Attention-deficit/Hyperactivity DisorderNCT00491361
Chinese Versions of the Swanson, Nolan, and Pelham, Version IV (SNAP-IV) Scale and Strengths Difficulties Questionnaire.
An observational study of Attention-deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and society. The diagnosis of ADHD is mainly based on clinical interview of parents and children with assistance of teachers' reports. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- How many people
- 3,600 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Jul 2006
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: School-based subjects \& Clinical subjects with ADHD
Who may be able to join
- School-based subjects: around 3600 grade 1 to grade 8 students aged 6-16 from four sites in Taiwan and their parents (n = 7200)
- Clinical subjects with ADHD: children and adolescents ages 6-16, who are diagnosed with ADHD, IQ >70, parents and teachers consent to completion of questionnaires.
Who cannot join
- Clinical subjects with ADHD: those who are comorbid with pervasive developmental disorder and/or mental retardation or other severe psychiatric disorders. Oppositional defiant disorder and conduct disorder are not excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, National Taiwan University Hospital
Taipei, 10002
About this study
Official title: Psychometric Study of the Chinese Versions of the Swanson, Nolan, and Pelham, Version IV (SNAP-IV) Scale and Strengths Difficulties Questionnaire.
Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and society. The diagnosis of ADHD is mainly based on clinical interview of parents and children with assistance of teachers' reports. Self-administered rating scales are useful for screening, assistance of diagnosis, and measurement of symptom changes over time or due to treatment effect. The goals of this study are to establish the norms and psychometric properties of the Chinese version of teacher and parent forms of the Swanson, Nolan, and Pelham, version IV (SNAP-IV) and the teacher, parent, and student forms of the Strengths and Difficulties Questionnaire (SDQ) for future studies on ADHD in Taiwanese populations.
Subjects and Methods: This is a cross-sectional, school-based survey with a multi-stage sampling method. The participants include a school-based sample of 3534 first to eighth graders was recruited from four areas: Taipei City, Taoyuan County, Tainan City and Chiayi County. Among them, 200students will be reassessed at 2-week interval for the test-retest reliability study. The instruments comprise the Chinese version of Child Behavioral Checklist (CBCL), SDQ, SNAP-IV, and Adult ADHD Rating Scale. The informants include student participants older than 10 years old, their parents, and teachers. The main statistical methods include Pearson correlation, intraclass correlation, Chronbach's α for internal consistency, and mixed model to address lack of independence within the same classes and schools.
Read more
Anticipated Goals: We expect that this study will reach the following objectives:
- to obtain the primitive information about the prevalence of ADHD symptoms and emotional/behavioral problems among children and adolescents in Taipei and Yun-Ling;
- to enhance the awareness of school teachers and counselors about ADHD and other behavioral/emotional problems among students;
- to establish psychometric properties of the Chinese versions of SNAP-IV and SDQ for future use in clinical, school, and research settings.
Read the detailed description
This protocol was prepared in Chinese
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- ADHD, SNAP-IV, SDQ, ASRS, reliability, validity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJan 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, Department of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491361
- Sponsor's protocol ID
- 9461700519
- Other IDs
- NTUH95-301
- Status last verified
- Aug 2008
- First submitted
- 23 Jun 2007
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Achenbach, T. M., and Ruffle, T. M. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies Pediatrics in Review (2000) 21(8):265-71. Becker, A., Woerner, W., Hasselhorn, M., et al. Validation of the parent and teacher SDQ in a clinical sample. European Child & Adolescent Psychiatry (2004) 13 Suppl 2:II11-6. Goodman, R., Ford, T., Corbin, T., et al. Using the Strengths and Difficulties Questionnaire (SDQ) multi-informant algorithm to screen looked-after children for psychiatric disorders. European Child & Adolescent Psychiatry (2004) 13 Suppl 2:II25-31. Yang, H. J., Soong, W. T., Chiang, C. N., et al. Competence and behavioral/emotional problems among Taiwanese adolescents as reported by parents and teachers. Journal of the American Academy of Child & Adolescent Psychiatry (2000) 39(2):232-9.
Gau SS, Lin CH, Hu FC, Shang CY, Swanson JM, Liu YC, Liu SK. Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, Version IV Scale-Teacher Form. J Pediatr Psychol. 2009 Sep;34(8):850-61. doi: 10.1093/jpepsy/jsn133. Epub 2008 Dec 12.
