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Trives personcentreret planlægningsprogram for unge voksne med føtal alkoholspektrumforstyrrelser

25. april 2026 opdateret af: Christie Petrenko, University of Rochester

Randomiseret kontrolleret forsøg med det trives personcentrerede planlægningsprogram for unge voksne med FASD

Denne undersøgelse tester et nyt program kaldet Thrive. THRIVE -programmet blev udviklet for unge voksne med føtal alkoholspektrumforstyrrelser (FASD). Thrive bruger en personcentreret planlægningsmetode, hvilket betyder, at den fokuserer på, hvad der er vigtigst for den unge voksen med FASD. Den unge voksne inviterer mennesker, der støtter dem til at hjælpe dem med at planlægge at nå deres mål. I denne undersøgelse vil vi medtage 60 unge voksne med FASD. Halvdelen af ​​de unge voksne vil straks prøve Thrive -programmet. Den anden halvdel vil være på en venteliste og kommer til at starte programmet ca. 8 måneder senere. Alle afslutter online -undersøgelser tre gange under undersøgelsen. De foretager undersøgelser i begyndelsen af ​​undersøgelsen, efter 4 måneder og efter 8 måneder. Vi vil gerne vide, om Thrive -programmet hjælper unge voksne med at nå deres mål og få støtte, når de har brug for det.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne type 1 hybrid effektivitetsimplementeringsforsøg foreslår et 2-arm parallelt pilot-RCT-design. I alt 60 unge voksne med FASD tildeles tilfældigt i (1) Thrive Intervention eller (2) Waitlist -sammenligningsgruppen ved hjælp af et 50:50 allokeringsforhold. Da dette er et hybridforsøg af type 1, understreger måling effektivitetsresultater med indsamling af nogle implementeringsresultater/proces for at informere om planlægning af efterfølgende større skalaforsøg. I overensstemmelse med piloten RCT -design vil analyse fokusere på at bestemme gennemførligheden af ​​intervention, forsøgsprocedurer og måling og interventionsproces. Disse oplysninger optimerer succes med den planlagte R01-rct.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inkluderingskriterier:

  • Ung voksen mellem 18 og 25 år
  • Bor i USA
  • Har en diagnose af føtal alkoholspektrumforstyrrelse eller bekræftet prenatal alkoholeksponering

Ekskluderingskriterier:

  • Har ikke adgang til internettet eller dataplanen, der tillader videokonferencer
  • Er ikke i stand til at lytte eller tale på engelsk

