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Problem Behavior clinical trials

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NCT ID: NCT01887132 Terminated - Clinical trials for Autism Spectrum Disorders

A Trial of the Drug Donepezil for Sleep Enhancement and Behavioral Change in Children With Autism

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Background: - Some children with autism spectrum disorders (ASD) do not have normal sleep cycles. Some of these children spend very little time in the rapid eye movement (REM) stage of sleep. Some studies suggest that less time in REM sleep can be associated with learning and behavior problems. Donepezil is a medication used to treat Alzheimer s disease. Donepezil can increase REM sleep in some adults with different disorders. A small study showed that Donepezil can also increase REM sleep in children with ASD. Researchers now want to see if Donepezil can improve communication skills and social interaction in children with ASD. They also want to see if any change in symptoms seems to come from changes in REM sleep. Objectives: - To see if a medication, Donepezil, can improve the way communication skills and social interaction develop in young children with autism spectrum disorders. Eligibility: - Children 22 to 44 months of age with ASD. Design: - Participants will be screened with a blood test, heart tests, and a sleep study. During the sleep study, children will sleep in a darkened room for 2 nights with electrodes on their body and a tube under their nose. Parents can sleep in the room with their child. A technician will monitor the room all night. - Participants will take the study medication once a day. - Treatment will be monitored at visits every 3 months. At each visit the participant will take blood tests, heart tests, or behavior tests. Participants will have 2 more sleep studies. - Participation will end after 18 months.

NCT ID: NCT01871324 Withdrawn - Behavioral Changes Clinical Trials

The Efficacy of Group Therapy in Ultra-Orthodox Jewish Young Men Diagnosed With Type One Diabetes

Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the influence of an intervention program especially designed to young ultra orthodox men that were diagnosed with diabetes type one.

NCT ID: NCT01866956 Completed - Clinical trials for Psychiatric Disorder

Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders

Start date: September 1, 2016
Phase:
Study type: Observational

The KSADS-COMP will facilitate identification of comorbid psychiatric and substance use diagnoses frequently missed in clinical practice, and improve adolescent treatment outcomes. The self-administered version of the KSADS-COMP can also be used cost-effectively in schools and juvenile justice settings where there is a growing interest in early identification and referral of youth in need of mental health services. The KSADS-Bridge assessment tool with its RDoC neurocognitive tasks, when completed with the self- or clinician administered KSADS-COMP, will help to create cross-talk between the DSM and RDoC diagnostic perspectives, and begin to generate a database on the relationship between RDoC constructs and treatment outcomes across a range of diagnostic categories.

NCT ID: NCT01822366 Completed - Depressive Symptoms Clinical Trials

Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya

Start date: August 2012
Phase: N/A
Study type: Interventional

The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts. Building on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.

NCT ID: NCT01795508 Completed - Clinical trials for Child Behavior Problems

Parent Management Training, Oregon

PMTO
Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to examine the effects of Parent Management Training Oregon (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing behavioral problems.

NCT ID: NCT01786733 Completed - Depressive Symptoms Clinical Trials

Behavioral Activation - From Inpatient to Outpatient Services

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.

NCT ID: NCT01750996 Completed - Clinical trials for Disruptive Behavior Disorder

Strongest Families Finland Canada: Family-based Prevention and Treatment Program of Early Childhood Disruptive Behavior

Fin-Can
Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of the Strongest Families Finland Canada project is to help parents develop skills to strengthen their families and reduce disruptive behavior in their 4 year old children.

NCT ID: NCT01670227 Completed - Clinical trials for Behavior Problems of Childhood and Adolescence

ParentCorps: Promoting Healthy Development in Children From Low Income Communities

ParentCorps
Start date: September 2005
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether ParentCorps promotes academic achievement and prevents mental health problems in children living in disadvantaged urban communities

NCT ID: NCT01651442 Completed - Primary Insomnia Clinical Trials

Sequenced Therapies for Comorbid and Primary Insomnias

Start date: August 1, 2012
Phase: N/A
Study type: Interventional

Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive-behavioral therapies (CBTs) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared the psychological/behavioral therapies and BzRAs for insomnia treatment. Moreover, insomnia treatment studies have been limited by small, highly screened study samples, fixed-dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-report or polysomnographic (PSG) sleep parameters as outcomes, rather than on more clinically relevant indicators of remission. Finally, studies have yet to test the benefits of treatment sequencing for those who do not respond to initial their insomnia therapy. This multi-site project will address these limitations. Two study sites will enroll a total of 224 participants who meet broad criteria for a chronic insomnia disorder, and a sizeable portion (60%) of this sample will have insomnia occurring comorbid to a psychiatric disorder. Participants will be evaluated with clinical assessments and PSG, and then will be randomly assigned to first-stage therapy with an easy-to-administer behavioral insomnia therapy (BT) or zolpidem (most widely prescribed BzRA). Centrally trained therapists will administer therapies according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those not achieving remission will be offered re-randomization to a second, 6-week treatment involving pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy-CT). All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Our over-arching goal is to obtain new information that aids in the development of clinical guidelines for managing insomnia sufferers with and without comorbid psychiatric conditions.

NCT ID: NCT01640600 Completed - Motor Development Clinical Trials

Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children

PABKids
Start date: October 2011
Phase: N/A
Study type: Observational

The purpose of this project is to conduct a follow-up study with women that had participated in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink and Blue Kids Study is a follow-up study with the mothers and also with the children they were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8 years old, which is a perfect time to look at developmental outcomes in children. This study will look at children with exposure to nicotine or antidepressants during pregnancy, as well as children who were not exposed. The investigators hypothesis is that children who were exposed to either nicotine or antidepressants in pregnancy will have poorer developmental outcomes than children who were not exposed. The investigators are also interested in determining whether nicotine exposure or antidepressant exposure results in poorer outcomes. The investigators specific aims are: 1. To determine whether pre-school and school aged offspring exposed to maternal cigarette smoking or antidepressants during pregnancy are more likely to have social-emotional problems compared to children who were not exposed to cigarettes or antidepressants during pregnancy. 2. To determine whether pre-school and school aged children who were exposed to prenatal maternal cigarette smoking or antidepressants during pregnancy display cognitive impairments as compared to children who were not exposed to either prenatal maternal cigarette smoking or antidepressants. 3. To determine if pre-school and school aged children who were exposed to maternal prenatal cigarette smoking or antidepressants display impaired motor development as compared to children who were not exposed to maternal cigarette smoking or antidepressants in pregnancy.