PubMed 19074488
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Study of the Chinese Versions of the Swanson, Nolan, and Pelham, Version IV (SNAP-IV) Scale and Strengths Difficulties Questionnaire.
- ClinicalTrials.gov ID
- NCT00491361
- Acronym / sponsor ID
- 9461700519
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- ADHD, SNAP-IV, SDQ, ASRS, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 26 Jun 2007 (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.
Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and society. The diagnosis of ADHD is mainly based on clinical interview of parents and children with assistance of teachers' reports. Self-administered rating scales are useful for screening, assistance of diagnosis, and measurement of symptom changes over time or due to treatment effect. The goals of this study are to establish the norms and psychometric properties of the Chinese version of teacher and parent forms of the Swanson, Nolan, and Pelham, version IV (SNAP-IV) and the teacher, parent, and student forms of the Strengths and Difficulties Questionnaire (SDQ) for future studies on ADHD in Taiwanese populations.
Subjects and Methods: This is a cross-sectional, school-based survey with a multi-stage sampling method. The participants include a school-based sample of 3534 first to eighth graders was recruited from four areas: Taipei City, Taoyuan County, Tainan City and Chiayi County. Among them, 200students will be reassessed at 2-week interval for the test-retest reliability study. The instruments comprise the Chinese version of Child Behavioral Checklist (CBCL), SDQ, SNAP-IV, and Adult ADHD Rating Scale. The informants include student participants older than 10 years old, their parents, and teachers. The main statistical methods include Pearson correlation, intraclass correlation, Chronbach's α for internal consistency, and mixed model to address lack of independence within the same classes and schools.
Anticipated Goals: We expect that this study will reach the following objectives:
- to obtain the primitive information about the prevalence of ADHD symptoms and emotional/behavioral problems among children and adolescents in Taipei and Yun-Ling;
- to enhance the awareness of school teachers and counselors about ADHD and other behavioral/emotional problems among students;
- to establish psychometric properties of the Chinese versions of SNAP-IV and SDQ for future use in clinical, school, and research settings.
Detailed description
This protocol was prepared in Chinese
Study design
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- School-based subjects \& Clinical subjects with ADHD
Key inclusion criteria (2 listed)
- School-based subjects: around 3600 grade 1 to grade 8 students aged 6-16 from four sites in Taiwan and their parents (n = 7200)
- Clinical subjects with ADHD: children and adolescents ages 6-16, who are diagnosed with ADHD, IQ >70, parents and teachers consent to completion of questionnaires.
Key exclusion criteria (1 listed)
- Clinical subjects with ADHD: those who are comorbid with pervasive developmental disorder and/or mental retardation or other severe psychiatric disorders. Oppositional defiant disorder and conduct disorder are not excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Nov 2012.
- BackgroundAchenbach, T. M., and Ruffle, T. M. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies Pediatrics in Review (2000) 21(8):265-71. Becker, A., Woerner, W., Hasselhorn, M., et al. Validation of the parent and teacher SDQ in a clinical sample. European Child & Adolescent Psychiatry (2004) 13 Suppl 2:II11-6. Goodman, R., Ford, T., Corbin, T., et al. Using the Strengths and Difficulties Questionnaire (SDQ) multi-informant algorithm to screen looked-after children for psychiatric disorders. European Child & Adolescent Psychiatry (2004) 13 Suppl 2:II25-31. Yang, H. J., Soong, W. T., Chiang, C. N., et al. Competence and behavioral/emotional problems among Taiwanese adolescents as reported by parents and teachers. Journal of the American Academy of Child & Adolescent Psychiatry (2000) 39(2):232-9.
- Derived from this study: PubMed 19074488Gau SS, Lin CH, Hu FC, Shang CY, Swanson JM, Liu YC, Liu SK. Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, Version IV Scale-Teacher Form. J Pediatr Psychol. 2009 Sep;34(8):850-61. doi: 10.1093/jpepsy/jsn133. Epub 2008 Dec 12.
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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.
Susan Shur-Fen Gau, MD, PhD principal investigator
Department of Psychiatry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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 14 Nov 2012. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00491361, which also lists 2 linked publications.
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 14 Nov 2012.