ADHDNCT04636216
Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
A study testing COPE parent training in people with ADHD, run by Florida International University at 1 site in United States.
Trial summary
Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the… Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- COPE parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 30 May 2021
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis
- Intelligence Quotient (IQ) greater than or equal to 70
- At least 1 parent/guardian who can attend zoom sessions
- Access to reliable internet connection for zoom meetings
Who cannot join
- Evidence of psychosis, suicidal behaviors, or autism level 2/3
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Children and Families
Amherst, New York, 14226
About this study
Official title: Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings
Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.
Read the detailed description
This study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. They will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. Process measures will include data collection related to attendance and engagement in the activities. Risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. Benefits include the parent receiving an effective intervention.
- Conditions
- ADHD
- Being tested
- COPE parent training
- 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.
COPE parent trainingBehavioural
Weekly 1.5 hour parent training meetings for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Community Parent Education Program (COPE) parent training program | Experimental | Parents will enroll in an 8-week, group parenting program. Receives: Behavioral: COPE parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observations of parenting behaviors during parent-child interaction
Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands
Measured: 8 weeks
Impairment Rating Scale
Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start3 Nov 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Model description
- Open, single-group trial
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Greg Fabiano, Florida International University
- Investigators
- Gregory A Fabiano, Ph.D., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636216
- Sponsor's protocol ID
- IRB-20-0484
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2020
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings
- ClinicalTrials.gov ID
- NCT04636216
- Acronym / sponsor ID
- IRB-20-0484
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- 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.
Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.
Detailed description
This study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. They will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. Process measures will include data collection related to attendance and engagement in the activities. Risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. Benefits include the parent receiving an effective intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open, single-group trial
| Arm | Type | Receives |
|---|---|---|
| Community Parent Education Program (COPE) parent training program | Experimental | Behavioral: COPE parent trainingParents will enroll in an 8-week, group parenting program. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ADHD diagnosis
- Intelligence Quotient (IQ) greater than or equal to 70
- At least 1 parent/guardian who can attend zoom sessions
- Access to reliable internet connection for zoom meetings
Key exclusion criteria (1 listed)
- Evidence of psychosis, suicidal behaviors, or autism level 2/3
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 |
|---|---|---|
| COPE parent trainingWeekly 1.5 hour parent training meetings for eight weeks | Behavioural | Community Parent Education Program (COPE) parent training program |
Primary outcome
Observations of parenting behaviors during parent-child interaction
Time frame: 8 weeks
Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands
Impairment Rating Scale
Time frame: 8 weeks
Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)
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 28 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Gregory A Fabiano, Ph.D. principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPE parent training in people with ADHD, run by Florida International University 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 4 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 28 Oct 2021. 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?
Observations of parenting behaviors during parent-child interaction (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 28 Oct 2021.