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Supplements and Social Skills Intervention Study

A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00819429
Acronym
SASSI
Enrollment
282
Registered
2009-01-09
Start date
2009-09-30
Completion date
2014-06-30
Last updated
2015-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Conduct 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

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.

Interventions

DIETARY_SUPPLEMENTOmega-3

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.

BEHAVIORALSocial Skills Training

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.

OTHERStandard Treatment (or TAU in Child Guidance Clinic)

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).

Sponsors

University of Pennsylvania
CollaboratorOTHER
National University of Singapore
CollaboratorOTHER
Duke-NUS Graduate Medical School
CollaboratorOTHER
Alexandra Hospital
CollaboratorOTHER
Singapore Institute for Clinical Studies
CollaboratorOTHER
Nanyang Technological University
CollaboratorOTHER
National Healthcare Group, Singapore
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reactive - Proactive Aggression Questionnaire (RPQ)48 weeksChanges from baseline to Weeks 12, 24, 36 and 48 in Reactive-Proactive Aggression Questionnaire (Raine et al., 2006) total score

Secondary

MeasureTime frameDescription
Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC)48 weeks
Clinical Global Assessment Scale48 weeksAssessment of the participants's level of general functioning using the Children's Global Assessment Scale

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026