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

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorOregon Research Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

No exclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Treatment as Usual/Waitlist

    Behavioral

    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 groups

960 Participants
are divided into 2 treatment groups
Group A: Mom-NetExperimental treatment 1 intervention
Group B: Treatment as Usual/WaitlistActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessing change between baseline, post-intervention (5 months), and follow up (12 months)
2

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.

Time frame
Post intervention ( 5 months)
3

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.

Time frame
End of screening in year 2 of implementation
4

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%.

Time frame
End of Implementation in Year 2

Secondary outcomes

1

Parent Behavior Inventory (PBI)

Subscales will all be used to examine change in maternal behavior from baseline through subsequent assessment points; subscale total scores will be used; all items rated on a 0 (I don't do this) to 5 (I often do this) scale and summed for subscale total; Supportive/Engaged sub-scale range 0-55, Hostile/Coercive subscale range 0-45.

Time frame
Change between Baseline and 5- and 12-month follow-up
2

Parenting Sense of Competence (PSOC)

Will use will three metrics to assess change in maternal sense of competence from Baseline through subsequent assessments: Total score, 17 items; Efficacy subscale, 8 items, Valuing/Comfort subscale, 9 items; all items are rated on a 1 (Strongly Agree) to 6 (Strongly Disagree) scale. Items will be summed to form: Total score (range of 17-102), Efficacy score (range 4-48) and Valuing/Comfort score (range 9-54). For total and subscale scores, a high score will reflect strong competence.

Time frame
Change between Baseline and 5- and 12-month follow-up
3

Child Behavior Checklist (CBCL 1 ½ - 5 years)

Well-established measure of child internalizing/externalizing behavior; all items rated on 0 (not true), 1 (somewhat or sometimes true), 2 (very true or often true) scale; Both the Internalizing (36 items) and externalizing (24 items) subscales will be used, with raw score ranges of 0-72 and 0-48, respectively. Raw scores will be used in analysis of the age-associated t-scores.

Time frame
Change between Baseline and 5- and 12-month follow-up
4

Child Behavior Checklist Teacher Report Form (C-TRF)

Well-established measure used to examine change in child internalizing/externalizing behavior; all items rated on 0 (not true), 1(somewhat or sometimes true), 2 (very true or often true) scale; Both the internalizing (32 items) and externalizing (34 items) subscales will be used, with raw score ranges of 0-64 and 0-68, respectively. Will be used in analysis of the t-scores associated with the raw score totals.

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

Other outcomes

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