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Problem Behavior clinical trials

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NCT ID: NCT04926064 Completed - Clinical trials for Child Behavior Problem

Young Children's Sleep Patterns and Problems Among Turkish Children

Start date: April 1, 2021
Phase:
Study type: Observational

Sleep is important for optimal child growth, development, and family functioning. Behavioral pediatric insomnia is one of the most prevalent sleep disorders identified in young children. Well-child visits represent an important setting for addressing concerns regarding the child's sleep patterns and sleep problems. Investigators aimed to describe sleep/wake patterns of young children, evaluate the associations between parental depressive, and anxiety symptoms, parental involvement in child-care, sleep-related behaviors and children's sleep parameters. The study has a descriptive cross-sectional study design. An estimated sample size was 2089 participants considering the number of children aged between 6-36 months in the country, and the estimated prevalence of Behavioral Insomnia being 30%. A multi-stage stratification is used to calculate the number of participants to be taken at the level of 12 geographical regions according to Nomenclature of Territorial Units for Statistics (NUTS-1). A sleep study group is established by the study coordinator, and researchers running a well-child outpatient clinic from each region across the country are included. Investigators invite mothers of children aged 6 to 36 months who either visited for a well-child outpatient clinic or in the waiting list for follow up to complete the online questionnaire about their children's sleep/wake patterns utilizing mailing lists obtained from the outpatient clinics. Recruitment will take place from April to June 2021. The questionnaire included Brief Infant Sleep Questionnaire (BISQ), Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder (GAD-7) scale, and separate questions on fathers' involvement in child care, and sociodemographic characteristics. An online google survey is developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. The questionnaire takes approximately 20 minutes to complete.

NCT ID: NCT04888780 Completed - Behavioral Symptoms Clinical Trials

Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Objective: This study was conducted to determine the effect of diabetes training on HbA1c, levels of depression and quality of life of Type 1 Diabetes Mellitus adolescents by using the Web-Based Watson Human Care Model. Methods: The study was conducted with 30 adolescents between 11-18 years old who was followed by Child Endocrinology Department and who accepted to participate in the research. A web page was developed by considering Training Guide for Adolescents with Type 1 Diabetes and processes of Watson Human Care Theory. Live video interviews were done with adolescents in the experiment group on 14 sessions and these interviews were recorded.

NCT ID: NCT04846608 Completed - Clinical trials for Behavioral Disorders

Descriptive Study of Emergency Room Visits From Nursing Home Residents for Behavioral Problems at the Nancy University Hospital: Place of the Advanced Practice Nurse

Start date: April 14, 2021
Phase:
Study type: Observational

The demographic evolution of old age is a reality. After the age of 75, 2 out of 3 people living in institutions have neurocognitive disorders. Behavioural disorders such as physical aggression, agitation, hallucinations, sleep disorders, generate difficulties in the management of these patients and lead to unscheduled emergency hospitalizations. Non-pharmacological management of behavioral disorders is recommended as a first-line treatment because of its low risk and potential improvement (Haute Autorité de Santé 2009). However, this management is not simple and obvious to put in place, especially since not all elderly people with Behavioural disorders are in adapted structures. The advanced practice nurse specializing in geriatrics has a place in this care pathway. Because of her skills, she could "organize multi-professional care, set up analyses of practices within the nursing homes, train caregivers appropriately, and limit hospitalizations due to behavioral problems" (SALIEGE L. 2020). Advanced practice nursing is in its infancy in France, and everything remains to be done (International Council of Nurses- directive). The aim of the study is to identify the number of emergency room visits by people aged 75 and over for behavioral problems in nursing home during a 6 month-period.

NCT ID: NCT04804917 Completed - Depressive Symptoms Clinical Trials

3-year Follow-up of the Mind My Mind RCT

MindMyMindFU
Start date: March 22, 2021
Phase:
Study type: Observational

This is a three-year follow up of a previously completed randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" [MMM]) compared to management as usual (MAU) in youth with emotional and behavioral problems. The effectiveness trial (Clinical Trials Identifier: NCT03535805) evaluated an intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized treatment. The experimental intervention MMM consisted of 9-13 weekly, individual therapy sessions delivered by psychologists in a non-specialist school-based setting. The CBT-methods were organized in modules for anxiety, depression and/or behavioral problems, and the therapy was completed within 17 weeks. The MAU was enhanced by two care-coordination visits to help coordinate the usual care in the four municipalities in Denmark. The trial was conducted in four diverse municipalities in Denmark. The aim of this study is to determine the long-term effects of the transdiagnostic, modular CBT program ("Mind My Mind" [MMM]) compared to management as usual (MAU). The three-year follow-up of the RCT of MMM versus MAU is nested in a larger study of help-seeking youth screened for eligibility and stratified into three groups with increasing severity of problems. Youths with an intermediate level of problems were included in the RCT. We screened 573 help-seeking youths, and we included and randomized a total of 396 youths (age 6-16 years, with anxiety, depressive symptoms, and/or behavioral problems) to MMM (n=197) or MAU (n=199). The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups. The follow-up study does not include an intervention. The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries.

NCT ID: NCT04786080 Completed - Mental Health Issue Clinical Trials

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE).

