Clinical trial NCT05142384: ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start
Official title: ICBT for Maternal Depression: Community Implementation in Head Start
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 960
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: Background:

Low income women of childbearing age are at disproportionate risk for depressive syndromes and, despite the availability of efficacious interventions, often do not receive needed treatment. The investigators developed Mom-Net, a remote, coach-facilitated, Internet-based intervention adapted from an empirically-supported cognitive behavioral treatment (CBT) for depression to address the needs of depressed mothers. Two randomized control trials demonstrated Mom-Net to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment. In this project investigators seek to examine whether the reach of the Mom-Net intervention can be expanded by implementing within the Head Start Environment.

Investigators are using a hybrid type 2, Effectiveness-Implementation design to compare two implementation approaches for the delivery of Mom-Net, one with its existing high-intensity coaching approach, and one making use of a low-intensity coaching, designed to provide supportive accountability, but not psychoeducational support. Investigators will follow the Exploration, Preparation, Implementation, and Sustainment process model (EPIS) to guide the evaluation, with the Clinical Trial component primarily constituting the Implementation phase.

Clinical Trial Aims:

1. Examine effectiveness and Implementation outcomes of Mom-Net within Head-Start, randomizing agencies to implementation approach (i.e., high- vs low-intensity coaching) and mothers within agency, to either Mom-Net or Treatment as Usual (TAU)/waitlist conditions.

   1. Compare the two Mom-Net implementation approaches on: 1) implementation outcomes including reach, acceptability, fidelity, and cost; and 2) effectiveness outcomes including self-reported maternal depressive symptoms (primary outcome), parenting behavior, and child emotional and behavioral functioning (secondary outcomes).
   2. Examine the effectiveness of each Mom-Net implementation approach relative to TAU on the primary and secondary outcomes listed above.
2. Consistent with an experimental therapeutic approach, investigators will examine the mediating influence of changes in maternal functioning associated with core Mom-Net skills on maternal depressive symptoms. Mediators to be examined include behavior activation, negative cognitive styles, social support, and belief that mood can be regulated. Investigators will also examine the mediating influence of change in maternal depressive symptoms on parenting behavior and child outcomes.

Clinical Trial Protocol

1. Prior to the Implementation Phase (i.e., clinical trial), participating agencies will be randomized to either high- or low-intensity coaching conditions.

Eligibility 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Assessing change between baseline, post-intervention (5 months), and follow up (12 months)
measure: Maternal Acceptability (Modified System Usability Scale)
timeFrame: Post intervention ( 5 months)
measure: Screening Reach (Reach)
timeFrame: End of screening in year 2 of implementation
measure: Implementation Reach (IReach)
timeFrame: End of Implementation in Year 2
measure: Maternal Engagement (Engage)
timeFrame: Change between base-line and 5-month assessments
Secondary outcomes:
measure: Parent Behavior Inventory (PBI)
timeFrame: Change between Baseline and 5- and 12-month follow-up
measure: Parenting Sense of Competence (PSOC)
timeFrame: Change between Baseline and 5- and 12-month follow-up
measure: Child Behavior Checklist (CBCL 1 ½ - 5 years)
timeFrame: Change between Baseline and 5- and 12-month follow-up
measure: Child Behavior Checklist Teacher Report Form (C-TRF)
timeFrame: Change between Baseline and 5- and 12-month follow-up
measure: Aggressive Interpersonal Behavior (Proportion)
timeFrame: Change between Baseline and 2-4 month assessment
measure: Aggressive Interpersonal Behavior (Duration)
timeFrame: Change between Baseline and 2-4 month assessment
measure: Positive Interpersonal Behavior (Proportion)
timeFrame: Change between Baseline and 2-4 month assessment
measure: Positive Interpersonal Behavior (Duration)
timeFrame: Change between Baseline and 2-4 month assessment
measure: The Work and Social Adjustment Scale
timeFrame: Change between Baseline and 2-4 month assessment
measure: 5-item World Health Organization Well-Being Index
timeFrame: Change between Baseline and 2-4 month assessment
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Edward G Feil, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: