Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-29 @ 3:59 AM
Study NCT ID:
NCT00937469
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2009-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Skills Training and Standard Treatment Versus Standard Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Region Zealand
Organization:
Study Overview
Official Title:
Social Skills Training and Standard Treatment Versus Standard Treatment of Children With ADHD - Attention Deficit Hyperactivity Disorder. Attachment Problems Among Children With ADHD
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOSTRA-ADHD
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: