Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol.
BACKGROUND
Children with attention deficit hyperactivity disorder (ADHD) are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions.


METHODS
The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms.


CONCLUSIONS
We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone.


BACKGROUND
ClinicalTrials (NCT): NCT00937469.
Child Psychiatric Daytime Clinic, Child and Adolescent Psychiatric Centre, Region Zealand, Holbaek, Denmark. ojst@regionsjaelland.dk
Ole Jakob
OJ
Storebø
Jesper
J
Pedersen
Maria
M
Skoog
Per Hove
PH
Thomsen
Per
P
Winkel
Christian
C
Gluud
Erik
E
Simonsen
D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D002648:Child; D002652:Child Behavior; D003071:Cognition; D003131:Combined Modality Therapy; D003718:Denmark; D004644:Emotions; D005260:Female; D006801:Humans; D008297:Male; D010290:Parents / Q000523:psychology*; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D018401:Sample Size; D012919:Social Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
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