Social Skills Training and Standard Treatment Versus Standard Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00937469 | Completed DMC

• 3 other identifiers: SOSTRA-BU/REGIONSJ.1Ethics C. no. SJ-85Data p. agency no. DO50892
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder

Keywords

Social skills training for children with ADHD; Children with ADHD

Outcome Measures

Primary Outcomes (2)

• ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)

  3 month

• ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)

  6 month

Secondary Outcomes (11)

• Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated).

  3 months

• Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated).

  3 months

• Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated).

  3 month

• Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated).

  3 month

• Attachment: measured by Children Attachment Interview.

  6 month

Study Arms (2)

Social sk. tr., parent tr.,standard tr.

EXPERIMENTAL

Behavioral: Social skills training, parental tr. and standard tr.

Standard treatment

ACTIVE COMPARATOR

Other: Standard treatment

Interventions

Social skills training, parental tr. and standard tr. BEHAVIORAL

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.

Also known as: Psychosocial treatment., Behavioral treatment.

Social sk. tr., parent tr.,standard tr.

Standard treatment OTHER

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.

Also known as: Treatment as usual.

Standard treatment

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients with the following diagnoses according to DSM IV:
• Schizophrenia:
• (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:
• (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.
• 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.

Sponsors & Collaborators

• Region Zealand: lead
• Zealand University Hospital: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Region Sjælland: collaborator

Study Sites (1)

Børnepsykiatrisk Ambulatorium, Børne- og Ungdomspsykiatrisk Afdeling, Region Sjælland

Holbæk, 4300, Denmark

Location

Related Publications (2)

• 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.

  PMID: 22745657 DERIVED

• Storebo 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.

  PMID: 21255399 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Behavior Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jesper Pedersen, MD,Phd.

  Region Sjælland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: August 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2011-07

Locations

DK (1)