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Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of ADHD

A legfontosabb adatok

Ki végzi
University of California, Davis
Hol
Sacramento (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Fut, nem toboroz
Résztvevők
8 fő, tervezett
Kezdés
2023. aug. 1.
Befejezés
2026. okt. 31.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Early Self-Regulation Intervention
A regiszteradat frissítve
2025. december 15.

Ki vehet részt

Életkor
12 hónap – 18 hónap
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki nem vehet részt

  • Known genetic disorders (e.g., fragile X syndrome, Tuberous Sclerosis),
  • History of traumatic brain injury,
  • Severe visual, hearing, or motor impairment or fragile health condition that would prevent the child from validly participating in the assessment procedures, and
  • Birth before 33 weeks' gestation,
  • A caregiver may be excluded from participation if the caregiver is already engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior)

Egyéb feltételek

  • Inclusion Critera:
  • Infants must be enrolled in UC Davis IRB protocol #1077801 and
  • Be between the ages of 12-18 months at the time of intake assessment,
  • Have a first-degree relative with ADHD (parent or sibling),
  • Exhibit early symptoms of ADHD based on examiner observation as indicated by at least 1 subscale on the Behavior Rating Inventory for Children (BRIC) rated 4 or higher,
  • Expression of at least 1 concern about the child's behavior/development by the caregiver; Caregivers must:
  • Be identified as the infants' primary caregivers,
  • Be English-speaking,
  • Have access to wired or wireless network technology to access the internet in their homes

Helyszínek itt: Egyesült Államok

  • UC Davis MIND InstituteSacramento, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.

A vizsgálat csoportja

  • Telehealth InterventionA vizsgált kezelés

    A multiple baseline design across subjects will be used with varying introduction of treatment elements. Baseline periods will be 3, 5, and 7 sessions with the baseline period of 3 and 5 sessions repeated twice for subsequent participants. An intense intervention phase will follow the baseline phase in which 45-60 minute treatment sessions will occur twice per week over the course of 4-6 weeks for a total of 8 sessions. Each week during the intense intervention phase, caregiver coaches will introduce a new treatment technique to the caregiver and allow for caregiver practice with immediate feedback. At the conclusion of the intense intervention phase, coaches will provide "booster" sessions with the caregivers once weekly for 1 month (4 sessions total).

    Kezelés: Early Self-Regulation Intervention

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
A regiszteradat frissítve
2025. december 15.