ADHDNCT04402528
Preschool ADHD On-line Behavioral Treatment
A study testing Behavioral tools integrated within mehealth for ADHD software in people with ADHD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The primary goal of the proposed project is to test the feasibility of parent and teacher/childcare providers use of the ADHD web portal-integrated behavioral treatment modules with preschool children with ADHD in order to improve the access to and the integrity of evidence-based behavioral treatment strategies for… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- ADHD
- What is being tested?
- Behavioral tools integrated within mehealth for ADHD software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child has been diagnosed with ADHD, or shows significant signs and symptoms of ADHD.
- If child is being prescribed ADHD medication, child must currently be on a stable dosage of medication for 1 month.
- Child meets criteria for a research diagnosis of ADHD* based on the ADHD Rating Scale IV Preschool-Version and Impairment Rating Scale assessments that the parent completes.
- Children will be given a research diagnosis of ADHD if the following criteria are met: 1) parents endorse that children have 6 or more symptoms in either the inattentive or hyperactive-impulsive domains present "often" or "very often" on the ADHD Rating Scale IV-Preschool Version (ADHD-RS-IV-P) or Vanderbilt ADHD Rating Scale; or have inattentive symptom scores and/or hyperactive symptom scores >93th percentile for sex on the ADHD-RS-IV-P AND 2) child is experiencing ADHD-related impairment as shown by the parent or a teacher/childcare provider/additional adult scoring one or more items on the Impairment Rating Scale as a 3 or higher. Note: child behavior ratings from a teacher/childcare provider/additional adult on the ADHD-RS-IV-P and Impairment Rating Scale will not be required for study inclusion and children will not be excluded from the study on the basis of these ratings. Parents of children with a research diagnosis of ADHD will be eligible for study participation.
Who cannot join
- Parent does not have access to a computer or smartphone.
- Child has global developmental delay.
- Child has been diagnosed with autism spectrum disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Improving Rates of Behavioral Treatment in Preschoolers Through Mehealth for ADHD Software
The primary goal of the proposed project is to test the feasibility of parent and teacher/childcare providers use of the ADHD web portal-integrated behavioral treatment modules with preschool children with ADHD in order to improve the access to and the integrity of evidence-based behavioral treatment strategies for young children with ADHD.
Read the detailed description
Although behavioral interventions are the recommended first-line treatment for preschool children with Attention Deficit Hyperactivity Disorder (ADHD), the majority of preschool children receiving treatment for ADHD are treated with medication only. Barriers to preschool children receiving behavioral treatments include financial limitations, family logistical challenges, and the paucity of trained providers. Web-based approaches may be one innovative way to address these obstacles. Thus, the goal of the proposed study is to pilot-test an on-line behavioral intervention that has been integrated into the evidence-based mehealth for ADHD software (mehealth.com) to determine feasibility, acceptability, and preliminary efficacy. The investigators will enroll a community-based sample of caregivers and teachers/childcare providers of 20 preschool children with ADHD recruited from two DBPNet sites (Cincinnati and Boston) who will utilize the on-line behavioral tools to create and implement child behavior plans. The investigators will track system usage over a 9-month period to determine feasibility for mehealth's integrated behavioral tools intervention. Standardized measures and open-ended questions will be used to determine the intervention's acceptability to parents and teachers/childcare providers. In addition, parent and teacher/childcare providers ratings of child ADHD symptoms and impairment collected at baseline and at the 3-month, 6-month, and 9-month time points will be examined to provide preliminary estimates of efficacy. Ultimately, development of the mehealth for ADHD.com integrated behavioral tools may provide a cost-effective and convenient means of implementing behavioral plans for young children, thereby increasing access to behavioral treatments for preschoolers with ADHD. This scalable and disseminatable approach has great potential for use not only in clinical settings, but also in national Developmental-Behavioral Pediatrics Research Network multi-site research studies which require standardized behavioral intervention packages for preschool ADHD.
- Conditions
- ADHD
- Being tested
- Behavioral tools integrated within mehealth for ADHD software
- 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.
Behavioral tools integrated within mehealth for ADHD softwareBehavioural
Also called mehealth for ADHD
Integrated functionality within the mehealth for ADHD software allows parents and teachers/childcare providers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.
| Study group | Role | What they receive |
|---|---|---|
| mehealth portal with integrated behavioral tools | Experimental | Patients in this arm will use the mehealth for ADHD web-based software and have access to a module that allows parents and teachers/childcare providers to develop and implement behavioral interventions such as daily report cards online. Receives: Behavioral: Behavioral tools integrated within mehealth for ADHD software |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of days using mehealth behavior tracking system
Feasibility will be assessed by tracking system usage, including % of days when parents/teachers/childcare providers entered behavioral tracking data (to determine if data was entered for >85% of days) and % of days when earned rewards were administered (to determine if administration occurred for >85% of days).
Measured: 9 months
Acceptability with on-line behavioral treatment assessed by the System Usability Scale
System Usability Scale contains ten items rated on a Likert scale.
- SUS contains ten items rated on a Likert scale.
Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire (IAQ).
- The IAQ contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program.
