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Medikamenteksperimentstudie med personlig oppmerksomhetssvikt/hyperaktivitetsforstyrrelse (ADHD).

15. april 2026 oppdatert av: Children's Hospital Medical Center, Cincinnati

Åpen utprøving av personlig tilpassede medisineksperimenter for å informere avgjørelser om fremtidig oppmerksomhetsunderskudd/hyperaktivitetsforstyrrelse (ADHD) medisinbruk

Hovedmålet med prosjektet er å teste ut persontilpassede medisineksperimenter for å informere beslutninger om fremtidig medisinbruk. Vår sentrale hypotese er at vår intervensjon vil føre til økt involvering av ungdom i beslutningstaking innen faget og redusert usikkerhet om fremtidig medisinbruk. Etterforskerne ser på denne åpne studien som en pilotstudie for å teste gjennomførbarheten, akseptabiliteten og den foreløpige effekten av medisineksperimentintervensjonen og garanterer derfor ytterligere testing i en fremtidig større studie.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Etterforskerne vil gjennomføre en pilot, enarms, åpen utprøving av medisineksperimentintervensjonen blant 30 ungdommer og foreldre som opplever usikkerhet om fortsatt medisinbruk. Fordi medikamenteksperimentintervensjonen ikke er klinisk relevant for ungdom som tar en ikke-stimulerende ADHD-medisin, vil de bli ekskludert. På påmeldingstidspunktet vil familier fullføre grunnlinjetiltak elektronisk og planlegge et personlig besøk. Etterforskerne vil verifisere medisinen som er foreskrevet og antall dager dekket med medisin det siste året ved hjelp av dispenseringsdata. Under besøket vil foreldre og ungdom velge ett av fem medisineksperimenter som de skal fullføre sammen og spore effektene i ønsket tidsperiode.

  1. Gjør ingen endringer. Spor nåværende tilstand: fortsett å ta medisiner slik det er foreskrevet.
  2. Ta medisiner på skolefrie dager. Spor effekter: Hvis du for øyeblikket ikke tar medisiner på ikke-skoledager, begynn å ta medisiner på disse dagene og følg effekten.
  3. Slutt å ta medisiner på ikke-skoledager. Spor effekter. Hvis du for øyeblikket tar medisiner på ikke-skoledager, slutte å ta medisiner på disse dagene og følg effekten.
  4. Gjør en formell utprøving av medisiner. Ta gjeldende medisiner som foreskrevet i 2 uker mens du sporer, og slutt deretter å ta medisiner i 2-4 uker mens du fortsetter å spore.
  5. Endre dose eller bytt medisin. Vurder en annen medisin eller annen dose av gjeldende medisin i samråd med studielegen. Spor effektene.

Når dyader har fullført medikamenteksperimentet, vil de gjennomføre et oppfølgingsstudiebesøk for å gjennomgå resultatene fra eksperimentet, diskutere gjennomførbarheten av programvaren og fullføre studiesluttstiltak.

Studietype

Intervensjonell

Registrering (Faktiske)

31

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45220
        • Cincinnati Children's Hospital Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier: Deltakere for studien må oppfylle alle følgende kriterier:

  1. Samtykke: En forelder eller verge må gi skriftlig informert samtykke
  2. Samtykke: Ungdom må gi skriftlig samtykke for å delta i studien
  3. 11-15 år
  4. Behandlet for ADHD av barnelege
  5. Første gang foreskrevet ADHD-medisin mer enn ett år før påmelding
  6. Fyllte ut minst én resept på sentralstimulerende medisin det siste året
  7. Usikkerhet om fortsatt ADHD-medisinbruk
  8. Kun ett barn per husstand kan delta i studien. For familier som har mer enn ett barn som potensielt er kvalifisert, kan de bestemme hvilke av barna deres som passer best for studien.

Eksklusjonskriterier: Eksklusjonskriterier: Deltakere vil bli ekskludert fra studien hvis de oppfyller noen av følgende kriterier:

  1. Ikke ha pålitelig tilgang til internett hjemme eller et annet sted.
  2. Vil ikke tillate at barnet deres får tilgang til internett for studierelaterte aktiviteter.
  3. Er ikke i stand til eller villig til å sende eller motta tekstmeldinger.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Innblanding
Alle vil velge ett av fem medisineksperimentalternativer å fullføre.
Annen: Personlig tilpasset ADHD-medisineksperiment
Alle foreldre/ungdomsdyader vil velge og fullføre et medisineksperiment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Hospital Medical Center, Cincinnati

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. november 2023

Primær fullføring (Faktiske)

1. mai 2025

Studiet fullført (Faktiske)

1. november 2025

Datoer for studieregistrering

Først innsendt

13. februar 2024

Først innsendt som oppfylte QC-kriteriene

7. mars 2024

Først lagt ut (Faktiske)

12. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. april 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2023-0528

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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