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

NCT05142384 | Recruiting DMC

• 1 other identifier: MH120237
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

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. 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. 2.Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching?

Conditions

Depression

Outcome Measures

Primary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  Well-established measure of maternal depression with 9 self-report items, each rated on a 0 (not at all) to 3 (nearly every day) scale; total score will be used; interpretation: scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe,and severe depression, respectively. Total score will be used to examine change from baseline to subsequent assessments.

  Assessing change between baseline, post-intervention (5 months), and follow up (12 months)

• Maternal Acceptability (Modified System Usability Scale)

  Implementation Outcome Variable. 14-item scale, rated on a 1-5 response scale. Will examine perceived helpfulness of Mom-Net content, activities, and coach calls. This scale has been used in investigators' prior Mom-Net research. The summed-item total score will be used, with a scale range of 14-70.

  Post intervention ( 5 months)

• Screening Reach (Reach)

  Implementation Outcome. Screening rates will be calculated as the number of PHQ-9 screeners administered within each agency each year divided by the family HS enrollment (with a female-identified parent-figure). The metric will represent the percentage of mothers in each agency who were reached, with a range of 0-100.

  End of screening in year 2 of implementation

• Implementation Reach (IReach)

  Implementation Outcome. Calculated as the number of Mom-Net eligible mothers screened within each agency divided by the number of mothers within each agency initiating Mom-Net intervention with a within-agency range of 0-100%.

  End of Implementation in Year 2

• Maternal Engagement (Engage)

  Number of modules (0-8) and coach calls completed, page views (0-120), and program visits (0- no upper limit). These well-established indices of usage will be collected in real time.

  Change between base-line and 5-month assessments

Secondary Outcomes (10)

• Parent Behavior Inventory (PBI)

  Change between Baseline and 5- and 12-month follow-up

• Parenting Sense of Competence (PSOC)

  Change between Baseline and 5- and 12-month follow-up

• Child Behavior Checklist (CBCL 1 ½ - 5 years)

  Change between Baseline and 5- and 12-month follow-up

• Child Behavior Checklist Teacher Report Form (C-TRF)

  Change between Baseline and 5- and 12-month follow-up

• Aggressive Interpersonal Behavior (Proportion)

  Change between Baseline and 2-4 month assessment

Study Arms (2)

Mom-Net

EXPERIMENTAL

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.

Behavioral: Mom-Net

Treatment as Usual/Waitlist

ACTIVE COMPARATOR

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.

Combination Product: Treatment as Usual/Waitlist

Interventions

Mom-Net BEHAVIORAL

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.

Mom-Net

Treatment as Usual/Waitlist COMBINATION_PRODUCT

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

Treatment as Usual/Waitlist

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- 2-5 years of age and enrolled in participation Head Start

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Springfield, Oregon, 97477, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Therapeutics; Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Edward G Feil, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward G Feil, Ph.D.

CONTACT

541-484-2123; Edf@ori.org

Kendra E Guinness, Ph.D.

CONTACT

541-484-2123; kguinness@ori.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Head Start (HS) agencies will be randomized to offer Mom-Net with either high- or low- intensity coaching. Subsequently, participants will be randomized to either the Mom-Net condition offered by their child's HS agency or to Treatment as Usual within the community/Waitlist (TAU/WL). Assessments will be conducted at T1- prior to participant randomization, at T2- subsequent to the conclusion of the intervention period, and at T3 1 year after T1. Subsequent to the T2 assessments, participants in the TAU/WL condition will be offered the opportunity to participate in the Mom-Net version offered by their HS agency. The T3 assessment will thus enable us to examine Maintenance of effects for those in the Mom-Net condition, and Replication of Mom-Net within group effects for those in the TAU/WL condition.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: December 2, 2021
• Study Start: December 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be loaded into NDA every 6 months once recruitment begins.
• Access Criteria: Compliant with NIMH NDA requirements

Locations

US (1)