Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Maternal Depression Clinical Trial

Official title:

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092010
• Other study ID #: 2022003398
• Secondary ID: 1R01HD092456-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: Brown University
• Contact: Amy Yule, MD
• Phone: (617) 414-1936
• Email: amy.yule[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Maternal Depression

Intervention

Behavioral:
• Problem-solving education (PSE)
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
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
Normal services provided children and their mothers in Head Start

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Boston Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline, 2, 4, 6, 8, 10, 12 months follow-up
Secondary	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.	2, 4, 6, 8, 10, 12 months
Secondary	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.	2, 4, 6, 8, 10, 12 months
Secondary	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.	2, 4, 6, 8, 10, 12 months
Secondary	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	baseline; 6, 12 months
Secondary	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.	baseline; 6, 12 months
Secondary	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.	baseline; 6, 12 months
Secondary	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.	baseline; 6, 12 months
Secondary	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.	baseline; 6, 12 months
Secondary	Perceived Stress	Assess with The Perceived Stress Scale, domains of which include unpredictability, lack of control, burden overload, and stressful circumstances.	baseline, 4, 8, 12 months
Secondary	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.	baseline, 4, 8, 12 months
Secondary	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.	baseline, 4, 8, 12 months
Secondary	Parent-Child Interaction	Assess with The Dyadic Parent-Child Interaction Coding System (4th Edition).	baseline, 6, 12 months
Secondary	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.	Baseline, 6, 12 months