Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04092010

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02119, United States

Location status: Recruiting

Location contact

Amy Yule, MD

CONTACT

About this study

This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers.

The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions.

Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Mother with suicidal ideation
  • Mother with cognitive limitation

Treatment and study plan

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.

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)

Usual Care

Behavioral

Normal services provided children and their mothers in Head Start

Primary outcomes

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

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

    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.

  2. Change in the mean maternal depressive symptoms based on the QIDS

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

    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.

Secondary outcomes

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

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

    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into engagement with care. This will be defined as ≥ 1 visit for psychotherapy or pharmacotherapy with a behavioral health specialist (social worker, psychologist, psychiatrist, psychiatric nurse); or a prescription for psychiatric medication from any medical practitioner.

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

    Time frame: 2, 4, 6, 8, 10, 12 months

    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into retention in care. This will be defined as ≥ 4 visit for psychotherapy or pharmacotherapy with a behavioral health specialist (social worker, psychologist, psychiatrist, psychiatric nurse); or a prescription for psychiatric medication from any medical practitioner.

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

    Time frame: 2, 4, 6, 8, 10, 12 months

    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into evidence-based care reflecting either psychotherapy or antidepressant medication.

  4. Rate of participants who received primary-care based services

    Time frame: 2, 4, 6, 8, 10, 12 months

    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into primary care-based services.

  5. Burden of illness for depression

    Time frame: baseline; 6, 12 months

    The Individual Burden of Illness Index for Depression (IBI-D) is a valid and reliable quality of life (QoL) scale, calculated as a composite of the QIDS, the QoL Enjoyment and Satisfaction Questionnaire, and the Work and Social Adjustment Scale

  6. Child absenteeism from Head Start

    Time frame: baseline; 6, 12 months

    Head Start centers will furnish us with monthly absentee rates for all families that provide explicit permission. These will be analyzed as count data against day of eligible attendance.

  7. Caregiver-Teacher Report Form

    Time frame: baseline; 6, 12 months

    This valid and reliable scale will be filled out by Head Start teachers. It measures emotional reactivity, anxiety/depression, somatic complaints, emotional withdrawal, attention problems, and aggressive behavior.

  8. Social Skills Improvement System - Rating Scales

    Time frame: baseline; 6, 12 months

    This valid and reliable scale will be filled out by Head Start teachers. It assesses social skills and problem behaviors for children at risk of interpersonal difficulties.

  9. Bracken School Readiness Assessment

    Time frame: baseline; 6, 12 months

    This scale assesses 85 foundational concepts, including colors, letters, numbers, size/ comparison, and shapes. Assess effect of intervention on child cognitive functioning and school readiness.

  10. Perceived Stress

    Time frame: baseline, 4, 8, 12 months

    Assess with The Perceived Stress Scale, domains of which include unpredictability, lack of control, burden overload, and stressful circumstances.

  11. Behavioral Activation for Depression

    Time frame: baseline, 4, 8, 12 months

    Assess with The Behavioral Activation for Depression Scale (BADS) includes four affective and functional dimensions: activation, avoidance/rumination, work/school impairment, and social impairment.

  12. Coping Strategies

    Time frame: baseline, 4, 8, 12 months

    Assess with The Brief COPE (Coping Orientation to Problems) which measures 14 different adaptive and problematic coping styles. Will also use problem-focused and avoidant subscales.

  13. Parent-Child Interaction

    Time frame: baseline, 6, 12 months

    Assess with The Dyadic Parent-Child Interaction Coding System (4th Edition).

  14. Family Conflict

    Time frame: Baseline, 6, 12 months

    Assess with The 80-item Conflicts and Problem-Solving Scale. Likert scales rate aspects of family conflict known to affect children: 1) number of major and minor conflicts in the past year; 2) family disagreement in 21 areas; 3) frequency of 13 conflict resolution strategies; 4) frequency of 44 conflict tactics.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Yule, MD

CONTACT

[email protected]

(617) 414-1936

Jocelyn Antonio, MPH

CONTACT

[email protected]

401-863-2259

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Boston Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2019
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.