Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome
This study is looking at a program called Mothers and Babies (MB) to help expectant and new parents of infants with Down syndrome. The MB program uses cognitive-behavioral therapy (CBT) and attachment theory to help with symptoms of depression and stress during pregnancy and after birth. Researchers are testing a new version, called Mothers and Babies Down Syndrome (MBDS), which adds specific content for parents of children with Down syndrome. The goal is to see if this adapted program can help prevent perinatal depression. You might be able to join if you are 18 or older, expecting or parenting an infant with Down syndrome (up to 4 months old), speak and read English, and have internet access. The study will measure changes in grief, depression, and emotional support over about 21 weeks. The current status of the study is unclear, and it plans to enroll 72 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific program. It plans to enroll 72 participants.
- What's involved
- You would participate in 9 virtual, weekly sessions, each lasting 25 minutes. You would also complete assessments at baseline, 5 weeks, 9 weeks, and 21 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 21 weeks after the start of the study, with assessments at specific time points.
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Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Heather J Risser · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Perinatal Grief Scale - DiagnosisBaseline, 5 weeks, 9 weeks, 21 weeks
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 - 2Baseline, 5 weeks, 9 weeks, 21 weeks
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 TestBaseline, 5 weeks, 9 weeks, 21 weeks
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 TestBaseline, 5 weeks, 9 weeks, 21 weeks
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.