Attention Deficit Disorder With HyperactivityNCT05651685
Treatment Recommendations for Patients With ADHD TDApp2
An observational study of Attention Deficit Disorder With Hyperactivity, run by Universitat de Girona at 1 site in Spain.
Trial summary
The purpose of this study is to compare the recommendations made by TDApp2 with those by relevant clinical practice guidelines in children/adolescents with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2022to 28 Jun 2024
- 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 17 years
- All sexes
- Child
Study population: Children and adolescents with ADHD requiring treatment initiation for ADHD or requiring a treatment change will be enrolled for 6 weeks.
Who may be able to join
- Patients aged 6-17 yo
- Meeting DSM 5 criteria for ADHD
- Requiring treatment initiation for ADHD or requiring a treatment change
Who cannot join
- Patients who are receiving treatment for ADHD and who are well controlled with it
- Patients who do not have a suitable electronic device for TDApp2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assesment of TDApp2 an eHelath Tool to Make Pharmacologic and Non-pharmacologic Treatment Recommendations for Patients With ADHD
The purpose of this study is to compare the recommendations made by TDApp2 with those by relevant clinical practice guidelines in children/adolescents with ADHD.
Read the detailed description
Clinical practice guidelines (CPG) allow optimizing medical decisions and health care based on the best evidence available. Nevertheless, CPGs have several limitations. First, many GPC are outdated shortly after their publication. Second, CPG recommendations are often not applicable to many patients treated in clinical practice. Most CPGs do not make recommendations for complex patients with comorbidities. Another limitation is that patients involvement in CPGs development is still poor. To overcome these limitations, study investigators developed TDApp, an eHealth tool to formulate decentralized, participatory, individualized and automated pharmacologic treatment recommendations for patients with Attention Deficit Hyperactivity Disorder. TDApp was initially tested in a clinical sample of ADHD patients (https://clinicaltrials.gov/ct2/show/NCT04228094), but, as it was the first human use, treatment recommendations were kept hidden to the clinicians until the last patient enrolled completed study participation. This safeguard was implemented to avoid potential misguidance. After completing this study, the investigators developed a new iteration of TDApp (TDApp2) that can also recommend non-pharmacological interventions.
In this study, the investigators aim to assess TDApp2: an eHealth tool that formulates participatory, participatory, explainatory and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder. The recommendations made by TDApp2 will be compared with those made by relevant clinical practice guidelines in children/adolescents with ADHD.
A 6-week, one group, open label study will be conducted. Tirty-two children/adolescents aged < 18 yo with ADHD and their parents will use TDApp. The treatment recommendations made by the TDApp2 will be compared to those made by relevant CPG (American Academy of Pediatrics CPG, Canadian ADHD Resource Alliance (CADDRA) GPC, National Institute for Health and Care Excellence (NICE) GPC, the Australian ADHD Professionals Association guideline, and the Spanish GPC). As the study will be carried out in Catalonia (Spain), the primary comparison will be performed vs. the Spanish CPG. Also, TDApp2 recommendations will be compared with the actual treatment prescribed by the clinicians.
- Keywords
- eHealth, evidence based medicine, clinical decission support systems
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TDApp2 | This cohort will use TDApp2: an eHealth tool that formulates participatory, individualized, explainatory and automated treatment recommendations for patients with Attention Deficit Hyperactivity Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment recommended
Treatment recommended consists on the treatment recommended to the patient with ADHD by TDApp2 and CPG. The number and type of recommended treatments will be compared.
Measured: Week 1
Secondary outcomes (14)
Pharmacological distance according to the the NbN2R classification
The pharmacological distance corresponds to the number of pharmacological targets and modes of action that are different between two drugs according to the the NbN2R classification. E.g., the pharmacological distance between methylphenidate and atomoxetine is 16 because they are two different chemical entities and their pharmacological targets and modes of action are rather different (methylphenidates acts primarily on the dopamine (DA) neurotransmission and secondarily on the norepinephrine (NE) one, and inhibits the DA and NE transporters and releases DA and NE, while atomoxetine is a selective NE transporter inhibitor). Conversely, as methylphenidate and dexmethylphenidate act on the same pharmacological targets and have the same mode of action their pharmacological distance is 1 because they are 2 different chemical entities although closely related.
The pharmacological distance ranges 1-26 with higher score denoting a greater pharmacological distance
Measured: Week 1
ADHD symptom severity as assessed by the DSM 5 Attention-Deficit/Hyperactivity Disorder Rating Scale
ADHD symptom severity assessed with the DSM 5 Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS).
