Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant and new parents of infants with Down syndrome (MBDS). Background: Expectant and new parents of infants with Down syndrome are at high risk for perinatal depression. Perinatal depression is both independently, and exponentially associated with long-term adverse neurodevelopmental consequences for infants with Down syndrome. MB is a cognitive-behavioral intervention designed to prevent perinatal depression. MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effects sizes found across a series of randomized controlled trials (RCTs). However, research suggests that expectant and new parents of children with Down syndrome may have needs that standard MB does not address. Significance: This project will pilot a Down syndrome adaptation to MB, MBDS designed to target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant. Innovation: The proposed project is innovative in three ways. First, the investigators plan to conduct the first pilot of a perinatal depression prevention intervention specifically designed for expectant and new parents of infants with Down syndrome. Second, the investigators plan to include fathers, nonbinary, and transgender parents to target symptoms of depression, rather than as simply a support person for maternal depressive symptom reduction. Third, the investigators plan to use a group format to establish cohorts of families of infants with Down syndrome of similar developmental stages. Design: Human-centered design and an open trial will inform a subsequent small randomized controlled clinical pilot to test the feasibility of the study protocol in preparation for a larger randomized controlled trial (RCT). Population: New and expectant parents of infants with Down syndrome. Outcomes: All aspects of the study protocol (e.g., condition allocation, treatment and control condition procedures, data collection, etc.) will be operationalized in preparation for the subsequent RCT. The investigators will assess MBDS effectiveness on target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant.
Age 18 years or older
Expecting or parenting an infant with Down Syndrome (20 months gestation - 4 months old)
Speaks and Reads English
Has access to internet and videoconferencing
Active suicide ideation indicated on any of the following: endorsement of BDI-II item 9, PHQ-9 item 9; PGS-Diagnosis item 3 Subscale II; statements to research staff); or
BDI-II total score ranging from 20 - 63 indicating the participant endorses moderate to severe depressive symptoms and has a higher need for mental health services.
Parallel
Mothers and Babies
BehavioralThe Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.
Mothers and Babies Down Syndrome
BehavioralThe investigators will test new Down syndrome content embedded within the standard Mothers and Babies content. The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.
Perinatal Grief Scale - Diagnosis
The Perinatal Grief Scale-Diagnosis (PGS-D), the NIH Toolkit Emotion Support Test and NIH Toolkit Instrumental Support Test.31 The PGS-D was adapted from the Perinatal Grief Scale,32 a 33-item self-report measure used to assess the intensity of grief following perinatal loss. The PDGS is a 33-item self-report measure used to assess the intensity of grief following receipt of a diagnosis of Down Syndrome for their infant. Participants are asked to indicate their current level of agreement for each statement. Items are rated on a 5-point Likert type scale (0 = strongly agree to 5 = strongly disagree). A total score is determined by summing the ratings for all items. Total scores range from 33 to 165, with higher scores indicating more intense grief. The PGS also consists of 3 subscales: active grief, difficulty coping, and despair. Each subscale score ranges from 11 to 55.
Beck Depression Inventory - 2
The Beck Depression Inventory - II (BDI-II)33 is a 21-item self-report measure used to assess depressive symptoms in adults. Participants are asked to indicate which statement best describes how they felt during the past two weeks including today. Items are rated on a 4-point scale. A total score is determined by summing the ratings for all items. Total scores range from 0 to 63, with higher scores indicating greater depressive symptoms. Total scores ranging from 0 to 13 indicate minimal depressive symptoms, total scores ranging from 14 to 19 indicate mild depressive symptoms, total scores ranging from 20 to 28 indicate moderate depressive symptoms, and total scores ranging from 29 to 63 indicate severe depressive symptoms. The BDI-II has demonstrated high internal consistency (α = 0.91),34 acceptable test-retest reliability,35 strong convergent validity,33 and strong discriminant validity.
The Emotion Support Test
The Emotion Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer-adaptive self- report measure used to assess the perception that people in one's social network are available to listen to one's problems with empathy, caring, and understanding. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 4 = always). Raw scores are converted into a T-Score, with higher scores indicating more emotional support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of emotional support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of emotional support.
The Instrumental Support Test
The Instrumental Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer- adaptive self-report measure used to assess the perception that people in one's social network are available to provide material or functional aid in completing daily tasks if needed. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 5 = always). Raw scores are converted into a T-Score, with higher scores indicating more reported support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of instrumental support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of instrumental support.
Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale
The Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale is a 76-item observer report measure used to assess caregiver behavior and regulation towards their infant in typical daily interactions. Participants are asked to indicate the occurrence vs. non-occurrence of specific behaviors. Items are rated on a binary scale (0= no, 1 = yes). A total score is determined by summing ratings for all items. Total scores range from 0 to 76, with higher scores indicating more favorable parent-child interaction quality. The NCAST PCI Feeding Scale consists of 5 subscales: sensitivity to cues (scores range from 0 to 16), response to child's distress (scores range from 0 to 11), social-emotional growth fostering (scores range from 0 to 14), cognitive growth fostering (scores range from 0 to 9), clarity of cues (scores range from 0 to 10), and responsiveness to caregiver (scores range from 0 to 13).
Patient Health Questionnaire- 9
The PHQ-2 is a brief self-report screening measure for depressive symptoms consisting of two items rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). These items are drawn from the longer PHQ-9 and were selected because they capture the core diagnostic features of depression: depressed mood and anhedonia. The PHQ-2 is widely used as an initial screening tool to identify individuals who may be experiencing major depression (Levis et al., 2020).
Generalized Anxiety Disorder - 7
The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-report questionnaire designed to measure the severity of generalized anxiety disorder. It assesses symptoms, such as uncontrollable worry, restlessness and other symptoms of anxiety experienced over the past two weeks. Response options are provided on a 4-point Likert-type scale (0-3), representing the number of days experiencing symptoms. Higher scores indicate higher levels of anxiety.
The World Health Organization Disability Assessment Schedule 2.0
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item (or 12-item), self-administered, or interviewer-guided questionnaire used to measure health and disability across cultures. It assesses functioning over the past 30 days in six domains: cognition, mobility, self-care, getting along, life activities, and participation.
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Northwestern University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
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