Supplements and Social Skills Intervention Study - Full Text View

Supplements and Social Skills Intervention Study (SASSI)

This study is not yet open for participant recruitment.

Verified by National Healthcare Group, Singapore, January 2009

First Received: January 8, 2009 No Changes Posted

Sponsors and Collaborators:	National Healthcare Group, Singapore National University, Singapore Alexandra Hospital, Singapore McGill University Nanchang University University of Pennsylvania
Information provided by:	National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:	NCT00819429

Purpose

The purpose of this study is to assess how various treatments work. We will be looking specifically at a nutritional intervention using omega 3 supplements and a social skills training and comparing how they can be beneficial to children with conduct problems.

Condition	Intervention
Conduct Disorder	Dietary Supplement: Omega-3 Behavioral: Social Skills Training Other: IMH Standard treatment pathway

MedlinePlus related topics: Dietary Supplements Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity

Further study details as provided by National Healthcare Group, Singapore:

Primary Outcome Measures:

Changes from baseline to Weeks 12 and 24 in Reactive-Proactive Aggression Questionnaire total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Omega-3 only	Dietary Supplement: Omega-3 1000mg Omega-3 given twice a day for 6 months
2: Experimental Social skills plus omega-3 placebo	Behavioral: Social Skills Training 1 hourly sessions over 12 weeks duration and 4 booster sessions at 3 weeks intervals
3: Experimental Omega-3 plus social skills	Dietary Supplement: Omega-3 1000mg Omega-3 given twice a day for 6 months Behavioral: Social Skills Training 1 hourly sessions over 12 weeks duration and 4 booster sessions at 3 weeks intervals
4: Placebo Comparator Standard treatment plus Omega-3 placebo	Other: IMH Standard treatment pathway Consultation with attending psychiatrist and may include parent management training and/or recieving medication according to diagnosis.

Eligibility

Ages Eligible for Study:	9 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects between ages 9 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 9 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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Institute of Mental Health ( A/prof Daniel Fung Shuen Sheng )
Study ID Numbers:	NMRC/1170/2008, DSRB: A/08/410, CRC: 240/2008, CTC: 0800590
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819429 History of Changes
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by National Healthcare Group, Singapore:

Attention Deficit Hyperactivity Disorder
Conduct Disorder
Opppositional Defiance Disorder

Omega 3 Supplements
Social Skills Training
Dietary Intake

Study placed in the following topic categories:

Conduct Disorder
Attention Deficit Disorder with Hyperactivity
Mental Disorders

Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

Additional relevant MeSH terms:

Conduct Disorder
Pathologic Processes
Disease

Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders

ClinicalTrials.gov processed this record on May 06, 2009