Attention Deficit Hyperactivity DisorderNCT01161719
Effectiveness Study of Videoconferencing on Teaching Parent Training Skills to Parents of Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing parent training in people with Attention Deficit Hyperactivity Disorder, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of group parent training taught through videoconferencing on ADHD treatment via a comparison between participants using traditional face-to-face parent training sessions and a group using teleconferencing. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2009
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV criteria for any subtype of ADHD.
- ADHD must be the primary diagnosis if there is comorbidity.
Who cannot join
- Subjects with significant medical conditions, which are not stable on current outpatient treatment regimen.
- Subjects with severe psychiatric disorders (i.e., bipolar disorder, autism, schizophrenia, major depression).
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis MIND Institute
Sacramento, California, 95817
About this study
Official title: The Effectiveness of Videoconferencing on Teaching Parent Training Skills to Parents of Children With ADHD
The purpose of this study is to evaluate the effectiveness of group parent training taught through videoconferencing on ADHD treatment via a comparison between participants using traditional face-to-face parent training sessions and a group using teleconferencing.
Read the detailed description
Subjects with a primary diagnosis of ADHD between the ages of 6 and 14 years were enrolled. All subjects were screened and assessed for psychiatric and learning disorders using structured interviews (DICA, parent and child version, Reich et al, 2000) based on DSM IV criteria and parent and teacher rating scales. Mothers took the Beck Depression Inventory (BDI) to assess for depression.
Parents or primary caregivers were randomized to two treatment arms (videoconference or face to face). Ten sessions of weekly parent training through either videoconference or face-to-face delivery was conducted using Dr. Russell A. Barkley's manual. A non-mandatory skill training and play group was offered to the children of both groups while parents attended the parent training group in order to provide child care for the parents during the training sessions.
Following outcomes will be measured to assess the effectiveness of the intervention:
Primary outcome Acceptance of the parent and children on the mode the communication as well as parent training.
Secondary outcomes:
- Parent-child relations measured by the Parent Child Relationship Questionnaire (PCQ)
- The Vanderbilt Assessment Scale (parent \& teacher versions), Children Global Assessment Scale (CGAS), Clinical Global Impression- Severity score (CGI-S), and Clinical Global Impression-Improvement Scores (CGI-I) assessed the severity of core symptoms of ADHD and oppositional/aggressive symptoms.
- The parent and teacher-rated versions of the Social Skills Rating System (SSRS) assessed social skills.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- parent training
- Keywords
- ADHD, Parent training, Videoconference
- 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.
parent trainingBehavioural
Behavioral management skill training
| Study group | Role | What they receive |
|---|---|---|
| Videoconference | Experimental | Parent training through videoconference Receives: Behavioral: parent training |
| Control | Active comparator | Parent training through face to face conference Receives: Behavioral: parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of the parent and children on the mode the communication as well as parent training
Acceptance of the parent and children on the mode the communication as well as parent training will be measured by a Likert scale, which is a 12 intem questionaire to assess parent's satisfaction with the intervention.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionJun 2009
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.
- More trials run by University of California, DavisThe 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuhuan Xie, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161719
- Sponsor's protocol ID
- 200816003
- Status last verified
- Jan 2016
- First submitted
- 25 Jun 2010
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xie Y, Dixon JF, Yee OM, Zhang J, Chen YA, Deangelo S, Yellowlees P, Hendren R, Schweitzer JB. A study on the effectiveness of videoconferencing on teaching parent training skills to parents of children with ADHD. Telemed J E Health. 2013 Mar;19(3):192-9. doi: 10.1089/tmj.2012.0108. Epub 2013 Feb 13.
PubMed 23405952
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Videoconferencing on Teaching Parent Training Skills to Parents of Children With ADHD
- ClinicalTrials.gov ID
- NCT01161719
- Acronym / sponsor ID
- 200816003
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Parent training, Videoconference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Jul 2010 (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 evaluate the effectiveness of group parent training taught through videoconferencing on ADHD treatment via a comparison between participants using traditional face-to-face parent training sessions and a group using teleconferencing.
Detailed description
Subjects with a primary diagnosis of ADHD between the ages of 6 and 14 years were enrolled. All subjects were screened and assessed for psychiatric and learning disorders using structured interviews (DICA, parent and child version, Reich et al, 2000) based on DSM IV criteria and parent and teacher rating scales. Mothers took the Beck Depression Inventory (BDI) to assess for depression.
Parents or primary caregivers were randomized to two treatment arms (videoconference or face to face). Ten sessions of weekly parent training through either videoconference or face-to-face delivery was conducted using Dr. Russell A. Barkley's manual. A non-mandatory skill training and play group was offered to the children of both groups while parents attended the parent training group in order to provide child care for the parents during the training sessions.
Following outcomes will be measured to assess the effectiveness of the intervention:
Primary outcome Acceptance of the parent and children on the mode the communication as well as parent training.
Secondary outcomes:
- Parent-child relations measured by the Parent Child Relationship Questionnaire (PCQ)
- The Vanderbilt Assessment Scale (parent \& teacher versions), Children Global Assessment Scale (CGAS), Clinical Global Impression- Severity score (CGI-S), and Clinical Global Impression-Improvement Scores (CGI-I) assessed the severity of core symptoms of ADHD and oppositional/aggressive symptoms.
- The parent and teacher-rated versions of the Social Skills Rating System (SSRS) assessed social skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoconference | Experimental | Behavioral: parent trainingParent training through videoconference |
| Control | Active comparator | Behavioral: parent trainingParent training through face to face conference |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- DSM-IV criteria for any subtype of ADHD.
- ADHD must be the primary diagnosis if there is comorbidity.
Key exclusion criteria (2 listed)
- Subjects with significant medical conditions, which are not stable on current outpatient treatment regimen.
- Subjects with severe psychiatric disorders (i.e., bipolar disorder, autism, schizophrenia, major depression).
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 |
|---|---|---|
| parent trainingBehavioral management skill training | Behavioural | Control, Videoconference |
Primary outcome
Acceptance of the parent and children on the mode the communication as well as parent training
Time frame: One year
Acceptance of the parent and children on the mode the communication as well as parent training will be measured by a Likert scale, which is a 12 intem questionaire to assess parent's satisfaction with the intervention.
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 26 Jan 2016.
- Derived from this study: PubMed 23405952Xie Y, Dixon JF, Yee OM, Zhang J, Chen YA, Deangelo S, Yellowlees P, Hendren R, Schweitzer JB. A study on the effectiveness of videoconferencing on teaching parent training skills to parents of children with ADHD. Telemed J E Health. 2013 Mar;19(3):192-9. doi: 10.1089/tmj.2012.0108. Epub 2013 Feb 13.
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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.
Yuhuan Xie, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent training in people with Attention Deficit Hyperactivity Disorder, run by University of California, Davis 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 2 inclusion and 2 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 26 Jan 2016. 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.
What does the primary outcome measure?
Acceptance of the parent and children on the mode the communication as well as parent training (time frame: One year). 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 NCT01161719, 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 26 Jan 2016.