Adapting a depression prevention program for parents of babies with Down syndrome

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are expecting a baby with Down syndrome or parenting a young infant with Down syndrome. It tests a group program meant to prevent depression around birth.

Age

18 years or older

Sex

All sexes can join, including mothers, fathers, nonbinary and transgender parents.

Disease stage

Expecting or parenting an infant with Down Syndrome, from 20 months gestation to 4 months old (as written in the record).

Main reasons for not taking part

• Active thoughts of suicide shown on the screening questions
• Not able to speak and read English
• No access to internet and video calls
• People can be withdrawn if a BDI-II depression score of 20 - 63 shows moderate to severe depression

The registry criteria, word for word

What the trial wants to find out

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.

The 3 groups in the trial

• Standard Mothers & BabiesExisting treatment, for comparison

  The standard 9-session Mother's and Babies intervention

  Treatment: Mothers and Babies and Mothers and Babies Down Syndrome

• Mothers and Babies Down SyndromeTreatment being tested

  The standard 9-session Mother's and Babies content plus Down Syndrome specific content

  Treatment: Mothers and Babies

• Treatment as UsualsNo study treatment, for comparison

  Parents will receive treatment as Usual