Supplements and Social Skills Intervention Study

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.

Conditions

• Conduct Disorder
• Attention Deficit Hyperactivity Disorder
• Oppositional Defiant Disorder

Interventions

DIETARY_SUPPLEMENT

Omega-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.

BEHAVIORAL

Social 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.

OTHER

Standard 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 & Collaborators

• University of Pennsylvania

  collaborator OTHER

• National University of Singapore

  collaborator OTHER

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Alexandra Hospital

  collaborator OTHER

• Singapore Institute for Clinical Studies

  collaborator OTHER

• Nanyang Technological University

  collaborator OTHER

• National Healthcare Group, Singapore

  lead OTHER_GOV

Principal Investigators

• Daniel SS Fung, A/Prof · Institute of Mental Health, Singapore

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

7 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• Singapore

Study Locations