Measured: 9 months
Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire
The Intervention Acceptability Questionnaire contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program
Measured: 9 months
Secondary outcomes (2)
ADHD Rating Scale-IV-Preschool Version
Descriptive statistics from parent-rated ADHD Rating Scale-IV-Preschool Version total symptom scores will be reported across time points. Please note that the word "ADHD" is not used as an abbreviation in "ADHD Rating Scale - IV - Preschool Version," that is the official name of the scale.
Measured: 9 months
Impairment Rating Scale
Descriptive statistics from parent-rated Impairment Rating Scale total symptom scores will be reported across time points
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start27 Mar 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.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Developmental Behavioral Pediatrics Research Network, HRSA/Maternal and Child Health Bureau, Boston Children's Hospital
- Responsible party
- Principal investigator, Tanya Froehlich, MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- Tanya Froehlich, MD, MS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402528
- Sponsor's protocol ID
- 2019-1274
- Status last verified
- Jul 2021
- First submitted
- 24 Apr 2020
- Last updated
- 15 Jul 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Rates of Behavioral Treatment in Preschoolers Through Mehealth for ADHD Software
- ClinicalTrials.gov ID
- NCT04402528
- Acronym / sponsor ID
- 2019-1274
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Developmental Behavioral Pediatrics Research Network, HRSA/Maternal and Child Health Bureau, Boston Children's Hospital
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 27 May 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.
The primary goal of the proposed project is to test the feasibility of parent and teacher/childcare providers use of the ADHD web portal-integrated behavioral treatment modules with preschool children with ADHD in order to improve the access to and the integrity of evidence-based behavioral treatment strategies for young children with ADHD.
Detailed description
Although behavioral interventions are the recommended first-line treatment for preschool children with Attention Deficit Hyperactivity Disorder (ADHD), the majority of preschool children receiving treatment for ADHD are treated with medication only. Barriers to preschool children receiving behavioral treatments include financial limitations, family logistical challenges, and the paucity of trained providers. Web-based approaches may be one innovative way to address these obstacles. Thus, the goal of the proposed study is to pilot-test an on-line behavioral intervention that has been integrated into the evidence-based mehealth for ADHD software (mehealth.com) to determine feasibility, acceptability, and preliminary efficacy. The investigators will enroll a community-based sample of caregivers and teachers/childcare providers of 20 preschool children with ADHD recruited from two DBPNet sites (Cincinnati and Boston) who will utilize the on-line behavioral tools to create and implement child behavior plans. The investigators will track system usage over a 9-month period to determine feasibility for mehealth's integrated behavioral tools intervention. Standardized measures and open-ended questions will be used to determine the intervention's acceptability to parents and teachers/childcare providers. In addition, parent and teacher/childcare providers ratings of child ADHD symptoms and impairment collected at baseline and at the 3-month, 6-month, and 9-month time points will be examined to provide preliminary estimates of efficacy. Ultimately, development of the mehealth for ADHD.com integrated behavioral tools may provide a cost-effective and convenient means of implementing behavioral plans for young children, thereby increasing access to behavioral treatments for preschoolers with ADHD. This scalable and disseminatable approach has great potential for use not only in clinical settings, but also in national Developmental-Behavioral Pediatrics Research Network multi-site research studies which require standardized behavioral intervention packages for preschool ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mehealth portal with integrated behavioral tools | Experimental | Behavioral: Behavioral tools integrated within mehealth for ADHD softwarePatients in this arm will use the mehealth for ADHD web-based software and have access to a module that allows parents and teachers/childcare providers to develop and implement behavioral interventions such as daily report cards online. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child has been diagnosed with ADHD, or shows significant signs and symptoms of ADHD.
- If child is being prescribed ADHD medication, child must currently be on a stable dosage of medication for 1 month.
- Child meets criteria for a research diagnosis of ADHD* based on the ADHD Rating Scale IV Preschool-Version and Impairment Rating Scale assessments that the parent completes.
Key exclusion criteria (3 listed)
- Parent does not have access to a computer or smartphone.
- Child has global developmental delay.
- Child has been diagnosed with autism spectrum disorder.
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 |
|---|---|---|
| Behavioral tools integrated within mehealth for ADHD softwareAlso: mehealth for ADHDIntegrated functionality within the mehealth for ADHD software allows parents and teachers/childcare providers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly. | Behavioural | mehealth portal with integrated behavioral tools |
Primary outcome
% of days using mehealth behavior tracking system
Time frame: 9 months
Feasibility will be assessed by tracking system usage, including % of days when parents/teachers/childcare providers entered behavioral tracking data (to determine if data was entered for >85% of days) and % of days when earned rewards were administered (to determine if administration occurred for >85% of days).
Acceptability with on-line behavioral treatment assessed by the System Usability Scale
Time frame: 9 months
System Usability Scale contains ten items rated on a Likert scale. - SUS contains ten items rated on a Likert scale. Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire (IAQ). - The IAQ contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program.
Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire
Time frame: 9 months
The Intervention Acceptability Questionnaire contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program
2 secondary outcomes
ADHD Rating Scale-IV-Preschool Version
Time frame: 9 months
Impairment Rating Scale
Time frame: 9 months
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 15 Jul 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.
Tanya Froehlich, MD, MS principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral tools integrated within mehealth for ADHD software in people with ADHD, run by Children's Hospital Medical Center, Cincinnati 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 3 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 15 Jul 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?
% of days using mehealth behavior tracking system (time frame: 9 months). The study lists 3 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 15 Jul 2021.