Conduct DisorderSASSINCT00819429
Supplements and Social Skills Intervention Study
A study testing Omega-3, Social Skills Training and Standard Treatment (or TAU in Child Guidance Clinic) in people with Conduct Disorder and Attention Deficit Hyperactivity Disorder, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Conduct Disorder, Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder
- What is being tested?
- Omega-3, Social Skills Training and Standard Treatment (or TAU in Child Guidance Clinic)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Child Guidance Clinic, Health Promotion Board, Institute of Mental Health
Singapore, Singapore, 168937
About this study
Official title: A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity
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.
Read the 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.
- 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.
- Being tested
- Omega-3, Social Skills Training, Standard Treatment (or TAU in Child Guidance Clinic)
- Keywords
- Attention Deficit Hyperactivity Disorder, Conduct Disorder, Oppositional Defiant Disorder, Omega 3 Supplements, Social Skills Training, Dietary Intake, Aggression, Nutrition, Disruptive Behaviors Disorder
- Medical subject headings
- Conduct Disorder, Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
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 TrainingBehavioural
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)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Dietary Supplement: Omega-3; Other: Standard Treatment (or TAU in Child Guidance Clinic) |
| 2 | Experimental | 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. Receives: Behavioral: Social Skills Training; Other: Standard Treatment (or TAU in Child Guidance Clinic) |
| 3 | Experimental | 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). Receives: Dietary Supplement: Omega-3; Behavioral: Social Skills Training; Other: Standard Treatment (or TAU in Child Guidance Clinic) |
| 4 | Placebo comparator | 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). Receives: Other: Standard Treatment (or TAU in Child Guidance Clinic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive - Proactive Aggression Questionnaire (RPQ)
Changes from baseline to Weeks 12, 24, 36 and 48 in Reactive-Proactive Aggression Questionnaire (Raine et al., 2006) total score
Measured: 48 weeks
Secondary outcomes (2)
Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC)
Measured: 48 weeks
Clinical Global Assessment Scale
Assessment of the participants's level of general functioning using the Children's Global Assessment Scale
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Collaborators
- University of Pennsylvania, National University of Singapore, Duke-NUS Graduate Medical School, Alexandra Hospital, Singapore Institute for Clinical Studies, Nanyang Technological University
- Responsible party
- Principal investigator, A/Prof Daniel Fung Shuen Sheng, National Healthcare Group, Singapore
- Investigators
- Daniel SS Fung, A/Prof, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819429
- Sponsor's protocol ID
- NMRC/1170/2008
- Other IDs
- DSRB: A/08/410, CRC: 240/2008, CTC: 0800590
- Acronym
- SASSI
- Status last verified
- May 2015
- First submitted
- 8 Jan 2009
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29743128Liu 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.
PubMed 25882235
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional and Social Skills Intervention on Conduct Disorder and Hyperactivity
- ClinicalTrials.gov ID
- NCT00819429
- Acronym / sponsor ID
- SASSI / NMRC/1170/2008
- Keywords
- Attention Deficit Hyperactivity Disorder, Conduct Disorder, Oppositional Defiant Disorder, Omega 3 Supplements, Social Skills Training, Dietary Intake, Aggression, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Collaborators
- University of Pennsylvania, National University of Singapore, Duke-NUS Graduate Medical School, Alexandra Hospital, Singapore Institute for Clinical Studies, Nanyang Technological University
- Study start
- Sep 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Omega-3, Other: Standard Treatment (or TAU in Child Guidance Clinic)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. |
| 2 | Experimental | Behavioral: Social Skills Training, Other: Standard Treatment (or TAU in Child Guidance Clinic)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. |
| 3 | Experimental | Dietary Supplement: Omega-3, Behavioral: Social Skills Training, Other: Standard Treatment (or TAU in Child Guidance Clinic)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). |
| 4 | Placebo comparator | Other: Standard Treatment (or TAU in Child Guidance Clinic)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). |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-31000mg 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. | Dietary supplement | 1, 3 |
| Social Skills Training1 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. | Behavioural | 2, 3 |
| 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). | Other | 1, 2, 3, 4 |
Primary outcome
Reactive - Proactive Aggression Questionnaire (RPQ)
Time frame: 48 weeks
Changes from baseline to Weeks 12, 24, 36 and 48 in Reactive-Proactive Aggression Questionnaire (Raine et al., 2006) total score
2 secondary outcomes
Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC)
Time frame: 48 weeks
Clinical Global Assessment Scale
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Derived from this study: PubMed 29743128Raine 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.
- Derived from this study: PubMed 25882235Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel SS Fung, A/Prof principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3, Social Skills Training and Standard Treatment (or TAU in Child Guidance Clinic) in people with Conduct Disorder and Attention Deficit Hyperactivity Disorder, run by National Healthcare Group, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive - Proactive Aggression Questionnaire (RPQ) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819429, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.