Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

March 12, 2014 updated by: Manfred Doepfner, University of Cologne

Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: treatment as usual with MPH
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: Psychosocial intervention
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.
Behavioral: Enhancement with psychosocial intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
Time Frame: baseline, six months, 12 months; 16 months (control group)
The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.
baseline, six months, 12 months; 16 months (control group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
Time Frame: baseline, six months, 12 months; 16 months (control group)
The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent.
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)
The Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV) is used to assess symptoms of ODD and some of the symptoms of Conduct Disorders according to ICD-10 and DSM-IV.
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
The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
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)
The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication.
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)
Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient
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)
Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication
baseline, six months, 12 months; 16 months (control group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Shire

Investigators

  • Principal Investigator: Manfred Doepfner, PhD, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADHD-TEAM-02
  • 2486738 (Other Grant/Funding Number: Shire pharmaceutical development limited)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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