Online cognitive behavioral therapy for depressed mothers in Head Start programs
ICBT for Maternal Depression: Community Implementation in Head Start
This study is testing an online therapy program for depressed mothers in Head Start programs to see if more or less coaching helps them feel better and stick with the program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 960 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Oregon Research Institute Academic / other |
| Locations | 1 site (Springfield, Oregon) |
| Trial ID | NCT05142384 on ClinicalTrials.gov |
What this trial studies
This project aims to implement Mom-Net, an internet-based cognitive behavioral therapy (CBT) program, to support low-income mothers experiencing depression. The program includes live coaching to enhance engagement and learning of CBT techniques. The study will compare two implementation strategies: one with high-intensity coaching and another with low-intensity coaching, to evaluate their effectiveness and sustainability within Head Start agencies. The research will follow a structured process to assess both the effectiveness of the intervention and the implementation outcomes.
Who should consider this trial
Good fit: Ideal candidates are low-income mothers of children aged 2-5 years who are enrolled in a participating Head Start program and exhibit elevated symptoms of depression.
Not a fit: Patients with major mental illnesses or cognitive disabilities that interfere with participation, or those at high risk of suicide, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce depressive symptoms in mothers, leading to improved parenting and child development outcomes.
How similar studies have performed: Previous studies have shown that similar internet-based CBT interventions can be effective, suggesting potential for success in this implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Mothers * Elevated symptoms of depression (i.e., Patient Health Questionnaire or Edinburgh Postnatal Depression Scale score at or above 10) * Have a child 2-5 years enrolled in a participating Head Start; be able to communicate in English or Spanish. Inclusion Criteria: Child \- 2-5 years of age and enrolled in participation Head Start Exclusion Criteria: Mothers * Evidence of psychosis or other major mental illness or cognitive disability (observed during recruitment or by HS report) that would interfere with meaningful participation * Endorsed score of 3 on final item of the PHQ9 or EPDS indicating frequent thoughts of suicide. Could be enrolled at later date if elevated risk ameliorates Exclusion Criteria: Children * No exclusion criteria
Where this trial is running
Springfield, Oregon
- Oregon Research Institute — Springfield, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Edward G Feil, Ph.D. — Oregon Research Institute
- Study coordinator: Edward G Feil, Ph.D.
- Email: Edf@ori.org
- Phone: 541-484-2123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.