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Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Primary Purpose

Maternal Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Problem-solving education (PSE)
Engagement sessions
Usual care
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Depression focused on measuring Stepped care intervention, Problem solving education, Engagement session, Head Start, Preschool children

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stepped-care intervention (SCI) group

    Usual care control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription
    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.
    Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription
    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.
    Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription
    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into evidence-based care reflecting either psychotherapy or antidepressant medication.
    Rate of participants who received primary-care based services
    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into primary care-based services.
    Burden of illness for depression
    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
    Child absenteeism from Head Start
    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.
    Caregiver-Teacher Report Form
    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.
    Social Skills Improvement System - Rating Scales
    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.
    Bracken School Readiness Assessment
    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.
    Perceived Stress
    Assess with The Perceived Stress Scale, domains of which include unpredictability, lack of control, burden overload, and stressful circumstances.
    Behavioral Activation for Depression
    Assess with The Behavioral Activation for Depression Scale (BADS) includes four affective and functional dimensions: activation, avoidance/rumination, work/school impairment, and social impairment.
    Coping Strategies
    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.
    Parent-Child Interaction
    Assess with The Dyadic Parent-Child Interaction Coding System (4th Edition).
    Family Conflict
    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.

    Full Information

    First Posted
    September 13, 2019
    Last Updated
    July 5, 2023
    Sponsor
    Brown University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04092010
    Brief Title
    Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
    Official Title
    Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brown University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal Depression
    Keywords
    Stepped care intervention, Problem solving education, Engagement session, Head Start, Preschool children

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    388 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stepped-care intervention (SCI) group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual care control group
    Arm Type
    Active Comparator
    Arm Description
    Families in the control group will receive usual Head Start services.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Problem-solving education (PSE)
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Engagement sessions
    Intervention Description
    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)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual care
    Intervention Description
    Normal services provided children and their mothers in Head Start
    Primary Outcome Measure Information:
    Title
    Change in incident rates of moderate to severe maternal depressive symptoms based on the QIDS
    Description
    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.
    Time Frame
    Baseline, 2, 4, 6, 8, 10, 12 months follow-up
    Title
    Change in the mean maternal depressive symptoms based on the QIDS
    Description
    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.
    Time Frame
    Baseline, 2, 4, 6, 8, 10, 12 months follow-up
    Secondary Outcome Measure Information:
    Title
    Rate of participants engaged with care based on 1 or more psycho/pharmacotherapy visits or psychiatric medication prescription
    Description
    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.
    Time Frame
    Baseline, 2, 4, 6, 8, 10, 12 months follow-up
    Title
    Rate of participants retained in care based on 4 or more psycho/pharmacotherapy visits or psychiatric medication prescription
    Description
    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.
    Time Frame
    2, 4, 6, 8, 10, 12 months
    Title
    Rate of participants who received evidence-based care defined by psychotherapy or antidepressant medication prescription
    Description
    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into evidence-based care reflecting either psychotherapy or antidepressant medication.
    Time Frame
    2, 4, 6, 8, 10, 12 months
    Title
    Rate of participants who received primary-care based services
    Description
    The investigators have adapted the services section of the Collaborative Psychiatric Epidemiology Surveys, operationalized into primary care-based services.
    Time Frame
    2, 4, 6, 8, 10, 12 months
    Title
    Burden of illness for depression
    Description
    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
    Time Frame
    baseline; 6, 12 months
    Title
    Child absenteeism from Head Start
    Description
    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.
    Time Frame
    baseline; 6, 12 months
    Title
    Caregiver-Teacher Report Form
    Description
    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.
    Time Frame
    baseline; 6, 12 months
    Title
    Social Skills Improvement System - Rating Scales
    Description
    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.
    Time Frame
    baseline; 6, 12 months
    Title
    Bracken School Readiness Assessment
    Description
    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.
    Time Frame
    baseline; 6, 12 months
    Title
    Perceived Stress
    Description
    Assess with The Perceived Stress Scale, domains of which include unpredictability, lack of control, burden overload, and stressful circumstances.
    Time Frame
    baseline, 4, 8, 12 months
    Title
    Behavioral Activation for Depression
    Description
    Assess with The Behavioral Activation for Depression Scale (BADS) includes four affective and functional dimensions: activation, avoidance/rumination, work/school impairment, and social impairment.
    Time Frame
    baseline, 4, 8, 12 months
    Title
    Coping Strategies
    Description
    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.
    Time Frame
    baseline, 4, 8, 12 months
    Title
    Parent-Child Interaction
    Description
    Assess with The Dyadic Parent-Child Interaction Coding System (4th Edition).
    Time Frame
    baseline, 6, 12 months
    Title
    Family Conflict
    Description
    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.
    Time Frame
    Baseline, 6, 12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emily Feinberg, ScD CPNP
    Phone
    (617) 414-1425
    Email
    emfeinbe@bu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jocelyn Antonio, MPH
    Phone
    401-863-2259
    Email
    Jocelyn_antonio@brown.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emily Feinberg, ScD CPNP
    Organizational Affiliation
    BU School of Medicine, Pediatrics and BUSPH
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michael Silverstein, MD
    Organizational Affiliation
    Brown University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified individual participant data that underlie the results reported for all primary and secondary outcome measures will be made available (text, tables, figures, and appendices).
    IPD Sharing Time Frame
    Beginning 6 months after study completion and ending 5 years following article publication.
    IPD Sharing 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.

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    Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

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