- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092010
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jocelyn Antonio, MPH
- Phone Number: 401-863-2259
- Email: Jocelyn_antonio@brown.edu
Study Contact Backup
- Name: Amy Yule, MD
- Phone Number: (617) 414-1936
- Email: amy.yule@bmc.org
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02119
- Recruiting
- Boston Medical Center
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Contact:
- Amy Yule, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mother of a 0 to 5-year-old Head Start child, whose Head Start services will continue for at least 12 months following randomization
- Mother endorses depressed mood or anhedonia on PHQ-9 (Patient Health Questionnaire-9)
- Mother speaks English or Spanish
- Mother is Medicaid beneficiary
Exclusion Criteria:
- Mother with suicidal ideation
- Mother with cognitive limitation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stepped-care intervention (SCI) group
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.
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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 will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)
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Active Comparator: Usual care control group
Families in the control group will receive usual Head Start services.
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Normal services provided children and their mothers in Head Start
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, 2, 4, 6, 8, 10, 12 months follow-up
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Change in the mean maternal depressive symptoms based on the QIDS
Time Frame: Baseline, 2, 4, 6, 8, 10, 12 months follow-up
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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.
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Baseline, 2, 4, 6, 8, 10, 12 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, 2, 4, 6, 8, 10, 12 months follow-up
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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
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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.
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2, 4, 6, 8, 10, 12 months
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Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription
Time Frame: 2, 4, 6, 8, 10, 12 months
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The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into evidence-based care reflecting either psychotherapy or antidepressant medication.
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2, 4, 6, 8, 10, 12 months
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Rate of participants who received primary-care based services
Time Frame: 2, 4, 6, 8, 10, 12 months
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The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into primary care-based services.
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2, 4, 6, 8, 10, 12 months
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Burden of illness for depression
Time Frame: baseline; 6, 12 months
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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
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baseline; 6, 12 months
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Child absenteeism from Head Start
Time Frame: baseline; 6, 12 months
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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.
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baseline; 6, 12 months
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Caregiver-Teacher Report Form
Time Frame: baseline; 6, 12 months
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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.
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baseline; 6, 12 months
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Social Skills Improvement System - Rating Scales
Time Frame: baseline; 6, 12 months
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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.
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baseline; 6, 12 months
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Bracken School Readiness Assessment
Time Frame: baseline; 6, 12 months
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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.
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baseline; 6, 12 months
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Perceived Stress
Time Frame: baseline, 4, 8, 12 months
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Assess with The Perceived Stress Scale, domains of which include unpredictability, lack of control, burden overload, and stressful circumstances.
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baseline, 4, 8, 12 months
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Behavioral Activation for Depression
Time Frame: baseline, 4, 8, 12 months
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Assess with The Behavioral Activation for Depression Scale (BADS) includes four affective and functional dimensions: activation, avoidance/rumination, work/school impairment, and social impairment.
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baseline, 4, 8, 12 months
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Coping Strategies
Time Frame: baseline, 4, 8, 12 months
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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.
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baseline, 4, 8, 12 months
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Parent-Child Interaction
Time Frame: baseline, 6, 12 months
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Assess with The Dyadic Parent-Child Interaction Coding System (4th Edition).
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baseline, 6, 12 months
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Family Conflict
Time Frame: Baseline, 6, 12 months
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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.
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Baseline, 6, 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Silverstein, MD, Brown University
- Principal Investigator: Amy Yule, MD, Boston Medical Center
- Principal Investigator: Emily Feinberg, ScD CPNP, Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022003398
- 1R01HD092456-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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