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Social Skills Training and Standard Treatment Versus Standard Treatment of Children With ADHD - Attention Deficit Hyperactivity Disorder. Attachment Problems Among Children With ADHD

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: 
Children with ADHD.
Intervention: 
Social skills training
Study Type: 
Intervention
Study Design: 

 

The trial is a randomised two-armed, parallel group, assessor-blinded trial. Children aged 8–12 years with a diagnosis of ADHD are randomised to social-skills training with parental training plus standard treatment vs. standard treatment alone. The sample size calculation shows that 52 children must be included in the trial to show a 4-point difference in the primary outcome on the Conners rating scale subindex hyperactivity between the intervention group and the control group. The outcomes will be examined three and six months after randomisation.
Primary Outcome Measures: 

 

1.      Social skills: measured by Conners´ CBRS subscale 'social problems' (teacher rated) and by Conners´ 3 subscale: 'peer relations’(teacher rated).
2.      ADHD symptoms: measured by Conners´ 3 subscale: 'hyperactivity-impulsivity' (teacher rated).
 
Secondary Outcome Measures: 

Secondary outcome

1.      Aggressive behaviour: measured by Conners´ CBRS; subscale: 'aggressive behavior' (teacher rated).
2.      Emotional distress: measured by Conners´ CBRS: subscale: 'emotional distress' (teacher rated).
3.      Executive functions: measured by Conners´ 3: subscale: 'executive functioning' (teacher rated).
4.      Academic performance: measured by Conners´ CBRS: subscale: 'academic performances' (teacher rated).
5.      Overall psychopathology: measured by Conners´ CBRS; T-score (teacher rated).
6.      Overall ADHD: measured by Conners´ 3; T-score (teacher rated).
Tertiary outcome
1.      Social skills and symptoms of ADHD measured in relation to Attachment: measured by: Children Attachment Interview.
2.      Social skills and symptoms of ADHD measured in relation to Parental ADHD symptoms: measured by: ASRS Symptom Checklist.
 
 
Enrollment: 
Recruiting
Study Start Date: 
01.08.2009
Primary Completion Date: 
01.07.2011
Groups: 

Social skills training, parental training and standard treatment versus standard treatment

Assigned Interventions: 

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.

Ages of Eligibility: 
8-12
Gender: 
both
Inclusion 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: 

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: 

Contact:   Ole Jakob Storebø, psychol., MS
    Telephone:   59484735
    Email:   ojst@regionsjaelland.dk
Contact Backup:   Jesper Pedersen, MD,Phd.
    Telephone:   59484730
    Email:   jpee@regionsjaelland.dk
Investigator:   Erik Simonsen, MD.
    Role: Sub-Investigator
Recruitment Status:   Recruiting  

Locations: 

Facility:     Børnepsykiatrisk Ambulatorium, Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland
  Holbæk, Denmark
 

Sponsors & Collaborators: 

Region Sealand University Hospital(RESUS).
CTU- Copenhagen Trial Unit, Center for Clinical Intervention Research.
Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland.
Psykiatrisk Forskningsenhed, Region Sjælland.

Investigators: 

Jesper Pedersen, MD,Phd.
Study Director
Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland.

Telephone:   59484730

Email:   jpee@regionsjaelland.dk

Ole Jakob Storebø,Psychologist. MS

primery investigator

Telephone: 59484735

Email: ojst

 

Responsible Party: 
Name/Official Title: Ole Jakob Storebø, Psychologist. MS
Study ID Numbers: 
Approval Status: Approved Approval Number: Sj-85
Health Authority: 
Region Sjaellands Ethics Committee