Evaluating the Efficacy of Central Executive Training (CET) For Young Children With ADHD
20. august 2026 opdateret af: Michael J. Kofler, Florida State University
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET) [R61 Phase], followed by a randomized controlled trial of CET+BPT for young children with ADHD [R33 Phase].
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Children's Learning Clinic
- Telefonnummer: 850-645-7423
- E-mail: clc@psy.fsu.edu
Studiesteder
-
-
Florida
-
Tallahassee, Florida, Forenede Stater, 32306
- Rekruttering
- Children's Learning Clinic at Florida State University
-
Kontakt:
- Children's Learning Clinic
- Telefonnummer: 850-645-7423
- E-mail: clc@psy.fsu.edu
-
Ledende efterforsker:
- Michael Kofler, PhD
-
-
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
Inclusion Criteria:
- principal ADHD diagnoses (via K-SADS); (b) parent BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range (>90th percentile) based on age and sex; (c) teacher BASC-3 ADHD Problems or ADHD-RS ADHD-Combined scale in clinical/borderline range based on age and sex
Exclusion Criteria:
- (a) gross neurological, sensory, or motor impairment; (b) history of seizure disorder, psychosis, bipolar, or severe dysregulation disorders that may interfere with study participation (e.g., disruptive mood dysregulation, conduct, intermittent explosive, reactive attachment); (c) intellectual disability or WPPSI/WISC short-form FSIQ<70; (d) conditions requiring acute intervention, e.g., active suicidality; and (e) non-English speaking child or parent.
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: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Central executive training
|
Computerized, adaptive central executive working memory training protocol
|
|
Aktiv komparator: Behavioral parent training
|
Behavioral parent training
|
|
Andet: Central executive training + concurrent behavioral parent training
|
Computerized, adaptive central executive working memory training protocol
Behavioral parent training
|
|
Ingen indgriben: Treatment as usual/waitlist
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
ADHD Rating Scale (ADHD-RS)
Tidsramme: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary outcomes (T-scores)
Tidsramme: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Informant reports of social skills, emotion regulation, parent-child relationships, and impairments
|
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
|
Feasibility/acceptability
Tidsramme: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Client satisfaction, system usability, expectancies
|
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Working memory test battery
Tidsramme: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
|
Actigraphy (Proportional Integrating Measure)
Tidsramme: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
|
Academic performance rating scale
Tidsramme: Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Change from baseline to immediate post-treatment and maintenance of gains up to 3 months after treatment completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Kofler, PhD, Florida State University
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)
1. maj 2024
Primær færdiggørelse (Anslået)
1. december 2030
Studieafslutning (Anslået)
1. december 2030
Datoer for studieregistrering
Først indsendt
5. august 2026
Først indsendt, der opfyldte QC-kriterier
20. august 2026
Først opslået (Faktiske)
25. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4R33MH127031
- 5R61MH127031 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymized individual participant data that underlie results in a publication will be shared upon reasonable request, subject to approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).
IPD-delingstidsramme
During peer review of study manuscript or after publication, after obtaining approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).
IPD-delingsadgangskriterier
Approval by the study's Data and Safety Monitoring Board (DSMB) and execution of a Data Use Agreement (DUA).
IPD-deling Understøttende informationstype
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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