SPARKLE
Start date: May 19, 2021
Phase: N/A
Study type: Interventional

Throughout the COVID-19 pandemic, reduced access to childcare, money- and health-related worries and extended confinement and social isolation have placed great pressure on many families. There is evidence that many parents in the UK have struggled to manage their children's behaviour. For instance, Co-SPACE, an ongoing UK-wide study led by the University of Oxford, found a significant increase in parents reporting behavioural problems in children and an increase in family-related stress in response to various local and national lockdowns. Co-SPACE has also found up to 70% of parents reported wanting additional support. The SPARKLE (Supporting Parents and Kids through Lockdown Experiences) study aims to address this pressing need. SPARKLE is a rapid-deployment randomised controlled trial evaluating whether a digital public health parenting intervention can help parents to manage their children's behaviour problems, as impacted by the COVID-19 UK pandemic and lockdowns. We aim to evaluate whether the negative effects of the pandemic can by reversed by providing parenting advice digitally, using a specially-designed app, Parent Positive. The Parent Positive app will provide advice to parents through animations, delivering messages carefully selected by parents and experts in the field. The messages will be supplemented with practical parenting resources and an opportunity to network with other parents for peer support. The animations are light-hearted, humorous and non-judgmental and are delivered by eight high-profile celebrities who are also parents. The SPARKLE study will involve 616 Co-SPACE parents, half of whom will receive access to the Parent Positive app and half who won't.

NCT ID: NCT04778163 Completed - Clinical trials for Psychiatric Disorder

The Use of Humor With Young Adults in Psychiatric Care

Start date: September 19, 2019
Phase: N/A
Study type: Interventional

Clinical study in psychiatry in young adult patients between 18 and 25 years old. The aim of the study is to evaluate the therapeutic impact of the clinical use of humor through 6 group sessions (group of 5 to 10 patients), at the rate of one hour session per week for 6 weeks. The investigators will form 2 groups of 5 to 10 patients matched in terms of gender, education level and score on a scale measuring their sense of humor. The participants will be asked to complete a series of tests measuring their ability to use humor, psychiatric symptoms and well-being. Group 1 (test group) will participate in the humor-based sessions, while Group 2 (control group) will receive regular treatment for 6 weeks (waiting list: patients in Group 2 will attend humor-based sessions once Group 1 has completed their 6 weeks). At the end of the 6-week sessions, both groups will receive the same series of pre-session tests to see whether or not there has been improvement in their overall functioning, psychiatric symptomatology and appreciation/use of humor. At the end of the 2x 6-week sessions, group 2 will again receive this series of pre-session tests to see whether or not their overall functioning, psychiatric symptomatology and appreciation/use of humour has improved. Objective(s)/Aim: To evaluate the resilience of young adult psychiatric patients and their ability to cope with stress through the use of humor in a set of 6 modules on the use of humor. To evaluate the symptoms. Outcome/Endpoints : Using scales, measure this evolution.

NCT ID: NCT04760795 Completed - Aging Clinical Trials

Stress, Personality, Attachment and Coping During the Covid Crisis.

STERACOVID
Start date: November 15, 2020
Phase:
Study type: Observational

Because of containment due to Covid-19, the French High Authority for Health (HAS) recommended reinforced monitoring of patients taken in care in the psychiatric ward, with special attention for people over the age of 65. To meet this recommendation, the geriatrics department of the hospital of Charity of Saint-Etienne hospital and the Vinatier hospital in Lyon organized follow-up of these patients by telephone throughout the containment period, thus allowing continuity of care. This pandemic situation and these measures are unprecedented; it is difficult to anticipate the psychological impact on patients.

NCT ID: NCT04752605 Completed - Executive Function Clinical Trials

Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to examine the effectiveness of a play-based intervention designed to support the development of executive functioning in 3-5-year-old children. The intervention is implemented in the day care setting as a part of early childhood education in collaboration with parents and local healthcare and social welfare workers. The study hypothesizes that the intervention as an add-on to normal early childhood education brings added benefits to the development of children's executive functioning in comparison to early childhood education without the add-on.

NCT ID: NCT04749745 Completed - Clinical trials for Psychiatric Disorder

Effects of L-theanine on Motor Cortex Excitability in Healthy Subjects: A Paired-Pulse TMS Study

Start date: June 9, 2020
Phase: Early Phase 1
Study type: Interventional

Major depressive disorder (MDD) is a serious mental illness and the leading cause of disability worldwide. New pharmacotherapeutic agents with complementary neurobiological mechanism and better side effect profile are of great needs. In addition to the monoamine system, the glutamatergic system plays a crucial role in MDD. L-theanine (N5-ethyl-L-glutamine) is the primary psychoactive component uniquely in green tea. Preclinical studies have demonstrated anti-depressant effect of L-theanine in rodents and provided evidences for its pharmacological properties of N-methyl-D-aspartate (NMDA) and gamma-aminobutyric acid (GABA) agonism. Yet these effects have not been proven in humans. Only one open-label clinical trial has studied and supported antidepressant effects of L-theanine in MDD patients. We propose using pair-pulse transcranial magnetic stimulation (ppTMS) to probe how L-theanine may manipulate the glutamatergic and GABA systems in the frontal region by changing cortical excitability first in healthy subjects. We plan to investigate the neurobiological effects of L-theanine in healthy subjects first. Granted that the first phase pilot trial provides neurophysiological evidence of L-theanine on motor cortex excitability in human subjects, next phases of studies on L-theanine in MDD patients cortical excitability could be justified.

NCT ID: NCT04726449 Completed - Clinical trials for Psychiatric Disorder

Observatory of Psychiatric Symptoms and Their Somatic Causes in Urgent Medical Care

OPOSSUM
Start date: May 11, 2021
Phase:
Study type: Observational

Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement We hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the Emergency Room (ER) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation. Every patient visiting the ER for psychiatric symptoms will be included. The usual physical examination by the ER physician will be associated with two psychometric tests (namely the Clock-drawing test and Frontal Assessment Battery test). The follow up will be made after 3 months in order to have the final diagnosis. Neurological data and data from the FAB test and the Clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.