The DSM 5 ADHD-RS ranges 0-54 with higher score denoting a worse outcome.
Measured: Baseline and week 6
Global assessment of severity of illness as assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale
The CGI-S measures symptom severity of patients with mental disorders. CGI ranges 1-7 with higher score denoting a worse outcome.
Measured: Baseline and week 6
Sense of coherence as assessed by the Sense of Coherence (SOC)-13 by Antonovsky
The degree to which the patient views the world and the individual environment as comprehensible, manageable, and meaningful as assessed by the Sense of Coherence (SOC)-13 by Antonovsky.
Measured: Week 1 and week 3
Individuals' confidence in their capacity to act in the ways necessary to reach specific goals as assessed by the Bäbler, Schwarzar, and Jerusalem self-efficacy scale
The individuals' confidence in their capacity to act in the ways necessary to reach specific goals will be assessed with the Bäbler, Schwarzar, and Jerusalem self-efficacy scale.
Measured: Week 1 and week 3
Health literacy as assessed by the health literacy questionnaire 16-item, European Health Literacy Survey Questionnaire (HLS-EU-Q16)
The degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions and actions for themselves and others. It will be assessed with the health literacy questionnaire 16-item, European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Measured: Week 1 and week 3
Knowledge about ADHD as assessed by an ad hoc test
Knowledge about ADHD will be assessed by means of an ad hoc test containing 15 statements and the patient/parent will indicate whether they are true or false. The total score ranges 0-15 with higher score denoting a better outcome.
Measured: Week 1 and week 3
Treatment prescribed
This is a qualitative outcome corresponding to the pharmacological or non-pharmacological treatment prescribed by the clinician, therfore it has no units nor range.
Measured: Week 1
Patient satisfaction with the educational material as assessed by a 5-point Likert scale
Patients will be asked to rate their satisfaction with the educational material using a 5-point Likert scale. The total score ranges 1-5 with higher score denoting a better outcome.
Measured: Week 1
Patient satisfaction with the decision-making process as assessed by a 5-point Likert scale
Patients will be asked to rate their satisfaction with the decision-making process using a 5-point Likert scale. The total score ranges 1-5 with higher score denoting a better outcome.
Measured: Week 1
Perceived usefulness of the clinical recommendations as assessed by a 5-point Likert scale
Clinicians will be asked to rate the degree to which they preceive TDApp2 treatment recommendations useful using a 5-point Likert scale. The total score ranges 1-5 with higher score denoting a better outcome.
Measured: Week 1
Adverse events
Adverse events occured during the study
Measured: Weeks 3 and 6
Patient perceived satisfaction with the treatment as assessed by a 5-point Likert scale
Patient satisfaction with the treatment using a 5-point Likert scale. The total score ranges 1-5 with higher score denoting a better outcome.
Measured: Week 6
Clinicians satisfaction with the treatment recommendations formulated by TDApp2 as assessed by a 5-point Likert scale
Clinician satisfaction (Clinicians fulfilment of their expectations or needs derived from the treatment recommendations formulated by TDApp2) with the treatment using a 5-point Likert scale.The total score ranges 1-5 with higher score denoting a better outcome.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start12 Dec 2022
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Girona
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Assistència Sanitària
- Responsible party
- Principal investigator, Xavier Castells, Universitat de Girona
- Investigators
- Xavier Castells, Principal investigator, Universitat de Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651685
- Sponsor's protocol ID
- TDApp2
- Status last verified
- Jun 2024
- First submitted
- 20 Nov 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of TDApp2 an eHelath Tool to Make Pharmacologic and Non-pharmacologic Treatment Recommendations for Patients With ADHD
- ClinicalTrials.gov ID
- NCT05651685
- Acronym / sponsor ID
- TDApp2
- Keywords
- eHealth, evidence based medicine, clinical decission support systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitat de GironaUniversity, hospital or other
- Collaborators
- Institut d'Assistència Sanitària
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 15 Dec 2022 (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 purpose of this study is to compare the recommendations made by TDApp2 with those by relevant clinical practice guidelines in children/adolescents with ADHD.
