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Personlig opmærksomhedsunderskud/hyperaktivitetsforstyrrelse (ADHD) medicineksperimentundersøgelse

15. april 2026 opdateret af: Children's Hospital Medical Center, Cincinnati

Open-label afprøvning af personlige medicineksperimenter for at informere beslutninger om fremtidig opmærksomhedsunderskud/hyperaktivitetsforstyrrelse (ADHD) medicinbrug

Det primære mål med projektet er at teste personaliserede medicineksperimenter for at informere beslutninger om fremtidig medicinbrug. Vores centrale hypotese er, at vores intervention inden for subjektet vil føre til øget unges involvering i beslutningstagning og fald i usikkerhed om fremtidig medicinbrug. Efterforskerne betragter dette åbne studie som et pilotstudie for at teste gennemførligheden, acceptabiliteten og den foreløbige effektivitet af medicineksperimentinterventionen og berettiger derfor yderligere test i et fremtidigt større forsøg.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Efterforskerne vil udføre et pilot-, enkeltarms-, åbent-label forsøg med medicineksperimentinterventionen blandt 30 unge og forældre, der oplever usikkerhed om fortsat medicinbrug. Da medicinforsøgsinterventionen ikke er klinisk relevant for unge, der tager en ikke-stimulerende ADHD-medicin, vil de blive udelukket. På tilmeldingstidspunktet vil familier gennemføre baseline-foranstaltninger elektronisk og planlægge et personligt besøg. Efterforskerne vil verificere den ordinerede medicin og antallet af dage dækket med medicin i det seneste år ved hjælp af dispenseringsdata. Under besøget vil forældre og unge vælge et af fem medicinforsøg, som de skal gennemføre sammen og spore virkningerne i det ønskede tidsrum.

  1. Foretag ingen ændringer. Spor nuværende tilstand: Fortsæt med at tage medicin, som den er ordineret i øjeblikket.
  2. Tag medicin på ikke-skoledage. Spor virkninger: Hvis du ikke i øjeblikket tager medicin på ikke-skoledage, skal du begynde at tage medicin på disse dage og spore virkningerne.
  3. Stop med at tage medicin på ikke-skoledage. Spor effekter. Hvis du i øjeblikket tager medicin på ikke-skoledage, skal du stoppe med at tage medicin på disse dage og spore virkningerne.
  4. Lav en formel prøveudtagning af medicin. Tag den nuværende medicin som foreskrevet i 2 uger, mens du sporer, og stop derefter med at tage medicin i 2-4 uger, mens du fortsætter med at spore.
  5. Skift dosis eller skift medicin. Overvej en anden medicin eller anden dosis af aktuel medicin i samråd med undersøgelseslægen. Spor effekterne.

Når dyader har gennemført medicineksperimentet, vil de gennemføre et opfølgende studiebesøg for at gennemgå resultaterne fra eksperimentet, diskutere gennemførligheden af ​​softwaren og gennemføre afslutningsforanstaltninger.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Cincinnati Children's Hospital Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier: Deltagere til undersøgelsen skal opfylde alle følgende kriterier:

  1. Samtykke: En forælder eller værge skal give skriftligt informeret samtykke
  2. Samtykke: Unge skal give skriftligt samtykke for at deltage i undersøgelsen
  3. 11-15 år
  4. Behandlet for ADHD af børnelæge
  5. Første gang ordineret ADHD medicin mere end et år før indskrivning
  6. Fyldt mindst én recept på stimulerende medicin inden for det seneste år
  7. Usikkerhed om fortsat ADHD-medicinbrug
  8. Kun ét barn pr. husstand kan deltage i undersøgelsen. For familier, der har mere end ét barn, der er potentielt berettiget, kan de beslutte, hvilket af deres børn, der passer bedst til undersøgelsen.

Eksklusionskriterier: Eksklusionskriterier: Deltagerne vil blive udelukket fra undersøgelsen, hvis de opfylder et af følgende kriterier:

  1. Har ikke pålidelig adgang til internettet i deres hjem eller et andet sted.
  2. Vil ikke tillade deres barn at få adgang til internettet til studierelaterede aktiviteter.
  3. Er ikke i stand til eller villige til at sende eller modtage tekstbeskeder.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Alle vil vælge en af ​​fem medicineksperimentmuligheder at gennemføre.
Andet: Personligt ADHD-medicineksperiment
Alle forældre/ungdomsdyader vil vælge og gennemføre et medicineksperiment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decision Making Involvement Scale [Parent Seek] - Reported by Child
Tidsramme: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decision Making Involvement Scale [Parent Seek] - Parent Report
Tidsramme: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decision Making Involvement Scale [Child Express] - Child Report
Tidsramme: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decision Making Involvement Scale [Child Express] - Parent Report
Tidsramme: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
Decisional Conflict - Parent Report
Tidsramme: The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected. Options presented will be: continue [medication regimen from experiment], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other [write in]. The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale. The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.
The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
Decisional Conflict - Child Report
Tidsramme: The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected. Options presented will be: continue [medication regimen from experiment], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other [write in]. The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale. The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.
The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
Decision Making Involvement Scale - Joint/Options
Tidsramme: The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 2 (post), which is 4-12 weeks after study visit 1.
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 2 (post), which is 4-12 weeks after study visit 1.
Decision Making Involvement Scale - Child Express
Tidsramme: The investigators will reference the Decision-Making Involvement Scale and Control Preferences Scale collected at Study Visit 2, which is 4-12 weeks after study visit 1.
A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.
The investigators will reference the Decision-Making Involvement Scale and Control Preferences Scale collected at Study Visit 2, which is 4-12 weeks after study visit 1.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in Intention to Give/Take Medication on School Days
Tidsramme: Collected at study visit 1 and 4-12 weeks later at study visit 2.
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on school days. This was assessed using a scale question from the Unified Theory of Behavior Change. Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding school days.
Collected at study visit 1 and 4-12 weeks later at study visit 2.
Difference in Intention to Give/Take Medication on Weekend Days
Tidsramme: Collected at study visit 1 and 4-12 weeks later at study visit 2.
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on weekend days. This was assessed using a scale question from the Unified Theory of Behavior Change. Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding weekend days.
Collected at study visit 1 and 4-12 weeks later at study visit 2.
Difference in Intention to Give/Take Medication on School Vacation Days
Tidsramme: Collected at study visit 1 and 4-12 weeks later at study visit 2.
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on school vacation days. This was assessed using a scale question from the Unified Theory of Behavior Change. Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding school vacation days.
Collected at study visit 1 and 4-12 weeks later at study visit 2.
System Usability Scale Total Score
Tidsramme: Collected at study visit 2 (which is 4-12 weeks after study visit 1).
Parents and children completed the System Usability Scale (SUS) to assess the usability of the mehealth platform for completing a personalized medication experiment. The SUS is a 10-item questionnaire with items rated on a 5-point agreement scale. Item scores are converted and summed using standard scoring procedures to produce a total score ranging from 0 to 100, with higher scores indicating better usability/better outcome.
Collected at study visit 2 (which is 4-12 weeks after study visit 1).
Implementation of Decision
Tidsramme: 3 months after study visit 2 (which is 4-12 weeks after study visit 1).
We obtained pharmacy dispensing records to confirm eligibility and to assess decision implementation within 90 days post-study, identifying cases where pharmacy records contradicted the dyad's decision about their future ADHD treatment.
3 months after study visit 2 (which is 4-12 weeks after study visit 1).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital Medical Center, Cincinnati

Efterforskere

  • Ledende efterforsker: William Brinkman, MD, MEd, MSc, Cincinnati Children's

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. november 2023

Primær færdiggørelse (Faktiske)

1. maj 2025

Studieafslutning (Faktiske)

1. november 2025

Datoer for studieregistrering

Først indsendt

13. februar 2024

Først indsendt, der opfyldte QC-kriterier

7. marts 2024

Først opslået (Faktiske)

12. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. april 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023-0528

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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