Health TrialsbyHealthPanel

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

ConditionMaternal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorBrown University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mother of a 0 to 5-year-old Head Start child

Mother speaks English or Spanish

Disqualifiers

Mother with suicidal ideation

Mother with cognitive limitation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

388 Participants
are divided into 2 treatment groups
Group A: Stepped-care intervention (SCI) groupExperimental treatment 2 interventions
Group B: Usual care control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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.

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

Secondary outcomes

1

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.

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

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.

Time frame
2, 4, 6, 8, 10, 12 months
3

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.

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Boston Medical Center

Collaborator

Source ClinicalTrials.gov
Apply now