Treatment Recommendations for Patients With ADHD TDApp2

NCT05651685 | Completed

• 1 other identifier: TDApp2
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

eHealth; evidence based medicine; clinical decission support systems

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 1

Secondary Outcomes (14)

• Pharmacological distance according to the the NbN2R classification

  Week 1

• ADHD symptom severity as assessed by the DSM 5 Attention-Deficit/Hyperactivity Disorder Rating Scale

  Baseline and week 6

• Global assessment of severity of illness as assessed by the Clinical Global Impression - Severity of Illness (CGI-S) Scale

  Baseline and week 6

• Sense of coherence as assessed by the Sense of Coherence (SOC)-13 by Antonovsky

  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

  Week 1 and week 3

Study Arms (1)

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

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with ADHD requiring treatment initiation for ADHD or requiring a treatment change will be enrolled for 6 weeks.

You may qualify if:

• Patients aged 6-17 yo
• Meeting DSM 5 criteria for ADHD
• Requiring treatment initiation for ADHD or requiring a treatment change

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Girona: lead
• Institut d'Assistència Sanitària: collaborator

Study Sites (1)

Institut d'Assitència Sanitària

Salt, Catalonia, Spain

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xavier Castells

  Universitat de Girona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 15, 2022
• Study Start: December 12, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

ES (1)