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Conduct Disorder clinical trials

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NCT ID: NCT05875363 Completed - Clinical trials for Attention Deficit Disorder With Hyperactivity

Neurodevelopmental Disorders in Youth With Criminal Behaviors

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

1. Describe the prevalence of neurodevelopmental disorders among youth with criminal behaviors 2. Explore the relationship between specific neurodevelopmental disorders and the rates and types of crime 3. Examine the roles of psychiatric comorbidities and sociodemographic factors in juvenile criminality

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: NCT03971682 Completed - Conduct Disorder Clinical Trials

The Efficacy of a Compassion Focused Therapy-based Intervention in Detained Youth

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

This non-randomized controlled trial with a control group aimed to assess the efficacy of a 20-session individualized Compassion Focused Therapy-based intervention, the PSYCHOPATHY.COMP, in reducing psychopathic traits (primary outcomes), aggression, shame, emotion regulation problems, and fears of compassion, as well as in increasing social safeness, self-compassion, and compassion towards others (secondary outcomes). The PSYCHOPATHY.COMP's impact on psychophysiological (i.e., Heart Rate/Heart Rate Variability) and behavioral indicators (i.e., number disciplinary infractions and number of days in punishment) were also tested, in order to ascertain if changes observed in self-report questionnaires were reflected in more adjusted psychophysiological and behavioral patterns. Mental Health disorders, as well as the number of Conduct Disorder criteria, were also tested as moderators of treatment effects.

NCT ID: NCT03927612 Completed - Virtual Reality Clinical Trials

Virtual Reality to Improve Social Perspective Taking

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

This project will examine how virtual reality treatment that provides users with the alternate perspective of a virtual interpersonal interaction impacts psychological and neurobiological markers of social perspective taking in children with a disruptive behavior disorder. The investigators anticipate that experiencing a virtual encounter from a counterpart's point-of-view improves a child's perspective taking and alters brain function related to imagining another person's pain.

NCT ID: NCT03905785 Completed - Clinical trials for Mental Health Wellness 1

Effectiveness of Parenting Intervention for Improving Child Mental Health

Start date: February 12, 2018
Phase: N/A
Study type: Interventional

In this study, effectiveness of a group parenting intervention was assessed in a community setting, for its impact on child behaviour problems and parental mental health.

NCT ID: NCT03887312 Completed - Depression Clinical Trials

Phone-Delivered Psychological Intervention (t-CETA) for Mental Health Problems in 8-17 Year-Old Syrian Refugee Children

t-CETA
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of t-CETA, a version of Common Elements Treatment Approach (CETA) adapted to be delivered over the telephone, in treating common mental health problems in 8-17 year old Syrian refugee children living in Lebanon. Children will be randomly assigned to receive either t-CETA or treatment as usual provided by Médecins du Monde, an NGO providing medical and mental health services to Syrian refugees in Lebanon. If families do not agree to randomisation, they will be offered t-CETA and their data will be used to evaluate implementation and acceptability of the intervention. Symptoms of common mental health problems, including anxiety, depression, PTSD, and behavioural problems, and psychological well-being, will be measured before treatment, immediately after treatment, and three months after treatment is completed. Groups will be compared to determine if t-CETA is at least as effective as standard treatment provided by Médecins du Monde.

NCT ID: NCT03796663 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Mindful Parenting and Parent Training Program Study

Start date: December 18, 2018
Phase: N/A
Study type: Interventional

The Mindful Parenting and Parent Training Study will be investigating the combination of Bögels and Restifo's (2014) Mindful Parenting Program and Chorpita and Weisz's (2009) Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH) Program, specifically the BPT module. The Mindful Parenting Program is an adaptation for parents of the Mindfulness-Based Cognitive Therapy, and the Mindfulness-Based Stress Reduction program; the program will consist of 7-weekly 2.5-hour parent group sessions. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1.5-hour sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection. Both evaluation and treatment services will be offered at no cost to study participants. Parents, children, and teachers will also be offered monetary incentive to thank them for their time and effort completing study related assessments throughout the course of the study to determine if the combination of the Mindful Parenting Program with BPT improves functioning in children with disruptive behavioral problems, as well as the parent-child relationship and the parent's acquisition and enactment of the skills they learn in BPT.

NCT ID: NCT03749824 Completed - ADHD Clinical Trials

Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3

Start date: August 2011
Phase: N/A
Study type: Interventional

This study investigates the psychophysiological responses to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three months: 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their omega-3/placebo condition clinical diagnosis.

