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Social Skills Training and Standard Treatment Versus Standard Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD) (SOSTRA-ADHD)
This study has been completed.

First Received on July 10, 2009.   Last Updated on August 4, 2011   History of Changes
Sponsor: Region Sealand
Collaborators: Region Sealand University Hospital(RESUS).
Copenhagen Trial Unit, Center for Clinical Intervention Research
Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland.
Psykiatrisk Forskningsenhed, Region Sjælland.
Information provided by: Region Sealand
ClinicalTrials.gov Identifier: NCT00937469
  Purpose

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.


Condition Intervention
ADHD
Attention Deficit Hyperactivity Disorder
 Behavioral: Social skills training, parental tr. and standard tr.
Other: Standard treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
U.S. FDA Resources

Further study details as provided by Region Sealand:

Primary Outcome Measures:
  • ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated). [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated). [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Attachment: measured by Children Attachment Interview. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: August 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social sk. tr., parent tr.,standard tr. Behavioral: Social skills training, parental tr. and standard tr.
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.
Active Comparator: Standard treatment Other: 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 Name: Treatment as usual.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The parents should be interested in taking part in parental groups in Børnepsykiatrisk Ambulatorium in Holbæk.
  2. 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.
  3. The patients´ parents must give informed consent to participate in the trial.
  4. The children must be between 8-12 years old by the time of the start of the assessment.
  5. Both boys and girls can participate.
  6. Children with a total verbal or nonverbal IQ>80 according to the WISC III.
  7. The children must fulfil research criteria for the diagnosis ADHD according to DSM IV (1994): 314.00, 314.01,314.02 or 314.9.
  8. The parents must be prepared to the fact that their children have to receive medical treatment for their ADHD.

Exclusion Criteria:

Patients with the following diagnoses according to DSM IV:

  1. 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)

  2. 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.

  3. Violent and criminal youngsters.
  4. Children with a total verbal or nonverbal IQ<80 according to WISC III
  5. Strong resistance from the child against participating.
  6. Previous started medical treatment for ADHD.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937469

Locations
Denmark
Børnepsykiatrisk Ambulatorium, Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland
Holbæk, Denmark, 4300
Sponsors and Collaborators
Region Sealand
Region Sealand University Hospital(RESUS).
Copenhagen Trial Unit, Center for Clinical Intervention Research
Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland.
Psykiatrisk Forskningsenhed, Region Sjælland.
Investigators
Study Director: Jesper Pedersen, MD,Phd. Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
CTU- Copenhagen Trial Unit  This link exits the ClinicalTrials.gov site

No publications provided by Region Sealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Storebø 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.

Responsible Party: Ole Jakob Storebø, Psychologist. MS, Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland
ClinicalTrials.gov Identifier: NCT00937469     History of Changes
Other Study ID Numbers: SOSTRA-BU/REGIONSJ.1, Ethics C. no. SJ-85, Data p. agency no. DO50892
Study First Received: July 10, 2009
Last Updated: August 4, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Region Sealand:
Social skills training for children with ADHD
Children with ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012



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