Supplements and Social Skills Intervention Study

Related Clinical Trial
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence Symptoms and Mechanisms of Child Psychiatric Disorders Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances Randomized Feasibility Trial of Mind My Mind Metabolic Effects of Antipsychotics in Children Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to Collaborative Care for Children’s Mental Health Problems Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges Addressing Depression and Positive Parenting Techniques (ADAPT) Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention Phone-Delivered Psychological Intervention (t-CETA) for Mental Health Problems in 8-17 Year-Old Syrian Refugee Children Mindful Parenting and Parent Training Program Study Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder Correlating Real and Virtual World Behavioral Fluctuations in Adolescence Evaluating an Online Parenting Support System Disseminated by Pediatric Practices Study of Cognition and Control in Youths Treatment of Conduct Problems and Depression The Effectiveness of Parent-Child Interaction Therapy (PCIT) School-Based Mental Health Services for Urban Children A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild, Moderate, or Borderline Mental Retardation Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3 Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli Behavioral Sleep Intervention in Children With Disruptive Behaviors Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents Strongest Families Ontario (Formerly the Family Help Program) On-line Treatment for Conduct Problems Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation Supplements and Social Skills Intervention Study Evaluating the Feasibility of Internet-delivered PCIT Resources to Enhance the Adjustment of Children (REACH) Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders Treatment of Children With Peer Related Aggressive Behavior (ScouT) Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children Preschool First Step to Success: An Efficacy Replication Study Home Based Treatment for Drug Use in Early Adolescents Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders Mindfulness-based Program for Children With Disruptive Behavior Disorder Guided Self-Help for Parents of Children With Externalizing Problem Behavior Randomized Controlled Trial of Comet Via the Internet or in Group Format. An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder Evaluation of Regulation Focused Psychotherapy for Children Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth Treatment of Children With Peer Related Aggressive Behavior

Brief Title

Supplements and Social Skills Intervention Study

Official Title

A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity

Brief Summary

      This is a 36-week, randomised, double-blind, placebo-controlled trial. The overarching aim of
      this study is to assess whether a nutritional intervention (Omega-3 supplement), when
      combined with a more traditional treatment approach to conduct disorder and Attention Deficit
      Hyperactivity Disorder (ADHD), is more effective than either approach alone in treating these
      conditions in children and adolescents. The research questions cannot be answered through
      alternative means because disruptive behaviour disorders are primarily childhood disorders.
    

Detailed Description

      Serious adult crime and violence is a social problem despite decades of intervention and
      prevention work. One of the reasons for the world-wide failure to prevent this problem stems
      from (a) a failure to tackle the biological component of the crime/ violence equation in
      treatment programs, and (b) the failure to tackle this adult condition in its formative
      childhood origins. Investing modest resources in early biosocial prevention programs could
      yield enormous long-term financial dividends in terms of the saved legal, medical, social,
      and psychological costs resulting from adult crime. This initial study would be the first to
      test the efficacy of conjoint Omega-3 plus social skills training, and the first to identify
      possible mechanisms by which Omega-3 reduces antisocial behaviour.

      A) Initial evidence for effects of Omega-3 supplementation on conduct disorder and Attention
      Deficit Hyperactivity Disorder (ADHD) B) Moderators of the hypothesised relationship between
      omega-3 supplementation and conduct disorder C) Social skills training as a treatment for
      conduct disorder D) The combined effectiveness of omega-3 and social skills training E)
      Mechanisms of action underlying any treatment effect

      The total daily dosages will be 400 mg of DHA and 600 mg of EPA, typical of prior
      intervention studies of children in the age-range in the proposed study (e.g. Itomura et al.
      2005; Richardson & Puri, 2002).

      The study involves children and adolescents diagnosed with disruptive behaviour disorder
      (DBD, i.e. conduct disorder or oppositional defiant disorder) or attention deficit /
      hyperactivity disorder (ADHD, i.e. combined type or ADHD predominantly inattentive type or
      ADHD predominantly hyperactive-impulsive type). The overarching aim of this study is to
      assess whether a nutritional intervention (Omega-3 supplement), when combined with a more
      traditional treatment approach to conduct disorder and ADHD, is more effective than either
      approach alone in treating these conditions in children and adolescents. The research
      questions cannot be answered through alternative means because disruptive behaviour disorders
      are primarily childhood disorders.

      Violence is a world-wide public health problem that has largely defied successful
      intervention and prevention. The overarching aim of this study is to assess whether a
      nutritional intervention, when combined with social skills training, is more effective than
      either approach alone in reducing childhood conduct disorder, the precursor to adult crime
      and violence. The specific aims are:

      Subjects will consist of 600 male and female children seeking treatment at the Child Guidance
      Clinic.

      Subjects given a primary diagnosis by the attending physician of either a disruptive
      behaviour disorder (DBD, i.e. conduct disorder or oppositional defiant disorder) or attention
      deficit / hyperactivity disorder (ADHD, i.e. combined type or ADHD predominantly inattentive
      type or ADHD predominantly hyperactive-impulsive type) will be included.

      This a randomised, double-blind, placebo-controlled trial with 4 x 3 x 4 x 2 (4 treatments
      groups x 3 diagnostic groups x 4 time measurements of an outcome variable x 2 genders)
      between-subject design to evaluate whether Omega-3 supplement, when combined with social
      skills training, is more effective than either approach alone in reducing childhood conduct
      disorder and attention deficit hyperactivity disorder.
    


Study Type

Interventional


Primary Outcome

Reactive - Proactive Aggression Questionnaire (RPQ)

Secondary Outcome

 Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC)

Condition

Conduct Disorder

Intervention

Omega-3

Study Arms / Comparison Groups

 1
Description:  Omega-3 + Standard treatment
Children in this group will be given 400 mg of DHA and 600 mg of EPA. Caregivers will be instructed to give two 500mg Omega-3 capsules twice a day, at breakfast and at the evening meal for 6 months. Parents will be seen by the attending on a monthly basis for standard treatment procedure.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

282

Start Date

September 2009

Completion Date

June 2014

Primary Completion Date

June 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects between ages 7 and 16 years

          -  Subjects who fulfils all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or
             oppositional defiant disorder

          -  Subjects with willingness to participate in a randomized, double-blind controlled
             trial,

          -  Subjects with complete with written, informed parental consent and assent

          -  Subjects with IQ of 70 or more

        Exclusion Criteria:

          -  Subjects who have IQ in the below 70

          -  Subjects who are younger than 7 years old

          -  Those without written parental consent will not be allowed to participate in the study

          -  Those with brain pathology such as serious head injury, epilepsy will be excluded
      

Gender

All

Ages

7 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Daniel SS Fung, A/Prof, , 

Location Countries

Singapore

Location Countries

Singapore

Administrative Informations


NCT ID

NCT00819429

Organization ID

NMRC/1170/2008

Secondary IDs

DSRB: A/08/410

Responsible Party

Principal Investigator

Study Sponsor

National Healthcare Group, Singapore

Collaborators

 University of Pennsylvania

Study Sponsor

Daniel SS Fung, A/Prof, Principal Investigator, Institute of Mental Health, Singapore


Verification Date

May 2015