NCT ID: NCT03725371 Completed - ADHD Clinical Trials

Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli

Start date: August 2011
Phase:
Study type: Observational [Patient Registry]

This study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Data was gathered about participants' level of aggression through the Reactive-Proactive Aggression Questionnaire (RPQ). The stimuli that were presented to the participants included 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their RPQ scores and clinical diagnosis.

NCT ID: NCT03535805 Completed - Anxiety Clinical Trials

Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances

MindMyMind RCT
Start date: September 7, 2017
Phase: N/A
Study type: Interventional

Background Impairing emotional and behavioural problems are common in children and adolescents and mark a three-fold increased risk of mental disorder in young adulthood. Evidence-based psychological interventions are recommended for indicated prevention and first-line treatment, but access to treatment is often limited. A new, modular cognitive and behavioural therapy program Mind My Mind (MMM) comprising evidence-based interventions for children with emotional and behavioral problems was designed to be delivered by educational psychologists in the Danish municipalities. A feasibility RCT (NCT03448809), demonstrated that the study design was acceptable among children, parents, and therapists, and it provided data to estimate the sample size needed for the definitive RCT. The investigators test the hypothesis that the parent-reported impact of mental health problems will be significantly lower for children in the MMM group as compared with children in the TAU group after the 18-week intervention period (primary hypothesis), and after follow-up at week 26 (first secondary hypothesis). Aim To investigate the effects and cost-effectiveness of MMM compared with TAU for children and adolescents with impairing anxiety, depressive symptoms and/or behavioral problems. Both beneficial and harmful effects are evaluated. Methods The study compares the new modular MMM with TAU for children aged 6-16 years with anxiety, depressive symptoms or behavioral problems impacting on their daily and social life. The trial is conducted in four Danish municipalities in the period from September 2017 to April 2019. Participants are children with indicated needs. The parents sign up the child for assessment in the Pedagogical Psychological Services in the Municipalities. The assessment includes web-based standardized questionnaires for child and parent: 1) the strengths and difficulties questionnaire (SDQ), 2) Spence Children's Anxiety Scale, 3) Mood and Feelings Questionnaire, and 4) family, social and school functioning. The questionnaires are supplemented with a clinical psychopathological interview by a trained psychologist. The investigators exclude children with 1) low levels of problems and no indicated needs, or 2) high levels of problems and need of referral to the Child and Adolescent Psychiatry. 412 children will be included and randomized (1:1) to MMM versus TAU. MMM is supported by a central organization, who is responsible for the education and weekly supervision of the therapists, and the web-based data collection and feedback of data in real time to therapists and researchers. All outcomes are self-, parent- and teacher-reported scores on standardized questionnaires administered at baseline, week 18 and week 26. At entry, the child and the parents own description of the Top-problem is recorded and scored on a 10-point likert scale. The Top-problem and impact of problem is scored by parent and child every second week during the intervention period, and the progress is monitored by the therapists in the MMM group. Information on costs is gathered through administrative registers and questionnaires at baseline, week 18, and week 26. Primary objectives and outcome measures This primary outcome is measured with the parent-reported SDQ impact-scale. The minimum relevant difference in impact of mental health problems was set at 1.0 corresponding to a change from severe to moderate, or from moderate to little-or-no impact in one of five domains of child's life: distress, home-life, friendships, classroom learning and leisure activities. Secondary objectives and outcomes measures The key secondary hypotheses are that the children in the MMM group will show significantly lower levels of parent-reported anxiety, depressive symptoms, functional impairment, Top-problems and behavioural problems, and better school attendance and quality-of-life as compared with the children in the TAU group at week 18. All other outcomes are explored at week 18 and 26, including the primary and secondary measures of potential harm: 1) youths with severe and increased levels of self-reported suicidality, hopelessness and/or negative self-evaluation, and 2) youths with poor quality of life in relation to family, free time and friends. Statistical analyses All analyses will be intention-to-treat with two-sided significance tests. The investigators will use mixed models with repeated measures for continuous outcomes and generalized linear mixed model for binary and non-normally distributed outcomes. For the key secondary outcomes, the investigators will use the strategy of hierarchical testing allowing us to preserve the level of significance, α=0.05, as long as the null hypotheses are rejected. The incremental cost-effectiveness ratio will be calculated to analyze cost-effectiveness. Perspectives The results will guide policy makers in deciding whether to implement modular CBT-programs like the MMM.