Attention Deficit/Hyperactivity DisorderPhase 1NCT00946582
The Therapeutic Effects of Barkley's Parenting Management Program for Taiwanese School-Aged Children With Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 1 study testing Barkley's parenting management program in people with Attention Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the therapeutic effects of Barkley's parenting management program for Taiwanese school-aged children with ADHD. The investigators hypothesized that Barkley's parenting management program might empower the parents' competence to manage their school-aged children's ADHD-related… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Barkley's parenting management program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2009to Apr 2010
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of 7-12 year-old aged children with ADHD and overall normal intelligence
Who cannot join
- Parents of children with comorbid autism spectrum disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yun-Lin Branch
Douliu, Yunlin County, 640
Shu-Tsen Liu, M.D, +88655323911 ext. 7108, zoe.green@msa.hinet.net
About this study
Official title: The Therapeutic Effects of Barkley's Parenting Management Program for Taiwanese School-aged Children With Attention Deficit/Hyperactivity Disorder
The purpose of this study is to explore the therapeutic effects of Barkley's parenting management program for Taiwanese school-aged children with ADHD. The investigators hypothesized that Barkley's parenting management program might empower the parents' competence to manage their school-aged children's ADHD-related disturbing behaviors as its previously-proven effects for parents and their preschool-aged children with ADHD.
Read the detailed description
Participants will be recruited from the child psychiatric clinics of NTUH-Yunlin branch and will include 30 school children with ADHD, their parents and teachers. The Kiddie-Schedule for Affective Disorders and Schizophrenia-epidemiology version will be adopted to confirm the diagnosis of ADHD. The child participants will received assessments of the Conner's Continuous Performance Test, and the Wechsler Intelligence Scale for Children-4th edition. We use ADHD symptoms, children't wellbeing, parent-child relationship, parent's competence and parenting stress as the outcome indices of therapeutic effects.Research instruments employed include CBCL, SNAP-IV, Parental Bonding Instrument, The Family Adaptability and Cohesion Evaluation Scale, Chinese Health Questionnaire, Parenting Stress Index, Short Form, Multidimensional student's life satisfaction scale and Nowicki-Strickland Locus of Control Scale for Children.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Barkley's parenting management program
- Keywords
- parenting management program, 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.
Barkley's parenting management programBehavioural
It is a parent training group to teach behavior therapy techniques to parents of children with ADHD. The group will contain about 10 parents of children with ADHD. It will be conducted 1.5 hour per session, one session per week, and 11 sessions totally.
What is being measured
The primary outcome is the main question the study is designed to answer.
SNAP-IV
Measured: pretest, before session 4, before session 8, posttest, 3 months after the program finished
Secondary outcomes (1)
Parenting Stress Index, Short Form
Measured: pretest, posttest, 3 months after the program finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shu-Tsen Liu, M.D, Study director, Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946582
- Sponsor's protocol ID
- 200904005R
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effects of Barkley's Parenting Management Program for Taiwanese School-aged Children With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00946582
- Acronym / sponsor ID
- 200904005R
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- parenting management program, ADHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 27 Jul 2009 (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 purpose of this study is to explore the therapeutic effects of Barkley's parenting management program for Taiwanese school-aged children with ADHD. The investigators hypothesized that Barkley's parenting management program might empower the parents' competence to manage their school-aged children's ADHD-related disturbing behaviors as its previously-proven effects for parents and their preschool-aged children with ADHD.
Detailed description
Participants will be recruited from the child psychiatric clinics of NTUH-Yunlin branch and will include 30 school children with ADHD, their parents and teachers. The Kiddie-Schedule for Affective Disorders and Schizophrenia-epidemiology version will be adopted to confirm the diagnosis of ADHD. The child participants will received assessments of the Conner's Continuous Performance Test, and the Wechsler Intelligence Scale for Children-4th edition. We use ADHD symptoms, children't wellbeing, parent-child relationship, parent's competence and parenting stress as the outcome indices of therapeutic effects.Research instruments employed include CBCL, SNAP-IV, Parental Bonding Instrument, The Family Adaptability and Cohesion Evaluation Scale, Chinese Health Questionnaire, Parenting Stress Index, Short Form, Multidimensional student's life satisfaction scale and Nowicki-Strickland Locus of Control Scale for Children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of 7-12 year-old aged children with ADHD and overall normal intelligence
Key exclusion criteria (1 listed)
- Parents of children with comorbid autism spectrum disorders
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 |
|---|---|---|
| Barkley's parenting management programIt is a parent training group to teach behavior therapy techniques to parents of children with ADHD. The group will contain about 10 parents of children with ADHD. It will be conducted 1.5 hour per session, one session per week, and 11 sessions totally. | Behavioural | – |
Primary outcome
SNAP-IV
Time frame: pretest, before session 4, before session 8, posttest, 3 months after the program finished
1 secondary outcome
Parenting Stress Index, Short Form
Time frame: pretest, posttest, 3 months after the program finished
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
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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.
Shu-Tsen Liu, M.D study director
Department of Psychiatry, National Taiwan University Hospital, Yun-Lin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Barkley's parenting management program in people with Attention Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 27 Jul 2009. 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 Taiwan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shu-Tsen Liu, M.D (+886-928106143, zoe.green@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNAP-IV (time frame: pretest, before session 4, before session 8, posttest, 3 months after the program finished). 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 27 Jul 2009.