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

Study Details

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).

Conditions

Depression

Study ID

NCT05142384

Start date

Dec 1, 2022

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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

Primary outcome measure

Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Assessing change between baseline, post-intervention (5 months), and follow up (12 months) ]
Maternal Acceptability (Modified System Usability Scale) [ Time Frame: Post intervention ( 5 months) ]
Screening Reach (Reach) [ Time Frame: End of screening in year 2 of implementation ]
Implementation Reach (IReach) [ Time Frame: End of Implementation in Year 2 ]
Maternal Engagement (Engage) [ Time Frame: Change between base-line and 5-month assessments ]