Børnepsykiatrisk Ambulatorium, Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland
Holbæk, 4300, Denmark
NCT Number: NCT00937469
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.
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Notify Me8 year–13 year
All sexes
Interventional
Not applicable
Holbæk, 4300, Denmark
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
Measures: sub index 'Social Problems' from Conners CBRS and the sub index 'Peer Relations' from Conners 3.
Measured by: sub index 'Hyperactivity/Impulsivity' from Conners 3.
Measures: sub indexes from Conners CBRS: 'Aggressive Behaviour' and 'Emotional distress'.
Measures: sub indexes 'Academic Difficulties' from Conners CBRS and 'Executive Functioning' from Conners 3.
Measured by: CAI- Children Attachment Interview.
Measured by: CAI- Children Attachment Interview
Measured by: ASRS Symptom Checklist.
Null hypothesis
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with the following diagnoses according to DSM IV:
295.30(Paranoid type) 295.10(Disorganized type) 295.20(Catatonic type) 295.90(Undifferentiated type) 295.60(Residual type) 295.70(Schizoaffective Disorder) 297.1(Delusional Disorder) 298.8(Brief Psychotic Disorder) 297.3(Shared Psychotic Disorder) 298.9(Psychotic Disorder Not Otherwise Specified)
299.00 (Autistic Disorder) 299.10 (Childhood Disintegrative Disorder) 299.80 (Asperger´s Disorder) or a cut of score on both the SCQ questionnaires >15.
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.
Other names: Psychosocial treatment., Behavioral 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 names: Treatment as usual.
Time frame: 3 month
Time frame: 6 month
Time frame: 3 months
Time frame: 3 months
Time frame: 3 month
Time frame: 3 month
Time frame: 6 month
Time frame: 6 month
Time frame: 6 month
Time frame: 6 month
Time frame: 6 month
Time frame: 3 month
Time frame: 6 month
Region Zealand
Other
Social Skills Training and Standard Treatment Versus Standard Treatment of Children With ADHD - Attention Deficit Hyperactivity Disorder. Attachment Problems Among Children With ADHD
Acronym: SOSTRA-ADHD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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