Clinical trial NCT00819429: Supplements and Social Skills Intervention Study
Official title: A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conduct Disorder
Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Conduct Disorder
Oppositional Defiant Disorder
Omega 3 Supplements
Social Skills Training
Dietary Intake
Aggression
Nutrition
Disruptive Behaviors Disorder
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
Collaborators: name: University of Pennsylvania
name: National University of Singapore
name: Duke-NUS Graduate Medical School
name: Alexandra Hospital
name: Singapore Institute for Clinical Studies
name: Nanyang Technological University
First posted: 2009-01-09
Enrollment: 282
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reactive - Proactive Aggression Questionnaire (RPQ)
timeFrame: 48 weeks
Secondary outcomes:
measure: Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC)
timeFrame: 48 weeks
measure: Clinical Global Assessment Scale
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Child Guidance Clinic, Health Promotion Board, Institute of Mental Health
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Daniel SS Fung, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raine A, Ang RP, Choy O, Hibbeln JR, Ho RM, Lim CG, Lim-Ashworth NSJ, Ling S, Liu JCJ, Ooi YP, Tan YR, Fung DSS. Omega-3 (omega-3) and social skills interventions for reactive aggression and childhood externalizing behavior problems: a randomized, stratified, double-blind, placebo-controlled, factorial trial. Psychol Med. 2019 Jan;49(2):335-344. doi: 10.1017/S0033291718000983. Epub 2018 May 10.
citation: Liu JC, Raine A, Ang RP, Fung DS. An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids. Ann Acad Med Singap. 2015 Mar;44(3):85-91.