Social Skills Training and Standard Treatment Versus Standard Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The primary purpose of the trial is to examine the effect of the combination of social skills
      training, parental training and standard treatment versus standard treatment in ADHD
      patients.

      The secondary purpose is to examine differences in the effect of the treatment in relation to
      the different competences of attachment: secure attachment: unsecure dismissing, unsecure
      preoccupied or disorganized attachment and in the categories; emotional openness, balance of
      positivity / negativity to attachment figure/s, idealisation of attachment figure/s,
      dismissal and/or derogation of attachment, the ability of conflict resolution,
      disorganisation and coherence of the narrative description.

      The tertiary purpose of the trial is to examine differences in the effect of the treatment in
      relation to the degree of parents symptoms of ADHD.
    

Detailed description: 
      Background:

      Many children with ADHD have, beside the main symptoms hyperactivity, impulsivity and a lack
      of ability to maintain attention, difficulties with social interaction. This is a burden in
      the childrens relationship towards parents, peers and teachers and thereby influencing their
      performances in school. Many children with ADHD find great help in receiving medical
      treatment, which has a good effect on the children's problems with hyperactivity, impulsivity
      and lacking attention. However, social interaction problems will probably not be set right
      due to medication alone. Several studies have shown that social skills training can help
      children with ADHD in their social interactions. It is also an interesting issue to further
      investigate treatment effect in relation to the ADHD-children's attachment competences, as
      one must assume that differences in attachment competences may influence the children's
      relationship and social interaction problems.

      The research intervention:

      Social skills training will consist of 8 weeks of group treatment with weekly sessions of one
      and a half hours and includes role play, exercises and games as well as home work which will
      include the parents. At the same time the parents are participating in parental training
      groups,that will focus on supporting the children's social training. Both the children and
      the parental groups are lead by two group therapists. The intervention will be additional to
      the received standard treatment.

      Control treatment:

      The standard treatment consists of medical treatment, briefing, consulting and supporting
      conversations with a focus on securing compliance to the treatments´ and on aiding children
      and their families with the difficulties arising with the children's illness. Furthermore the
      parents participate in parental groups three times during the 8 weeks in which the experiment
      takes place. This group lasts 2 hours and is managed by two nurses who are attached to the
      ADHD- treatment group.

      Method:

      Children in the age of 8-12 years with a diagnosis of ADHD are randomised to either the
      combination standard treatment, social skills training with parental training or to standard
      treatment. The sample size calculation shows that 52 patients must be included in the trial
      to show a 4 point difference in the primary outcome. The examinations of the children will
      take place at the baseline and after three and six months.

      Experimental hypotheses

        1. There is significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment in relation to the children's social
           competences.

           Measures: sub index 'Social Problems' from Conners CBRS and the sub index 'Peer
           Relations' from Conners 3.

        2. There is significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment in relation to
           hyperactivity/impulsivity problems.

           Measured by: sub index 'Hyperactivity/Impulsivity' from Conners 3.

        3. There is significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment in relation to the amount of
           children's aggressive behaviour and the children's emotional distress.

           Measures: sub indexes from Conners CBRS: 'Aggressive Behaviour' and 'Emotional
           distress'.

        4. There is significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment in relation to the childrens academic
           performance and executive functioning.

           Measures: sub indexes 'Academic Difficulties' from Conners CBRS and 'Executive
           Functioning' from Conners 3.

        5. There is significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment in relation to the children's social
           competences and symptoms of ADHD in relation to the different competences of attachment.

           Measured by: CAI- Children Attachment Interview.

        6. There is significant difference between experimental and standard treatment 6 months
           after start of treatment, as reflected in positive changes in the childrens attachment
           skills or an improvement in the categories; emotional openness, balance of positivity /
           negativity to attachment figure/s, idealisation of attachment figure/s, dismissal and/or
           derogation of attachment, the ability of conflict resolution, disorganisation and
           coherence of the narrative description.

           Measured by: CAI- Children Attachment Interview

        7. There is significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment in relation to the children's social
           competences and symptoms of ADHD in relation to the parent's amount of ADHD symptoms.

      Measured by: ASRS Symptom Checklist.

      Null hypothesis

        -  There is no significant difference between the clinical effect of the combination social
           skills training, parental training and standard treatment versus standard treatment 3
           and 6 months after the beginning of the treatment.

        -  There is no difference in the effect in one or the other treatment if the children's
           different forms of attachment styles are considered

        -  There is no difference in the effect in one or the other treatment if the children's
           parents ADHD symptoms are considered There is no difference 6 month after the beginning
           of the treatment in the effect in one or the other treatment if the childrens attachment
           skills or the undercategories are considered 6 month after the beginning of the
           treatment.
    

Intervention name(s): Social skills training, parental tr. and standard tr.; Standard treatment
Intervention type(s): Behavioral; Other
Intervention description(s): Social skills training will consist of 8 weeks of group treatment with weekly sessions of one and a half hours and includes role play, exercises and games as well as home work which will include the parents. At the same time the parents are participating in parental training groups,that will focus on supporting the children's social training. Both the children and the parental groups are lead by two group therapists. The intervention will be additional to the received standard treatment.; The standard treatment consists of medical treatment, briefing, consulting and supporting conversations with a focus on securing compliance to the treatments´ and on aiding children and their families with the difficulties arising with the children's illness. Furthermore the parents participate in parental groups three times during the 8 weeks in which the experiment takes place. This group lasts 2 hours and is managed by two nurses who are attached to the ADHD- treatment group.
Other intervention name(s): Psychosocial treatment.; Behavioral treatment.; Treatment as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social skills training for children with ADHD; Children with ADHD