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Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

Primary Purpose

Attention Deficit-/Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Enhancement with psychosocial intervention
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit-/Hyperactivity Disorder focused on measuring Attention deficit-/hyperactivity disorder, parenting enhancement training, guided self-help, methylphenidate

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

treatment as usual with MPH

Psychosocial intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.

Secondary Outcome Measures

Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent.
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
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.
Change in Individual Problem Checklist (IPC), parent rating
The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
Change in Satisfaction with Medication Scale (SAMS), parent rating
The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication.
Change in "Compliance Scale", parent rating
Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient
Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)
Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication

Full Information

First Posted
August 6, 2012
Last Updated
March 12, 2014
Sponsor
University of Cologne
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01660425
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
Collaborators
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit-/Hyperactivity Disorder
Keywords
Attention deficit-/hyperactivity disorder, parenting enhancement training, guided self-help, methylphenidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment as usual with MPH
Arm Type
No Intervention
Arm Description
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.
Arm Title
Psychosocial intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhancement with psychosocial intervention
Primary Outcome Measure Information:
Title
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating
Description
The WFIRS-P is used for the assessment of psychosocial functioning of children diagnosed with ADHD.
Time Frame
baseline, six months, 12 months; 16 months (control group)
Secondary Outcome Measure Information:
Title
Change in Symptom Checklist for Attention Deficit/Hyperactivity Disorder (FBB-ADHS), parent rating
Description
The FBB-ADHS is used to assess symptoms of ADHD according to DSM-IV and ICD-10 rated by a parent.
Time Frame
baseline, six months, 12 months; 16 months (control group)
Title
Change in Symptom Checklist for Oppositional Defiant and Conduct Disorder (FBB-SSV), parent rating
Description
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.
Time Frame
baseline, six months, 12 months; 16 months (control group)
Title
Change in Individual Problem Checklist (IPC), parent rating
Description
The IPC assesses individual problems as defined together with the parents. It represents the individual problems which were aimed to reduce with the treatment.
Time Frame
baseline, six months, 12 months; 16 months
Title
Change in Satisfaction with Medication Scale (SAMS), parent rating
Description
The SAMS is used to assess parents' satisfaction with the medication of their child as well as with the effects of medication.
Time Frame
baseline, six months, 12 months; 16 months (control group)
Title
Change in "Compliance Scale", parent rating
Description
Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient
Time Frame
baseline, six months, 12 months; 16 months (control group)
Title
Questionnaire to assess adverse effects of medication, taken from the Day Profile of ADHD Symptoms (DAYAS)
Description
Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication
Time Frame
baseline, six months, 12 months; 16 months (control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Doepfner, PhD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27878809
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.
Results Reference
derived

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Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support

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