Supplements and Social Skills Intervention Study
Condition: Conduct Disorder; Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

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.
    

Intervention name(s): Omega-3; Social Skills Training; Standard Treatment (or TAU in Child Guidance Clinic)
Intervention type(s): Dietary Supplement; Behavioral; Other
Intervention description(s): 1000mg of Omega-3 supplement will be given twice a day for a duration of 6 months. All supplements (including placebo) will be administered as two 500mg softgels twice daily, to be taken during breakfast and during the evening meal.; 1 hourly sessions over 12 weeks duration and 4 booster sessions at 3 weeks intervals. During these 16 sessions, children are taught empathy, pro-social skills, and a variety of positive coping techniques for problem-solving, emotional regulation, conflict resolution, and anger management via the use of practical strategies, materials, activities, role-play and games.; Standard treatment is administered on a monthly basis to the parents of the child participants by the clinicians. Parents will be provided Parent Management Training where they will be taught behaviour and parenting techniques and may be referred to a parent support group. There is clinical pathway for the management of ADHD in our department which will be adhered to (i.e., Clinical Pathway for ADHD).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Conduct Disorder; Oppositional Defiant Disorder; Omega 3 Supplements; Social Skills Training; Dietary Intake; Aggression; Nutrition; Disruptive Behaviors Disorder