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

ICBT for Maternal Depression: Community Implementation in Head Start

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Head Start agencies can offer Mom-Net, an online program that helps mothers with depression learn ways to change thoughts and behaviors. It compares more and less live coaching by Head Start staff, and Mom-Net with referrals for usual mental health care. The study is for mothers with depression symptoms who have a child ages 2–5 in a participating Head Start.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Mothers must score 10 or higher on either of two depression screening forms: the PHQ or EPDS.
  • Mothers must have a child ages 2–5 enrolled in a participating Head Start.
  • Mothers must be able to communicate in English or Spanish.
  • Children must be ages 2–5 and enrolled in a participating Head Start.

Who can't join

  • Mothers cannot join if they have psychosis (trouble knowing what is real), another major mental illness, or a thinking or learning disability that prevents them from taking part meaningfully.
  • Mothers cannot join if they score 3 on the last question of the PHQ-9 or EPDS, showing frequent thoughts of suicide. They may join later if this risk goes down.
  • There are no exclusion rules for children.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

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