Detailed description
Clinical practice guidelines (CPG) allow optimizing medical decisions and health care based on the best evidence available. Nevertheless, CPGs have several limitations. First, many GPC are outdated shortly after their publication. Second, CPG recommendations are often not applicable to many patients treated in clinical practice. Most CPGs do not make recommendations for complex patients with comorbidities. Another limitation is that patients involvement in CPGs development is still poor. To overcome these limitations, study investigators developed TDApp, an eHealth tool to formulate decentralized, participatory, individualized and automated pharmacologic treatment recommendations for patients with Attention Deficit Hyperactivity Disorder. TDApp was initially tested in a clinical sample of ADHD patients (https://clinicaltrials.gov/ct2/show/NCT04228094), but, as it was the first human use, treatment recommendations were kept hidden to the clinicians until the last patient enrolled completed study participation. This safeguard was implemented to avoid potential misguidance. After completing this study, the investigators developed a new iteration of TDApp (TDApp2) that can also recommend non-pharmacological interventions.
In this study, the investigators aim to assess TDApp2: an eHealth tool that formulates participatory, participatory, explainatory and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder. The recommendations made by TDApp2 will be compared with those made by relevant clinical practice guidelines in children/adolescents with ADHD.
A 6-week, one group, open label study will be conducted. Tirty-two children/adolescents aged < 18 yo with ADHD and their parents will use TDApp. The treatment recommendations made by the TDApp2 will be compared to those made by relevant CPG (American Academy of Pediatrics CPG, Canadian ADHD Resource Alliance (CADDRA) GPC, National Institute for Health and Care Excellence (NICE) GPC, the Australian ADHD Professionals Association guideline, and the Spanish GPC). As the study will be carried out in Catalonia (Spain), the primary comparison will be performed vs. the Spanish CPG. Also, TDApp2 recommendations will be compared with the actual treatment prescribed by the clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDApp2 | – | –This cohort will use TDApp2: an eHealth tool that formulates participatory, individualized, explainatory and automated treatment recommendations for patients with Attention Deficit Hyperactivity Disorder |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children and adolescents with ADHD requiring treatment initiation for ADHD or requiring a treatment change will be enrolled for 6 weeks.
Key inclusion criteria (3 listed)
- Patients aged 6-17 yo
- Meeting DSM 5 criteria for ADHD
- Requiring treatment initiation for ADHD or requiring a treatment change
Key exclusion criteria (2 listed)
- Patients who are receiving treatment for ADHD and who are well controlled with it
- Patients who do not have a suitable electronic device for TDApp2
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
Treatment recommended
Time frame: Week 1
Treatment recommended consists on the treatment recommended to the patient with ADHD by TDApp2 and CPG. The number and type of recommended treatments will be compared.
14 secondary outcomes
Pharmacological distance according to the the NbN2R classification
Time frame: Week 1
ADHD symptom severity as assessed by the DSM 5 Attention-Deficit/Hyperactivity Disorder Rating Scale
Time frame: Baseline and week 6
Global assessment of severity of illness as assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale
Time frame: Baseline and week 6
Sense of coherence as assessed by the Sense of Coherence (SOC)-13 by Antonovsky
Time frame: Week 1 and week 3
Individuals' confidence in their capacity to act in the ways necessary to reach specific goals as assessed by the Bäbler, Schwarzar, and Jerusalem self-efficacy scale
Time frame: Week 1 and week 3
Health literacy as assessed by the health literacy questionnaire 16-item, European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time frame: Week 1 and week 3
Knowledge about ADHD as assessed by an ad hoc test
Time frame: Week 1 and week 3
Treatment prescribed
Time frame: Week 1
Patient satisfaction with the educational material as assessed by a 5-point Likert scale
Time frame: Week 1
Patient satisfaction with the decision-making process as assessed by a 5-point Likert scale
Time frame: Week 1
Perceived usefulness of the clinical recommendations as assessed by a 5-point Likert scale
Time frame: Week 1
Adverse events
Time frame: Weeks 3 and 6
Patient perceived satisfaction with the treatment as assessed by a 5-point Likert scale
Time frame: Week 6
Clinicians satisfaction with the treatment recommendations formulated by TDApp2 as assessed by a 5-point Likert scale
Time frame: Week 6
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 1 Jul 2024.
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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.
Xavier Castells principal investigator
Universitat de Girona
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 Disorder With Hyperactivity, run by Universitat de Girona at 1 site in Spain.
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 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 1 Jul 2024. 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 Spain. 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?
Treatment recommended (time frame: Week 1). 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 1 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.