Attention Deficit Disorder With HyperactivityNCT00071656
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
A study testing Psychosocial (behavioral) Intervention in people with Attention Deficit Disorder With Hyperactivity, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to develop and implement a treatment that focuses on behaviors to reduce symptom severity and functional impairment in patients with Attention Deficit Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Psychosocial (behavioral) Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2007
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD, Predominantly Inattentive Type
- Public or private school attendance
- English speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
HALP Clinic, Children's Center at Langley Porter, UCSF
San Francisco, California, 94143
About this study
Official title: Psychosocial Treatment for ADHD Inattentive Type I
The purpose of this study is to develop and implement a treatment that focuses on behaviors to reduce symptom severity and functional impairment in patients with Attention Deficit Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this study is to apply the treatment to larger-scale trials to determine its effectiveness and generalizability.
Read the detailed description
ADHD-I is a highly prevalent and serious childhood disorder that affects academic and social development. The symptoms of ADHD-I differ from those of the well-studied ADHD Combined Type. Unfortunately, studies of psychosocial interventions for ADHD-I are currently unavailable. Effective treatments for ADHD-I are still needed.
Participants are randomly assigned to receive either a behavioral intervention or treatment as usual for 10 to 12 weeks. The behavioral intervention includes parent and child skill development groups, family meetings, and consultation with the child's teacher to address attention problems and areas of impairment at home and school. Parent and child interviews, teacher and child ratings, and psychoeducational testing are used to assess participants. Participants are assessed post-treatment and at a 2-month follow-up visit.
- Being tested
- Psychosocial (behavioral) Intervention
- 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.
Psychosocial (behavioral) InterventionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2003 (estimated)
- Study startSep 2002
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071656
- Sponsor's protocol ID
- R21MH065927
- Other IDs
- R21MH065927, DSIR CT-S
- Status last verified
- Aug 2013
- First submitted
- 29 Oct 2003
- Last updated
- 9 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Treatment for ADHD Inattentive Type I
- ClinicalTrials.gov ID
- NCT00071656
- Acronym / sponsor ID
- R21MH065927
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Study completion
- Jun 2007 (actual)
- First posted
- 30 Oct 2003 (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 develop and implement a treatment that focuses on behaviors to reduce symptom severity and functional impairment in patients with Attention Deficit Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this study is to apply the treatment to larger-scale trials to determine its effectiveness and generalizability.
Detailed description
ADHD-I is a highly prevalent and serious childhood disorder that affects academic and social development. The symptoms of ADHD-I differ from those of the well-studied ADHD Combined Type. Unfortunately, studies of psychosocial interventions for ADHD-I are currently unavailable. Effective treatments for ADHD-I are still needed.
Participants are randomly assigned to receive either a behavioral intervention or treatment as usual for 10 to 12 weeks. The behavioral intervention includes parent and child skill development groups, family meetings, and consultation with the child's teacher to address attention problems and areas of impairment at home and school. Parent and child interviews, teacher and child ratings, and psychoeducational testing are used to assess participants. Participants are assessed post-treatment and at a 2-month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ADHD, Predominantly Inattentive Type
- Public or private school attendance
- English speaking
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Psychosocial (behavioral) Intervention | Behavioural | – |
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 9 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial (behavioral) Intervention in people with Attention Deficit Disorder With Hyperactivity, run by University of California, San Francisco at 1 site in United States.
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 3 inclusion and 0 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 9 Aug 2013. 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 United States. 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?
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 9 Aug 2013.