Overview

This trial is active, not recruiting.

Condition attention deficit-/hyperactivity disorder
Treatment enhancement with psychosocial intervention
Sponsor University of Cologne
Collaborator Shire
Start date May 2012
End date December 2014
Trial size 100 participants
Trial identifier NCT01660425, 2486738, ADHD-TEAM-02

Summary

The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
In the first twelve months of intervention the children receive treatment as usual with MPH and do not get any further intervention. Afterwards, the families get the opportunity to take part in the program which is then conducted for a duration of four months. Measurements are performed at the beginning of the program, after six moths, after 12 months and additionally after 16 months.
(Active Comparator)
Parenting Enhancement Training as a form of psychosocial intervention is a guided program. Parents get the opportunity to discuss written information with a therapist in 20 minutes telephone calls. 14 telephone calls are offered. The whole intervention lasts for a period of one year. Booklets are mailed via post within the first 4 months. First 9 telephone calls are also within the first 4 months, usually every two weeks. Telephone calls 10 and 11 are within 5th or 6th month, telephone calls 12 to 14 are within 7th to 12th month with a two monthly time period in between.
enhancement with psychosocial intervention

Primary Outcomes

Measure
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)

Secondary Outcomes

Measure
Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
Change in Individual Problem Checklist (IPC), parent rating
time frame: baseline, six months, 12 months; 16 months
Change in Satisfaction with Medication Scale (SAMS), parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
Change in "Compliance Scale", parent rating
time frame: baseline, six months, 12 months; 16 months (control group)
Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)
time frame: baseline, six months, 12 months; 16 months (control group)

Eligibility Criteria

Male or female participants from 6 years up to 12 years old.

Inclusion Criteria: - The child attends school and is aged 6 to 12 - Primary diagnosis of ADHD - Medication with methylphenidate in stable doses for at least two months - Currently, no change of medication is planned - The parents are motivated to participate in the parenting enhancement training - The parents have a command of written and spoken German - Psychosocial impairment measured with WFIRS-P Exclusion criteria: - the family takes presumably part in psychotherapy with an intensive parenting training component during the duration of the intervention

Additional Information

Official title Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support
Principal investigator Manfred Doepfner, PhD
Description The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) already medicated with methylphenidate (MPH). This particular PET was developed at the Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne and has already been evaluated in several studies. MPH treatment has been proven to be efficacious in the reduction of ADHD symptoms. However, despite optimal titration a substantial percentage of children still suffer from residual symptoms and impairment in psychosocial functioning. Therefore, there is still room for improvement in satisfaction with medication. Moreover, a substantial rate of patients with good treatment effects fails to comply with medication during the course of treatment. This parenting enhancement training (PET) mainly conducted via written materials and telephone support will be introduced in patients already treated with MPH. Effects are expected on symptoms of ADHD as well as on comorbid oppositional symptoms. Further outcome parameters are satisfaction with medication and medication compliance of MPH treatment, psychosocial functioning as well as parenting skills. Parenting skills are a main focus of the PET and ADHD symptoms shall be improved through improving parenting skills. Besides focusing on symptoms, recent research often focuses on improvement of quality of life and impairment in psychosocial functioning (e. g. family, school, leisure time) as well. Not only suffer patients from the main symptoms. Many patients suffer as well from the symptoms' consequences, which is often an overall impairment. Satisfaction with medication and medication compliance are fundamental conditions for the success of a long term medical therapy. However, many studies show a lack of compliance.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of Cologne.