Supplements and Social Skills Intervention Study - Full Text View

Purpose

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.

Condition	Intervention
Conduct Disorder Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder	Dietary Supplement: Omega-3 Behavioral: Social Skills Training Other: Standard Treatment (or TAU in Child Guidance Clinic)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Dietary Supplements

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

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

Primary Outcome Measures:

Reactive - Proactive Aggression Questionnaire (RPQ) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Changes from baseline to Weeks 12, 24, 36 and 48 in Reactive-Proactive Aggression Questionnaire (Raine et al., 2006) total score

Secondary Outcome Measures:

Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Clinical Global Assessment Scale [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Assessment of the participants's level of general functioning using the Children's Global Assessment Scale

Estimated Enrollment:	600
Study Start Date:	September 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Omega-3 + Standard treatment Children in this group will be given 400 mg of DHA and 600 mg of EPA. Caregivers will be instructed to give two 500mg Omega-3 capsules twice a day, at breakfast and at the evening meal for 6 months. Parents will be seen by the attending on a monthly basis for standard treatment procedure.	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. 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).
Experimental: 2 Social skills + Omega-3 placebo + Standard treatment Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months. They will also undergo a manualised group social problem solving skills training protocol of 12 weekly 1-hour sessions (Ang & Ooi, 2003a, 2003b). There will be booster sessions scheduled at 3-week intervals after the initial treatment period of 12 weeks, for a total of 4 booster sessions.	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).
Experimental: 3 Omega-3 + Social skills + Standard treatment Children in this group will receive omega-3 supplement and social skills training on top of standard treatment. Procedures for administration of Omega-3 supplement are similar to those stated in (1) and (2).	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).
Placebo Comparator: 4 Omega-3 placebo + Standard treatment. Children in this group will receive placebo as well as a course of the standard treatment. Procedure for administering the placebo capsules is similar to that outlined in (2).	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).

Eligibility

Ages Eligible for Study:	7 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819429

Locations

Singapore
Child Guidance Clinic, Health Promotion Board, Institute of Mental Health
Singapore, Singapore, 168937

Sponsors and Collaborators

National Healthcare Group, Singapore

Nanchang University

University of Pennsylvania

National University, Singapore

Duke-NUS Graduate Medical School

Alexandra Hospital, Singapore

Singapore Institute for Clinical Studies

Investigators

Principal Investigator:

Daniel SS Fung, A/Prof

Institute of Mental Health, Singapore

More Information

No publications provided

Responsible Party:	A/Prof Daniel Fung Shuen Sheng, Institute of Mental Health
ClinicalTrials.gov Identifier:	NCT00819429 History of Changes
Other Study ID Numbers:	NMRC/1170/2008, DSRB: A/08/410, CRC: 240/2008, CTC: 0800590
Study First Received:	January 8, 2009
Last Updated:	August 13, 2012
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by National Healthcare Group, Singapore:

Attention Deficit Hyperactivity Disorder
Conduct Disorder
Oppositional Defiant Disorder
Omega 3 Supplements
Social Skills Training

Dietary Intake
Aggression
Nutrition
Disruptive Behaviors Disorder

Additional relevant MeSH terms:

Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Hyperkinesis
Mental Disorders Diagnosed in Childhood

Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013

Supplements and Social Skills Intervention Study (SASSI)