Supplements and Social Skills Intervention Study

NCT00819429 | Completed DMC

• 4 other identifiers: NMRC/1170/2008DSRB: A/08/410CRC: 240/2008CTC: 0800590
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Conduct Disorder; Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Conduct Disorder; Oppositional Defiant Disorder; Omega 3 Supplements; Social Skills Training; Dietary Intake; Aggression; Nutrition; Disruptive Behaviors Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  48 weeks

Secondary Outcomes (2)

• Computerised Diagnostic Interview Schedule for Children - Version IV (C-DISC)

  48 weeks

• Clinical Global Assessment Scale

  48 weeks

Study Arms (4)

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.

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.

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).

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).

Other: Standard Treatment (or TAU in Child Guidance Clinic)

Interventions

Omega-3 DIETARY_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.

1; 3

Social Skills Training BEHAVIORAL

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.

2; 3

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).

1; 2; 3; 4

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Healthcare Group, Singapore: lead
• University of Pennsylvania: collaborator
• National University of Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Alexandra Hospital: collaborator
• Singapore Institute for Clinical Studies: collaborator
• Nanyang Technological University: collaborator

Study Sites (1)

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

Singapore, Singapore, 168937, Singapore

Location

Related Publications (2)

• 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.

  PMID: 29743128 DERIVED

• 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.

  PMID: 25882235 DERIVED

MeSH Terms

Conditions

Conduct Disorder; Attention Deficit Disorder with Hyperactivity; Oppositional Defiant Disorder; Aggression

Interventions

Docosahexaenoic Acids; Child Guidance Clinics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Community Mental Health Centers; Ambulatory Care Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Daniel SS Fung, A/Prof

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Medical Board

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

SG (1)