Clinical trial NCT01660425: Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
Official title: Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit-/Hyperactivity Disorder
Keywords: Attention deficit-/hyperactivity disorder
parenting enhancement training
guided self-help
methylphenidate
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2012-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
timeFrame: 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
timeFrame: baseline, six months, 12 months; 16 months (control group)
measure: Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
timeFrame: baseline, six months, 12 months; 16 months (control group)
measure: Change in Individual Problem Checklist (IPC), parent rating
timeFrame: baseline, six months, 12 months; 16 months
measure: Change in Satisfaction with Medication Scale (SAMS), parent rating
timeFrame: baseline, six months, 12 months; 16 months (control group)
measure: Change in "Compliance Scale", parent rating
timeFrame: baseline, six months, 12 months; 16 months (control group)
measure: Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)
timeFrame: baseline, six months, 12 months; 16 months (control group)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Manfred Doepfner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dose C, Hautmann C, Buerger M, Schuermann S, Woitecki K, Doepfner M. Telephone-assisted self-help for parents of children with attention-deficit/hyperactivity disorder who have residual functional impairment despite methylphenidate treatment: a randomized controlled trial. J Child Psychol Psychiatry. 2017 Jun;58(6):682-690. doi: 10.1111/jcpp.12661. Epub 2016 Nov 23.