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
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
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
NCT ID
NCT04092010
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
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.
Learn more about this trial
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
We'll reach out to this number within 24 hrs