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Problem Behavior clinical trials

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NCT ID: NCT06062953 Recruiting - Insomnia Clinical Trials

Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

MEL-QUE
Start date: September 18, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are: - To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia - To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being. Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.

NCT ID: NCT06032455 Recruiting - Clinical trials for Behavioural Problems

Effectiveness of Multisystemic Therapy for Adolescents From Families With Intellectual Disabilities

Start date: September 4, 2023
Phase:
Study type: Observational

The goal of this observational study is to determine the effectiveness of a specialisation of multisystemic therapy (MST) for adolescents with severe behavioural problems from families with an intellectual disability (ID; MST-ID). To achieve this goal, a mixed method study design is used. To this end, a quantitative and a qualitatively primary research question are formulated: - Is MST-ID superior, when compared to standard MST, in reducing rule-breaking behaviour of adolescents (quantitative)? - What are the experiences of adolescents and/or parents receiving MST-ID treatment (qualitative)? Participants will be asked to complete two screeners (questionnaires delivered as a verbal interview) with a total duration of approximately 30 minutes. Other data will be collected through Routine Outcome Monitoring questionnaires that are part of standard MST procedures. To this end, five 'time points' have been identified: T0 (start of MST[-ID] treatment), T1 (end of MST[-ID] treatment), T2 (follow-up 6 month after MST[-ID] treatment), T3 (follow-up 12 month after MST[-ID] treatment), and T4 (follow-up 18 month after MST[-ID] treatment). The qualitative method used to gain insight into families' experiences is determined in consultation with the families. To assess the effectiveness of MST-ID, its treatment outcomes will be compared to standard MST treatment outcomes of families with ID.

NCT ID: NCT06025006 Recruiting - Clinical trials for Severe Psychiatric Disorder

Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team for Homeless People With Severe Psychiatric Disorders Referred to Immediate Referral Procedure: AILSI Program

AILSI
Start date: February 2, 2022
Phase: N/A
Study type: Interventional

People who are homeless with severe psychiatric disorders have to negotiate discontinuous mental health care pathways including high use of emergency departement and enforced hospitalisation, poor access to ambulatory care, poor access to common rights services and a greater risk of incarceration. In order to reduce morbidity, improve social integration and outpatient care for people with severe psychiatric disorders and multiple factors of social vulnerability, the concept of therapeutic jurisprudence has led to the emergence of mental health courts in Anglo-Saxon nations. These courts aim to condition alternatives to incarceration through community-based intensive care (assertive community treatment-ACT). ACT Teams offer direct access to housing without any prerequisite of treatment or abstinence. This model of community-based intensive care tends to demonstrate medical and legal effectiveness while being associated with greater care acceptability by patients. In France, very little data exists on the subject. Médecins du Monde (NGO), in collaboration with the Public Prosecutor's department of Marseille, proposes the implementation of the AILSI strategy for people who homeless with severe psychiatric disorders and referred to immediate referral procedure. The research unit EA 3279 - CEReSS is in charge of the independent evaluation of this innovative intervention. This is an randomized coontrolled study, with two groups: AILSI group (intervention) and TAU group (usual services). A total of 220 patients will be included (100 in the AILSI group / 120 in the TAU group). The main objective is to evaluate the effectiveness of the innovative program (AILSI) compared to usual services by assessing the duration of reincarceration at 18 months in each group, weighted by exposure time. . Duration of inclusion: 30 months; Duration of follow-up: 18 months; Total duration of the study: 54 months. Both quantitative and qualitative analyses will be conducted to address overall outcomes. Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations.

NCT ID: NCT06001892 Recruiting - Adolescent Behavior Clinical Trials

Tennessee Youth Prepared for Success

TYPS
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The principal objective of Tennessee Youth Prepared for Success is to pilot, implement, and test innovative adolescent pregnancy prevention strategies using a randomized controlled trial (RCT) to effectively educate youth on both abstinence and contraception with the goal of reducing youth pregnancies, births, and STIs. Tennessee Youth Prepared for Success will address Adulthood Preparation Subjects (APS) to promote youths' successful and healthy transition to adulthood; include a Positive Youth Development (PYD) approach to engage youth and provide positive influences and skill building opportunities; and implement activities/interventions within a trauma-informed approach to account for the mental health needs of those who have experienced maltreatment, abuse, or violence. The project's goals and principal and subordinate objectives align with the PREIS program's goals/objectives and purpose, including (1) targeting high-risk youth to prevent pregnancy and STIs, including HIV/AIDS; (2) rigorously evaluating interventions using an RCT; (3) manualizing/packaging curriculum; and (4) disseminating lessons learned, best practices, and relevant findings. Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural counties in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth (e.g., systems-involved).

NCT ID: NCT05962424 Recruiting - Clinical trials for Psychiatric Disorder

HNC: Human Neural Circuits Electrophysiology During Cognition

Start date: October 5, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

NCT ID: NCT05928247 Recruiting - Aggression Clinical Trials

Manualized Assessment and Treatment Model of Challenging Behavior

Start date: April 8, 2024
Phase: N/A
Study type: Interventional

Despite decades of mounting single-case-design evidence for the efficacy of applied behavior analysis (ABA) and other approaches for the assessment and treatment of challenging behavior, an evidence-based comprehensive approach remains to exist. The current study will collect test the efficacy of a standardized manual for assessing and treating challenging behavior for individuals with severe and mild challenging behavior.

NCT ID: NCT05925101 Recruiting - Aggression Clinical Trials

Basic and Applied Research on Extinction Bursts

Start date: July 7, 2023
Phase: N/A
Study type: Interventional

Although highly effective, treatments like FCT include extinction, which can have adverse side effects. The extinction burst, an increase in the frequency or intensity of destructive behavior at the start of treatment, is the most common side effect of extinction, and can increase the risk of harm to the patient and others. The goal of the current study is to evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e., rate, magnitude, quality) are manipulated.

NCT ID: NCT05893550 Recruiting - Behavior Problems Clinical Trials

Omega-3 Supplementation to Both Parent and Adolescent

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence. The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.

NCT ID: NCT05866991 Recruiting - Clinical trials for Major Depressive Episode

Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders

SoPsy-SoSad
Start date: February 1, 2023
Phase:
Study type: Observational

Despite international efforts to identify biomarkers of depression, none has been transferred to clinical practice, neither for diagnosis, evolution, nor therapeutic response. This led us to build a French national cohort (through the clinical and research network named SoPsy within the French biological psychiatry society (AFPBN) and sleep society (SFRMS)), to better identify markers of sleep and biological rhythms and validate more homogeneous subgroups of patients, but also to specify the manifestations and pathogeneses of depressive disorders.

NCT ID: NCT05840900 Recruiting - Clinical trials for Postpartum Psychiatric Disorders

Mindfulness, Optimism, and Resilience for Perinatal Health and Equity Study

MORPHE
Start date: February 20, 2024
Phase: N/A
Study type: Interventional

Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.