Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

NCT04092010 | Recruiting DMC

• 2 other identifiers: 20220033981R01HD092456-01A1
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

Conditions

Maternal Depression

Keywords

Stepped care intervention; Problem solving education; Engagement session; Head Start; Preschool children

Outcome Measures

Primary Outcomes (2)

• Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS

  The Quick Inventory of Depressive Symptoms (QIDS) will be used to assess the incidence of moderate to severe depressive symptom episodes, as defined by a QIDS score ≥ 11. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms.

  Baseline, 2, 4, 6, 8, 10, 12 months follow-up

• Change in the mean maternal depressive symptoms based on the QIDS

  The Quick Inventory of Depressive Symptoms will be used to assess depressive symptoms. The QIDS is a 16 item self-administered instrument with potential responses for each item of 0 to 3. Higher scores are associated with greater depressive symptoms. The mean QIDS scores will be calculated for the baseline and each follow up period.

  Baseline, 2, 4, 6, 8, 10, 12 months follow-up

Secondary Outcomes (14)

• Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription

  Baseline, 2, 4, 6, 8, 10, 12 months follow-up

• Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription

  2, 4, 6, 8, 10, 12 months

• Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription

  2, 4, 6, 8, 10, 12 months

• Rate of participants who received primary-care based services

  2, 4, 6, 8, 10, 12 months

• Burden of illness for depression

  baseline; 6, 12 months

Study Arms (2)

Stepped-care intervention (SCI) group

EXPERIMENTAL

In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.

Behavioral: Problem-solving education (PSE); Behavioral: Engagement sessions

Usual care control group

ACTIVE COMPARATOR

Families in the control group will receive usual Head Start services.

Behavioral: Usual care

Interventions

Problem-solving education (PSE) BEHAVIORAL

PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.

Stepped-care intervention (SCI) group

Engagement sessions BEHAVIORAL

Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)

Stepped-care intervention (SCI) group

Usual care BEHAVIORAL

Normal services provided children and their mothers in Head Start

Usual care control group

Eligibility Criteria

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

You may qualify if:

• Mother of a 0 to 5-year-old Head Start child
• Mother speaks English or Spanish

You may not qualify if:

• Mother with suicidal ideation
• Mother with cognitive limitation

Sponsors & Collaborators

• Brown University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Boston Medical Center: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02119, United States

RECRUITING

Study Officials

• Emily Feinberg, ScD CPNP

  Brown University

  PRINCIPAL INVESTIGATOR

• Michael Silverstein, MD

  Brown University

  PRINCIPAL INVESTIGATOR

• Amy Yule, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Yule, MD

CONTACT

(617) 414-1936; amy.yule@bmc.org

Jocelyn Antonio, MPH

CONTACT

401-863-2259; Jocelyn_antonio@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: August 16, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 6 months after study completion and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for the purposes of reviewing proposals to gain access to these data. Requestors will need to provide a methodologically sound proposal, sign a data sharing agreement, and agree to the terms of data receipt.

Locations

US (1)