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Clinical Trials/NCT00937469
NCT00937469CompletedNot Applicable

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

Region Zealand2 sites in 1 country55 target enrollmentStarted: August 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
55
Locations
2
Primary Endpoint
ADHD core symptoms: measured by Conners 3 index: 'Hyperactivity- Impulsivity Scale' (teacher rated.)

Study Overview

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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to 13 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.
  • 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:
  • 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 >
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 6 month

Secondary Outcomes

  • Aggressive behaviour: measured by Conners CBRS; subscale: 'Aggressive Behaviour Scale' (teacher rated).(6 month)
  • Emotional distress: measured by Conners CBRS: subscale: 'Emotional Distress Scale' (teacher rated).(6 month)
  • Executiv functioning: measured by Conners 3 index: 'Executive Functioning' (teacher rated).(6 month)
  • Academic difficulties: measured by Conners CBRS index: 'Academic Difficulties' (teacher rated).(6 month)
  • Attachment: measured by Children Attachment Interview.(6 month)
  • Social Skills: measured by Conners CBRS subscale: 'Social Problems Scale'( teacher rated) and by Conners 3 subscale: 'Peer Relations Scale'. (teacher rated).(6 month)

Investigators

Sponsor
Region Zealand
Sponsor Class
Other

Study Sites (2)

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