ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start
NCT05142384 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 960
Last updated 2026-03-23
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).
Conditions
Interventions
- BEHAVIORAL
-
Mom-Net
Mom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff. In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later.
- COMBINATION_PRODUCT
-
Treatment as Usual/Waitlist
HS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies
Sponsors & Collaborators
-
Oregon Research Institute
lead OTHER
Principal Investigators
-
Edward G Feil, Ph.D. · Oregon Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-01
- Primary Completion
- 2026-06-01
- Completion
- 2027-03-31
Countries
- United States
Study Locations
More Related Trials
-
Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
NCT05134103 ·Status: WITHDRAWN ·Phase: NA
-
Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy
NCT03957330 ·Status: COMPLETED ·Phase: NA
-
Treatment of Depression in Mothers in Home Visitation
NCT01221701 ·Status: COMPLETED ·Phase: NA
-
Family Cognitive Behavioral Therapy for Preventing Depression in Children
NCT00183482 ·Status: COMPLETED ·Phase: NA
-
Individual MBCT vs. CBT in Major Depression: A Pilot Study.
NCT05108701 ·Status: COMPLETED ·Phase: NA
-
Parent Psychoeducation and Cognitive Behavior Therapy for Latino Adolescents With Depression
NCT00118469 ·Status: UNKNOWN ·Phase: PHASE2
-
Psilocybin-assisted CBT for Depression
NCT05227612 ·Status: COMPLETED ·Phase: PHASE1
-
Online MBCT vs HEP for Depressive Symptoms in Older Adults: RCT
NCT06189118 ·Status: COMPLETED ·Phase: NA
-
Virtual Mindfulness Training for Adults With History of Depression
NCT05347719 ·Status: COMPLETED ·Phase: NA
-
ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content
NCT04260750 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of a Technology Assisted Behavioral Intervention in Assisting People With Major Depressive Disorder
NCT00719979 ·Status: COMPLETED ·Phase: PHASE1
-
New Technologies for Cognitive Behavior Therapy (CBT) Treatment of Adolescent Depression
NCT01868867 ·Status: COMPLETED ·Phase: NA
-
Brief CBT for the Treatment of Depression During Inpatient Hospitalization
NCT03011619 ·Status: WITHDRAWN ·Phase: NA
-
Therapist-guided Internet-delivered Cognitive Behavioural Therapy
NCT03304392 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents with Depression
NCT04977856 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
ICBT for Antenatal Depression
NCT02366429 ·Status: COMPLETED ·Phase: NA
-
Stepped Telemental Health Care Intervention for Depression
NCT01906476 ·Status: COMPLETED ·Phase: NA
-
Pilot Study Assessing Computerized Cognitive Behavioral Therapy for Depression
NCT01990053 ·Status: COMPLETED ·Phase: NA
-
Preventing Perinatal Depression
NCT06525922 ·Status: COMPLETED ·Phase: NA
-
Internet Intervention for the Prevention of Depression - Approaches to Improving Mood
NCT01080105 ·Status: WITHDRAWN ·Phase: PHASE1
-
Feasibility of Internet-delivered CBT for Adolescents With Depression
NCT04117789 ·Status: COMPLETED ·Phase: NA
-
Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments
NCT02911441 ·Status: UNKNOWN ·Phase: NA
-
Using SMART Experimental Design to Personalize Treatment for Child Depression
NCT01880814 ·Status: COMPLETED ·Phase: NA
-
The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse
NCT01145872 ·Status: COMPLETED ·Phase: PHASE3
-
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
NCT01591720 ·Status: COMPLETED ·Phase: NA