Treatment as Usual/Waitlist / Mom-Net / Depression · Interventional Study

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

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned two-level randomized trial examining delivery of Mom-Net (internet-based cognitive behavioral therapy with coaching) for maternal depression through Head Start agencies. No results are available; the registry record describes the study protocol and primary outcome measures (PHQ-9 depression symptoms, acceptability, implementation reach, and maternal engagement) to be assessed at baseline, 5 months, and 12 months.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Depression; age from 2 Years. Intervention: Mom-Net. Compared with: Treatment as Usual/Waitlist — Active Comparator. n = 960. 1 site: United States.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported.

Who this may help

If completed and positive, this trial could expand access to evidence-based depression treatment for economically disadvantaged mothers by embedding internet-based CBT with coaching in community Head Start programs. Results are not yet available; clinicians should monitor for publication.

Plain-language summary

This is a clinical trial registry record describing a planned interventional study with no results posted; it documents design and implementation intentions only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Patient Health Questionnaire-9 (PHQ-9) (assessed at Assessing change between baseline, post-intervention (5 months), and follow up…); Maternal Acceptability (Modified System Usability Scale) (assessed at Post intervention ( 5 months)); Screening Reach (Reach) (assessed at End of screening in year 2 of implementation); Implementation Reach (IReach) (assessed at End of Implementation in Year 2); Maternal Engagement (Engage) (assessed at Change between base-line and 5-month assessments)

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationDepression; age from 2 Years

Sample size960

InterventionMom-Net

ComparatorTreatment as Usual/Waitlist — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size960

Primary outcome measure 1Patient Health Questionnaire-9 (PHQ-9); change between baseline, post-intervention (5 months), and follow-up (12 months)

Primary outcome measure 2Maternal Acceptability (Modified System Usability Scale), post-intervention (5 months)

Primary outcome measure 3Screening Reach (Reach), end of screening in year 2 of implementation

Primary outcome measure 4Implementation Reach (IReach), end of implementation in year 2

Primary outcome measure 5Maternal Engagement (Engage), change between baseline and 5-month assessments

Clinical bottom line

Caveats

This is a registry record only; no efficacy or safety results are reported.
Recruitment is ongoing (status: recruiting); trial completion and result publication dates are not specified.
The registry does not report effect sizes, comparisons to prior controlled trials of Mom-Net, or specifics of coaching intensity protocols.
Generalizability to mothers outside Head Start settings or outside the enrollment region is not yet known.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Two-level randomization (agencies, then mothers); comparison to treatment as usual; prospective assessments at three timepoints.

Directness

strong

Primary outcome is PHQ-9 depression symptom change, a direct measure of clinical benefit in the target population.

Consistency

insufficient

No results reported; consistency cannot be assessed against other trials or evidence.

Risk of bias

insufficient

Registry record does not describe allocation concealment, blinding, or other bias mitigation; conduct not yet reported.

Sample adequacy

strong

Planned enrollment of 960 participants; large and adequate for detection of clinically meaningful depression reduction.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05142384). This is a study registration, not published results. Lead sponsor: Oregon Research Institute. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 960 participants (ESTIMATED). Conditions: Depression. Interventions: BEHAVIORAL: Mom-Net; BEHAVIORAL: Treatment as Usual/Waitlist. Primary outcome measures: Patient Health Questionnaire-9 (PHQ-9) , Assessing change between baseline, post-intervention (5 months), and follow up (12 months); Maternal Acceptability (Modified System Usability Scale) , Post intervention ( 5 months); Screening Reach (Reach) , End of screening in year 2 of implementation; Implementation Reach (IReach) , End of Implementation in Year 2; Maternal Engagement (Engage) , Change between base-line and 5-month assessments. Brief summary: 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Treatment as Usual/WaitlistMom-NetNCT05142384DepressionOregon Research Institute