Attention Deficit-/Hyperactivity DisorderNCT01660425
Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
A study testing Enhancement with psychosocial intervention in people with Attention Deficit-/Hyperactivity Disorder, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit-/Hyperactivity Disorder
- What is being tested?
- Enhancement with psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- the family takes presumably part in psychotherapy with an intensive parenting training component during the duration of the intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry and Psychotherapy at the University of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: 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.
Read the 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.
- Being tested
- Enhancement with psychosocial intervention
- Keywords
- Attention deficit-/hyperactivity disorder, parenting enhancement training, guided self-help, methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancement with psychosocial interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual with MPH | 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. |
| Psychosocial intervention | 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. Receives: Behavioral: Enhancement with psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, six months, 12 months; 16 months (control group)
Secondary outcomes (6)
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.
Measured: baseline, six months, 12 months; 16 months (control group)
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.
Measured: baseline, six months, 12 months; 16 months (control group)
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.
Measured: baseline, six months, 12 months; 16 months
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.
Measured: baseline, six months, 12 months; 16 months (control group)
Change in "Compliance Scale", parent rating
Newly developed parent questionnaire consisting of five items to assess the medication compliance of the patient
Measured: 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)
Subscale of the Day Profile of ADHD Symptoms (DAYAS) which assesses in 11 items the most frequent side effects of ADHD medication
Measured: baseline, six months, 12 months; 16 months (control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit-/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Manfred Doepfner, University of Cologne
- Investigators
- Manfred Doepfner, PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660425
- Sponsor's protocol ID
- ADHD-TEAM-02
- Other IDs
- 2486738
- Status last verified
- Mar 2014
- First submitted
- 6 Aug 2012
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27878809
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Psychosocial Functioning, Quality of Life, Satisfaction With Medication and Medication Compliance of Methylphenidate Treatment by Psychosocial Intervention and Support
- ClinicalTrials.gov ID
- NCT01660425
- Acronym / sponsor ID
- ADHD-TEAM-02
- Keywords
- Attention deficit-/hyperactivity disorder, parenting enhancement training, guided self-help, methylphenidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Shire
- Study start
- May 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment as usual with MPH | 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. |
| Psychosocial intervention | Active comparator | Behavioral: Enhancement with psychosocial interventionParenting 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- the family takes presumably part in psychotherapy with an intensive parenting training component during the duration of the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhancement with psychosocial intervention | Behavioural | Psychosocial intervention |
Primary outcome
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.
6 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Derived from this study: PubMed 27878809Dose 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Doepfner, PhD principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancement with psychosocial intervention in people with Attention Deficit-/Hyperactivity Disorder, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weiss Functional Impairment Rating Scale (WFIRS-P), parent rating (time frame: baseline, six months, 12 months; 16 months (control group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01660425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.