Attention-Deficit/Hyperactivity DisorderNCT01351246
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
A study testing CBT Based Self-help Workbook + Counseling Telephone in people with Attention-Deficit/Hyperactivity Disorder, run by University of Cologne at 1 site in Germany.
Trial summary
Cognitive-behavioral based guided self-help for parents of children with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. 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?
- CBT Based Self-help Workbook + Counseling Telephone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Mar 2014
- 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
- Child diagnosis of ADHD
Who cannot join
- Language or reading difficulties of participating parent
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, 50931
About this study
Official title: Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD): A Feasibility and Effectiveness Study
Cognitive-behavioral based guided self-help for parents of children with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.
Read the detailed description
Self-directed interventions may overcome many of the barriers associated with accessing face-to-face services, as there is lowered stigma and significantly reduced or eliminated cost, transport, and timing difficulties. Families can complete self-directed programs at home, in their own time and at their own pace. Furthermore self-administered programs are often very cost-effective and their use can ease the financial burden of mental health of the community. These parenting programs can be particularly effective by reaching the populace. Moreover in primary care settings where financial resources, time and expertise might be lacking to provide behavioral interventions, self-directed programs might be a promising tool for disseminating effective parenting interventions more widely.
Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is thought to meet the specific need of the person to be treated and reading is used as the therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of guided self-help provides patients (or parents) with written instructions as well as therapeutic contacts at regular intervals. During these contacts, problems and questions can be discussed to give further support. Self-help interventions have already proven to be effective for adults with anxiety or affective disorders as well as for depressive adolescents. However there has only been little research concerning the reduction of children's behaviour problems through parental self-help programs under minimal contact conditions.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- CBT Based Self-help Workbook + Counseling Telephone
- Keywords
- Program Evaluation, ADHD
- 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.
CBT Based Self-help Workbook + Counseling TelephoneBehavioural
Also called Guided self help, behavioral treatment
Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation and is based on the therapy manual "Therapy program for children with hyperactive and oppositional problem behavior THOP" (Döpfner, Schürmann, \& Frölich, 2007) and the parent self-help book "Wackelpeter and Trotzkopf: Help for parents of children with hyperkinetic and oppositional behavior" (Döpfner, Schürmann, \& Lehmkuhl, 2006). Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: CBT Based Self-help Workbook + Counseling Telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008
Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.
Measured: one year
Secondary outcomes (2)
Strengths & Difficulties Questionnaire (SDQ)
Questionnaire assesses comorbid symptoms. Informant is the participating parent.
Measured: 1 year
Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)
Questionnaire assesses child´s quality of life. Informant is participating parent.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2010
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Manfred Doepfner, University of Cologne
- Investigators
- Manfred Döpfner, PhD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351246
- Sponsor's protocol ID
- ADHD-TEAM-01
- Status last verified
- Apr 2014
- First submitted
- 2 May 2011
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD): A Feasibility and Effectiveness Study
- ClinicalTrials.gov ID
- NCT01351246
- Acronym / sponsor ID
- ADHD-TEAM-01
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- Program Evaluation, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- May 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 May 2011 (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.
Cognitive-behavioral based guided self-help for parents of children with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.
Detailed description
Self-directed interventions may overcome many of the barriers associated with accessing face-to-face services, as there is lowered stigma and significantly reduced or eliminated cost, transport, and timing difficulties. Families can complete self-directed programs at home, in their own time and at their own pace. Furthermore self-administered programs are often very cost-effective and their use can ease the financial burden of mental health of the community. These parenting programs can be particularly effective by reaching the populace. Moreover in primary care settings where financial resources, time and expertise might be lacking to provide behavioral interventions, self-directed programs might be a promising tool for disseminating effective parenting interventions more widely.
Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is thought to meet the specific need of the person to be treated and reading is used as the therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of guided self-help provides patients (or parents) with written instructions as well as therapeutic contacts at regular intervals. During these contacts, problems and questions can be discussed to give further support. Self-help interventions have already proven to be effective for adults with anxiety or affective disorders as well as for depressive adolescents. However there has only been little research concerning the reduction of children's behaviour problems through parental self-help programs under minimal contact conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CBT Based Self-help Workbook + Counseling Telephone |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child diagnosis of ADHD
Key exclusion criteria (1 listed)
- Language or reading difficulties of participating parent
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 |
|---|---|---|
| CBT Based Self-help Workbook + Counseling TelephoneAlso: Guided self help, behavioral treatmentOver a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation and is based on the therapy manual "Therapy program for children with hyperactive and oppositional problem behavior THOP" (Döpfner, Schürmann, \& Frölich, 2007) and the parent self-help book "Wackelpeter and Trotzkopf: Help for parents of children with hyperkinetic and oppositional behavior" (Döpfner, Schürmann, \& Lehmkuhl, 2006). Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet. | Behavioural | Intervention |
Primary outcome
Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008
Time frame: one year
Questionnaire assesses the diagnostic criteria of DSM-IV and ICD-10 for ADHD. Informant is participating parent.
2 secondary outcomes
Strengths & Difficulties Questionnaire (SDQ)
Time frame: 1 year
Quality of Life Questionnaire KINDL (Ravens-Sieberer & Bullinger, 2000)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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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 Döpfner, 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 CBT Based Self-help Workbook + Counseling Telephone 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 1 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: finished, as of the sponsor's last update on 15 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total score of the Symptom Checklist Attention-Deficit/Hyperactivity Disorder (SCL-ADHD, Döpfner, Görtz-Dorten & Lehmkuhl, 2008 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2014.