline, immediately and 3-months' post-intervention follow-up. The findings will inform the sample size required for a definitive trial. A detailed mixed-methods process evaluation will be conducted to identify areas of improvements prior to proceeding to a definitive cRCT. Discussion: The results of pilot trial will be used to inform the design of definitive cluster randomized controlled trial in government led scaled-up implementation of healthy school initiative in Rawalpindi district of Pakistan.

NCT ID: NCT04240340 Completed - Celiac Disease Clinical Trials

Experiences of Disclosure in Adolescents With Coeliac Disease

Start date: March 1, 2020
Phase:
Study type: Observational

Being diagnosed with coeliac disease means that individuals can no longer consume things containing gluten, such as bread or cake, or they can become very ill. This can make situations involving food challenging, such as social situations or lunch at school. The investigators know that being diagnosed with coeliac disease as a teenager can be particularly upsetting and can lead to problems such as anxiety or low mood. Research suggests that when young people are worried about the impact of their condition on their life, they can find it challenging to tell their doctor or ask for support. The investigators would like to understand the experiences of young people with coeliac disease who attend the Paediatric Gastroenterology service at a local children's hospital. The investigators are particularly interested in the reasons why young people either feel able or unable to tell their doctor that they are experiencing difficulties relating to their wellbeing during their appointments, in order to improve support for young people. This study aims to recruit young people between the ages of 11 and 16, who are attending secondary school, to ask them about the things that make it easier or more difficult to share any concerns about their wellbeing with their doctor.

NCT ID: NCT04091633 Completed - ADHD Clinical Trials

School Health Implementation Network: Eastern Mediterranean

SHINE
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

Background An estimated 10-20% of children globally are affected by a mental health problem. Child mental health has been identified as a priority issue by the World Health Organization's Eastern Mediterranean Regional Office (WHO EMRO). Following consultations with international and regional experts and stakeholders, WHO EMRO developed an evidence-based School Mental Health Program (SMHP), endorsed by WHO EMRO member countries, including Pakistan. The federal and provincial health departments in Pakistan made recommendations for a phased implementation of the SMHP in a pilot district. In the formative phase of this program, a number of implementation challenges were identified by the stakeholders. Broadly, these included the need to operationalize and adapt the existing components of the intervention to the local context and to develop sustainable mechanisms for delivery of quality training and supervision. Informed by the results of a formative phase investigations, the SHINE scale-up research team adapted the SMHP (henceforth called Conventional SMHP or cSMHP) to address these implementation challenges. The enhanced version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to cSMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's wellbeing, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings. Objectives The primary objective of the study is to evaluate the effectiveness of eSMHP in reducing socio-emotional difficulties in school-going children, aged 8-13, compared to cSMHP in Gujar Khan, a rural sub-district of Rawalpindi, Pakistan. The secondary objectives are to compare the cost-effectiveness, acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability of scaled-up implementation of eSMHP and cSMHP. It is hypothesized that eSMHP will prove to be both more effective and more scalable than cSMHP. Study population The research is embedded within the phased district level implementation of the cSMHP in Rawalpindi, Pakistan. The study population will consist of children of both genders, aged 8-13 (n=960) with socio-emotional difficulties, studying in rural public schools of sub-district Gujar Khan in Rawalpindi. Design The proposed study design is a cluster randomized controlled trial (cRCT), embedded within the conventional implementation of the SMHP. Following relevant ethics committees and regulatory approvals, 80 eligible schools, stratified by gender, will be randomized into intervention and control arms with a 1:1 allocation ratio. Following informed consent from the parent/ primary caregiver, children will be screened for socio-emotional difficulties using Strengths and Difficulties Questionnaire (SDQ). 960 children scoring > 12 on the teacher-rated SDQ total difficulty scores and > 14 on the parent-rated SDQ total difficulty scores will be recruited and equally randomized into intervention and control arms (480 in each arm). Teachers in the intervention arm will receive training in eSMHP, whereas teachers in the active control will be trained in cSMHP. Trained teachers will deliver the program to children in their respective arms. Outcome measures Primary Outcome: The primary outcome is reduction in socio-emotional total difficulties scores, measured with the parent-rated SDQ, 9 months after commencing intervention delivery. Secondary Outcomes: Implementation data on acceptability, adoption, appropriateness (including cultural appropriateness), feasibility, penetration and sustainability outcomes will be collected from children, parents/primary caregivers, head teachers and teachers. In addition, data will be collected on self-reported Psychological Outcome Profiles (PSYCHLOPS)-KIDS to measure progress on psycho-social problems and wellbeing; annual academic performance; classroom absenteeism, stigmatizing experiences and parent-teacher interaction. Data on teachers' sense of efficacy and subjective well-being, and on the schools' psychosocial environment profile will be collected. All secondary outcome data will be collected at baseline and 9 months after commencing intervention delivery. Outcomes will be analyzed on an intention to treat basis. The role of various factors as potential mediators and moderators eSMHP effectiveness will be explored. Cost-effectiveness evaluation of SMHP shall be evaluated in terms of costs associated with implementation of eSMHP compared with cSMHP.

NCT ID: NCT04002219 Completed - Emotional Problem Clinical Trials

Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease. Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.

NCT ID: NCT04001140 Enrolling by invitation - Behavior Problem Clinical Trials

Enhancement of Emotion Regulation Skills in Adolescents

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

For the current study, a prevention program is developed and applied to enhance the emotion regulation skills of adolescents. Before and after the application of the prevention program, all participants will be assessed for their emotion regulation ability via questionnaires and a physiological examination in which heart rate and skin conductance will be measured.

NCT ID: NCT03856931 Recruiting - Clinical trials for Post Partum Depression

Behaviours and Emotions in Preschoolers

BeEPS
Start date: February 20, 2019
Phase:
Study type: Observational

In this TARGet Kids! Study, we want to find out whether a short questionnaire can be used to help find out about mental health problems in preschool age children.