ADHDSOSTRA-ADHDNCT00937469
Social Skills Training and Standard Treatment Versus Standard Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Social skills training, parental tr. and standard tr. and Standard treatment in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Region Zealand at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Social skills training, parental tr. and standard tr. and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The parents should be interested in taking part in parental groups in Børnepsykiatrisk Ambulatorium in Holbæk.
- The patients (and the parents) must understand and speak Danish language to an extent where a translator is not needed in order to be able to complete the assessment and the treatment.
- The patients´ parents must give informed consent to participate in the trial.
- The children must be between 8-12 years old by the time of the start of the assessment.
- Both boys and girls can participate.
- Children with a total verbal or nonverbal IQ>80 according to the WISC III.
- The children must fulfil research criteria for the diagnosis ADHD according to DSM IV (1994): 314.00, 314.01,314.02 or 314.9.
- The parents must be prepared to the fact that their children have to receive medical treatment for their ADHD.
Who cannot join
- Patients with the following diagnoses according to DSM IV:
- Schizophrenia:
- 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)
- Children with autism according to DSM IV:
- 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.
- Violent and criminal youngsters.
Show all 9Show fewer
- Children with a total verbal or nonverbal IQ<80 according to WISC III
- Strong resistance from the child against participating.
- Previous started medical treatment for ADHD.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Børnepsykiatrisk Ambulatorium, Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland
Holbæk, 4300
About this study
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
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.
Read the 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
- 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.
- 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.
- 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'.
- 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.
- 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.
- 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
- 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.
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Being tested
- Social skills training, parental tr. and standard tr., Standard treatment
- Keywords
- Social skills training for children with ADHD, Children with ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social skills training, parental tr. and standard tr.Behavioural
Also called Psychosocial treatment., Behavioral treatment.
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.
Standard treatmentOther
Also called Treatment as usual.
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.
| Study group | Role | What they receive |
|---|---|---|
| Social sk. tr., parent tr.,standard tr. | Experimental | Not described Receives: Behavioral: Social skills training, parental tr. and standard tr. |
| Standard treatment | Active comparator | Not described Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)
Measured: 3 month
ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)
Measured: 6 month
Secondary outcomes (11)
Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated).
Measured: 3 months
Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated).
Measured: 3 months
Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated).
Measured: 3 month
Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated).
Measured: 3 month
Attachment: measured by Children Attachment Interview.
Measured: 6 month
Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated).
Measured: 6 month
Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated).
Measured: 6 month
Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated).
Measured: 6 month
Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated).
Measured: 6 month
Social Skills: measured by Conners CBRS subscale: 'Social Problems Scale'( teacher rated) and by Conners 3 subscale: 'Peer Relations Scale'. (teacher rated).
Measured: 3 month
Social Skills: measured by Conners CBRS subscale: 'Social Problems Scale'( teacher rated) and by Conners 3 subscale: 'Peer Relations Scale'. (teacher rated).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, Region Sjælland
- Investigators
- Jesper Pedersen, MD,Phd., Study director, Region Sjælland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937469
- Sponsor's protocol ID
- SOSTRA-BU/REGIONSJ.1
- Other IDs
- Ethics C. no. SJ-85, Data p. agency no. DO50892
- Acronym
- SOSTRA-ADHD
- Status last verified
- Jul 2011
- First submitted
- 10 Jul 2009
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Storebo OJ, Gluud C, Winkel P, Simonsen E. Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial. PLoS One. 2012;7(6):e37280. doi: 10.1371/journal.pone.0037280. Epub 2012 Jun 20.
PubMed 22745657Storebo OJ, Pedersen J, Skoog M, Thomsen PH, Winkel P, Gluud C, Simonsen E. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol. Trials. 2011 Jan 21;12:18. doi: 10.1186/1745-6215-12-18.
PubMed 21255399
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00937469
- Acronym / sponsor ID
- SOSTRA-ADHD / SOSTRA-BU/REGIONSJ.1
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Keywords
- Social skills training for children with ADHD, Children with ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, Region Sjælland
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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'.
- 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.
- 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.
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social sk. tr., parent tr.,standard tr. | Experimental | Behavioral: Social skills training, parental tr. and standard tr. |
| Standard treatment | Active comparator | Other: Standard treatment |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The parents should be interested in taking part in parental groups in Børnepsykiatrisk Ambulatorium in Holbæk.
- The patients (and the parents) must understand and speak Danish language to an extent where a translator is not needed in order to be able to complete the assessment and the treatment.
- The patients´ parents must give informed consent to participate in the trial.
- The children must be between 8-12 years old by the time of the start of the assessment.
- Both boys and girls can participate.
Key exclusion criteria (9 listed)
- Schizophrenia:
- 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)
- Children with autism according to DSM IV:
- 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.
- Violent and criminal youngsters.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social skills training, parental tr. and standard tr.Also: Psychosocial treatment., Behavioral treatment.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. | Behavioural | Social sk. tr., parent tr.,standard tr. |
| Standard treatmentAlso: Treatment as usual.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 | Standard treatment |
Primary outcome
ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)
Time frame: 3 month
ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)
Time frame: 6 month
11 secondary outcomes
Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated).
Time frame: 3 months
Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated).
Time frame: 3 months
Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated).
Time frame: 3 month
Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated).
Time frame: 3 month
Attachment: measured by Children Attachment Interview.
Time frame: 6 month
Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated).
Time frame: 6 month
Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated).
Time frame: 6 month
Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated).
Time frame: 6 month
Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated).
Time frame: 6 month
Social Skills: measured by Conners CBRS subscale: 'Social Problems Scale'( teacher rated) and by Conners 3 subscale: 'Peer Relations Scale'. (teacher rated).
Time frame: 3 month
Social Skills: measured by Conners CBRS subscale: 'Social Problems Scale'( teacher rated) and by Conners 3 subscale: 'Peer Relations Scale'. (teacher rated).
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Derived from this study: PubMed 22745657Storebo OJ, Gluud C, Winkel P, Simonsen E. Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial. PLoS One. 2012;7(6):e37280. doi: 10.1371/journal.pone.0037280. Epub 2012 Jun 20.
- Derived from this study: PubMed 21255399Storebo OJ, Pedersen J, Skoog M, Thomsen PH, Winkel P, Gluud C, Simonsen E. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol. Trials. 2011 Jan 21;12:18. doi: 10.1186/1745-6215-12-18.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper Pedersen, MD,Phd. study director
Region Sjælland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social skills training, parental tr. and standard tr. and Standard treatment in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Region Zealand at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.