Supplements and Social Skills Intervention Study (SASSI)

This study has been completed.
Sponsor:
Collaborators:
University of Pennsylvania
National University, Singapore
Duke-NUS Graduate Medical School
Alexandra Hospital, Singapore
Singapore Institute for Clinical Studies
Nanyang Technological University, Singapore
Information provided by (Responsible Party):
A/Prof Daniel Fung Shuen Sheng, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:
NCT00819429
First received: January 8, 2009
Last updated: May 13, 2015
Last verified: May 2015
  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:


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


Enrollment: 282
Study Start Date: September 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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).

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pennsylvania
National University, Singapore
Duke-NUS Graduate Medical School
Alexandra Hospital, Singapore
Singapore Institute for Clinical Studies
Nanyang Technological University, Singapore
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, Chairman Medical Board, National Healthcare Group, Singapore
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: May 13, 2015
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 Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Disease
Hyperkinesis
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 05, 2015