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Øjeblikkelig Start Individuelt Format
Deltagerne modtager psykoedukation umiddelbart efterfulgt af individuelle målændrings-, planlægnings- og implementeringssessioner.
Adfærdsmæssigt: Thrive Program
Thrive er en personcentreret planlægningsintervention, der leveres i faser, herunder identificering, psykoedukation, målfastsættelse og implementering. Programmet leveres via Zoom over cirka 12 til 15 sessioner. Deltagere kan modtage interventionen umiddelbart eller efter en forsinkelse og gennemføre målfastsættelse enten i en individuel format eller en gruppeformat, der involverer deres sociale netværk.
Eksperimentel: Format for Gruppe med Umiddelbar Start
Deltagerne modtager psykoedukation umiddelbart efterfulgt af gruppebaserede målsætningssessioner, der involverer deres sociale støttenetværk.
Adfærdsmæssigt: Thrive Program
Thrive er en personcentreret planlægningsintervention, der leveres i faser, herunder identificering, psykoedukation, målfastsættelse og implementering. Programmet leveres via Zoom over cirka 12 til 15 sessioner. Deltagere kan modtage interventionen umiddelbart eller efter en forsinkelse og gennemføre målfastsættelse enten i en individuel format eller en gruppeformat, der involverer deres sociale netværk.
Eksperimentel: Forsinket Start Individuelt Format
Deltagerne gennemfører en venteperiode, før de modtager psykoedukation efterfulgt af individuelle målsætnings-, planlægnings- og implementeringssessioner.
Adfærdsmæssigt: Thrive Program
Thrive er en personcentreret planlægningsintervention, der leveres i faser, herunder identificering, psykoedukation, målfastsættelse og implementering. Programmet leveres via Zoom over cirka 12 til 15 sessioner. Deltagere kan modtage interventionen umiddelbart eller efter en forsinkelse og gennemføre målfastsættelse enten i en individuel format eller en gruppeformat, der involverer deres sociale netværk.
Eksperimentel: Forsinket Start Gruppe Format
Deltagerne gennemfører en venteperiode, før de modtager psykoedukation efterfulgt af gruppebaserede målsætningssessioner, der involverer deres sociale støttenetværk.
Adfærdsmæssigt: Thrive Program
Thrive er en personcentreret planlægningsintervention, der leveres i faser, herunder identificering, psykoedukation, målfastsættelse og implementering. Programmet leveres via Zoom over cirka 12 til 15 sessioner. Deltagere kan modtage interventionen umiddelbart eller efter en forsinkelse og gennemføre målfastsættelse enten i en individuel format eller en gruppeformat, der involverer deres sociale netværk.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Goal Setting Capacity Scale Total Score
Tidsramme: Baseline through approximately 10 months
The Goal Setting Capacity Scale is an 8 item scale that measures an individual's agency and capacity to set clear goals. Items are rated on a 5 point Likert scale from 1 Completely Disagree to 5 Completely Agree. Item scores are summed to produce a total score (range 8-40), with higher scores indicating greater goal setting capacity. The outcome measure is the change in total score from baseline to follow up for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Patient Measure of Collaborative Goal Setting Total Score
Tidsramme: Baseline through approximately 10 months
The Patient Measure of Collaborative Goal Setting is a 37 item scale measuring the extent to which participants report collaborative goal setting across domains including listening and learning from each other, sharing ideas, caring relationship, agreement on a measurable objective, and support for goal achievement. Items are rated on a Likert scale from 1 "completely disagree" to 5 "completely agree." Items are aggregated to produce a total score (range 37 to 185), with higher scores indicating greater perceived collaborative goal setting. The outcome measure is the change in total score from baseline to follow up for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Autonomy Subscale Score
Tidsramme: Baseline through approximately 10 months
The Basic Psychological Need Satisfaction and Frustration Scale is a 24 item scale assessing psychological need satisfaction and frustration in the domains of autonomy, competence, and relatedness. Items are rated on a 5 point Likert scale from 1 Not at all true to 5 Completely true. The autonomy subscale has 8 items with a range of 8 to 40. Higher scores indicate greater autonomy need satisfaction. This outcome measure is the change from baseline in the autonomy subscale score for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Competence Subscale Score
Tidsramme: Baseline through approximately 10 months
The Basic Psychological Need Satisfaction and Frustration Scale is a 24 item scale assessing psychological need satisfaction and frustration in the domains of autonomy, competence, and relatedness. Items are rated on a 5 point Likert scale from 1 Not at all true to 5 Completely true. The competence subscale has 8 items with scores ranging from 8 to 40. Higher scores indicate greater competence need satisfaction. This outcome measure is the change from baseline in the competence subscale score for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Basic Psychological Need Satisfaction and Frustration Scale Relatedness Subscale Score
Tidsramme: Baseline through approximately 10 months
The Basic Psychological Need Satisfaction and Frustration Scale is a 24 item scale assessing psychological need satisfaction and frustration in the domains of autonomy, competence, and relatedness. Items are rated on a 5 point Likert scale from 1 Not at all true to 5 Completely true. The relatedness subscale has 8 items with scores ranging from 8 to 40. Higher scores indicate greater relatedness need satisfaction. This outcome measure is the change from baseline in the relatedness subscale score for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Personal Well being Index Total Score
Tidsramme: Baseline through approximately 10 months
The Personal Well being Index Intellectual Disability Version is an 8 item measure of subjective well being and quality of life. Items assess material, physical, mental, and general well being using a 5 point pictorial scale. Item scores are summed to generate a total score (range 8 to 40), with higher scores indicating better perceived well being. The outcome measure is the change in total score from baseline to follow up for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Youth Participation in Planning Scale Participation/Voice Subscale Score
Tidsramme: Baseline through approximately 10 months
The Youth Participation in Planning Scale is a 16 item measure assessing participants' perceptions of meaningful participation in planning. Items are rated on a 5 point Likert scale from 1 Never or almost never to 5 Always or almost always. Several items were adapted to reference the participant's support network and involvement in goal setting. The Participation/Voice subscale has 8 items with scores ranging from 8 to 40. Higher scores indicate greater perceived participation in planning. This outcome measure is the change from baseline in Participation/Voice subscale score for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Youth Participation in Planning Scale Preparation to Participate Subscale Score
Tidsramme: Baseline through approximately 10 months
The Youth Participation in Planning Scale is a 16 item measure assessing participants' perceptions of meaningful participation in planning. Items are rated on a 5 point Likert scale from 1 Never or almost never to 5 Always or almost always. Several items were adapted to reference the participant's support network and involvement in goal setting. The Preparation to Participate subscale has 4 items with scores ranging from 4 to 20. Higher scores indicate greater perceived participation in planning. This outcome measure is the change from baseline in Preparation to Participate subscale score for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Change from Baseline in Youth Participation in Planning Scale Accountability Subscale Score
Tidsramme: Baseline through approximately 10 months
The Youth Participation in Planning Scale is a 16 item measure assessing participants' perceptions of meaningful participation in planning. Items are rated on a 5 point Likert scale from 1 Never or almost never to 5 Always or almost always. Several items were adapted to reference the participant's support network and involvement in goal setting. The Accountability scale consists of 4 items with scores ranging from 4 to 20. Higher scores indicate greater perceived participation in planning. This outcome measure is the change from baseline in Accountability subscale score for each participant, calculated as follow up score minus baseline score.
Baseline through approximately 10 months
Goal Attainment Scaling Rating at Follow up
Tidsramme: Follow up assessments after goal setting through approximately 10 months
Participants establish formal goals as part of the Thrive intervention. Personalized Goal Attainment Scaling is used to assess attainment of these goals on a 5 point scale with benchmarks for less than expected to more than expected goal attainment. The rating is entered at follow up visits after goal setting. Scores range from 1 to 5. Higher ratings indicate greater goal attainment.
Follow up assessments after goal setting through approximately 10 months
Change from Baseline in Theoretical Framework of Acceptability Total Score
Tidsramme: Post intervention assessments through approximately 10 months
Theoretical Framework of Acceptability is an 8 item measure assessing intervention acceptability. Each item is rated on a scale from 1 to 5, with scaling anchors varying by item. Item scores are aggregated to produce a total score (range 8 to 40), with higher scores indicating greater acceptability of the intervention. The outcome measure is the change from baseline to follow up for each participant, calculated as follow up score minus baseline score.
Post intervention assessments through approximately 10 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Rochester

Samarbejdspartnere

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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)

14. april 2026

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

31. august 2028

Datoer for studieregistrering

Først indsendt

2. juni 2025

Først indsendt, der opfyldte QC-kriterier

2. juni 2025

Først opslået (Faktiske)

11. juni 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00010579
  • 1R61AA030780 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

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 .

Kliniske forsøg med Thrive Program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner