Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol

TY - JOUR

T1 - Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol

AU - Storebø, Ole Jakob

AU - Pedersen, Jesper

AU - Skoog, Maria

AU - Thomsen, Per Hove

AU - Winkel, Per

AU - Gluud, Christian

AU - Simonsen, Erik

PY - 2011/1/21

Y1 - 2011/1/21

N2 - 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/Design: 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.Discussion: 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.Trial registration: ClinicalTrials (NCT): NCT00937469.

AB - 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/Design: 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.Discussion: 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.Trial registration: ClinicalTrials (NCT): NCT00937469.

KW - Attention Deficit Disorder with Hyperactivity

KW - Child

KW - Child Behavior

KW - Cognition

KW - Combined Modality Therapy

KW - Denmark

KW - Emotions

KW - Female

KW - Humans

KW - Male

KW - Parents

KW - Psychiatric Status Rating Scales

KW - Questionnaires

KW - Research Design

KW - Sample Size

KW - Social Behavior

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/1745-6215-12-18

DO - 10.1186/1745-6215-12-18

M3 - Journal article

C2 - 21255399

SN - 1745-6215

VL - 12

SP - 18

JO - Trials

JF - Trials

ER -