Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05142384 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jun 1, 2026 → Mar 31, 2027
See other at-risk trials from Oregon Research Institute

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jun 1, 2026 to Mar 31, 2027
    • Interventions: Mom-Net (Behavioral), Treatment as Usual/Waitlist (Combination Product) to Mom-Net (Behavioral), Treatment as Usual/Waitlist (Behavioral)
    v9
  2. Minor 2 versions Re-verified since Feb 4, 2025, no change to tracked fieldsv7-v8
  3. Minor Study completion date: Jun 1, 2026 to Mar 31, 2027v6
  4. Minor Enrollment target: 1200 to 960
    • Site contact updated
    v5
  5. Notable Primary and study completion dates: Oct 2025 to Jun 1, 2026v4 Show 4 more changesShow less
    • Start date: Oct 28, 2022 to Dec 1, 2022
    • Secondary endpoints: 4 to 10
    • Site details revised
    • Eligibility criteria expanded, about 3 words
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2022 to Oct 28, 2022
    • Site details revised
    v3
  2. Minor Start date: Sep 2022 to Oct 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Low income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. The intervention program also includes live coaching to help the mothers engage and learn the CBT material. Mom-Net has been shown to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment, in earlier controlled trials. In this project the investigators are examining whether access to Mom-Net can be expanded by delivering it in Head Starts (HS). To address that broad question, the investigators will focus on two sets of scientific questions: 1. Implementation Questions: e.g., Can HS agencies deliver the program successfully; do HSs choose to sustain the program after the research project ends; what agency characteristics are associated with successful delivery of Mom-Net); 2. Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching? Head Start agencies will be randomized to deliver either Mom-Net with the usual high-intensity coaching or with a low-intensity coaching alternative. Within each agency, depressed mothers will be randomized to receive either: 1) Mom-Net program; or 2) Treatment as Usual (TAU;) referral to community mental health providers). Mothers initially assigned to the TAU condition, will have the option of receiving Mom-Net at a later date. Mothers will participate in assessments of depressive symptoms, parenting behavior, and child adjustment at Time 1 (T1; prior to randomization); and Time 2 (T2; after the intervention period) and Time 3 (T3; one year after T1).
Trial Details
NCT Number NCT05142384
Lead Sponsor Oregon Research Institute
Conditions
(from sponsor)
Depression
Related terms Depression
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov