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TIDES 2NCT07048574

TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 3 months later.

See at-risk trials from State University of New York at Buffalo

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Dec 1, 2026 Show 5 more changesShow less
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description revised
    • Site details revised at 5 of 13 sites
    • Publications: 1 to 2
    • Eligibility criteria expanded, about 5 words
  2. Primary endpoint revised
    • Primary completion date: Jun 2026 to Aug 31, 2026
    • Secondary endpoints: 1 to 6
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis
Timeframe: 07/01/2024 - 06/30/2028

Secondary (6)

Diagnostic performance of brief behavioral and mental health screening instruments
Longitudinal changes in child mental health symptoms
Cystic fibrosis-specific health-related quality of life
Parent symptoms of depression and anxiety
Neuropsychiatric symptoms associated with CFTR modulator therapy
Show 1 moreShow less
Qualitative experiences related to CFTR modulator-associated neuropsychiatric symptoms

Arms and interventions

Preschool / Early Childhood Group (18 mos - 5 years)

300 children with CF and their parents will be recruited. This cohort will help identify early signs of internalizing and externalizing behaviors, attention-related concerns, and the impact of CF treatments on psychosocial health. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy.

School-Age Group (6 - 11 years)

300 children with CF and their parents will be recruited. Includes school-aged children who can self-report their emotional and behavioral health, beginning at age 8 years. This group will be assessed for emerging mental health symptoms, cognitive development, and procedural anxiety related to CF treatments. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy.

Sites

13 sites in 1 country