Study Results
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Basic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2009-09-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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).
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.
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.
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).
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).
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.
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.
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).
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).
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).
Interventions
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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.
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.
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 Criteria
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Inclusion Criteria
* 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 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
7 Years
16 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
National University of Singapore
OTHER
Duke-NUS Graduate Medical School
OTHER
Alexandra Hospital
OTHER
Singapore Institute for Clinical Studies
OTHER
Nanyang Technological University
OTHER
National Healthcare Group, Singapore
OTHER_GOV
Responsible Party
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A/Prof Daniel Fung Shuen Sheng
Chairman Medical Board
Principal Investigators
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Daniel SS Fung, A/Prof
Role: PRINCIPAL_INVESTIGATOR
Institute of Mental Health, Singapore
Locations
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Child Guidance Clinic, Health Promotion Board, Institute of Mental Health
Singapore, Singapore, Singapore
Countries
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References
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Raine A, Ang RP, Choy O, Hibbeln JR, Ho RM, Lim CG, Lim-Ashworth NSJ, Ling S, Liu JCJ, Ooi YP, Tan YR, Fung DSS. Omega-3 (omega-3) and social skills interventions for reactive aggression and childhood externalizing behavior problems: a randomized, stratified, double-blind, placebo-controlled, factorial trial. Psychol Med. 2019 Jan;49(2):335-344. doi: 10.1017/S0033291718000983. Epub 2018 May 10.
Liu JC, Raine A, Ang RP, Fung DS. An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids. Ann Acad Med Singap. 2015 Mar;44(3):85-91.
Other Identifiers
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DSRB: A/08/410
Identifier Type: OTHER
Identifier Source: secondary_id
CRC: 240/2008
Identifier Type: OTHER
Identifier Source: secondary_id
CTC: 0800590
Identifier Type: OTHER
Identifier Source: secondary_id
NMRC/1170/2008
Identifier Type: -
Identifier Source: org_study_id
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