Mothers and Babies Program for Depression in Parents of Children With Down Syndrome

(MBDS Trial)

HR
Overseen ByHeather Risser, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special program designed to help prevent depression in expectant and new parents of infants with Down syndrome. The program, called Mothers and Babies Down Syndrome (MBDS), includes specific content to address the unique needs of these parents, focusing on grief, loss, and social support. Researchers aim to determine if this adapted program can effectively reduce depressive symptoms and improve parent-infant interactions. The trial seeks expectant or new parents with an infant with Down syndrome who can access online sessions. As an unphased trial, it offers a unique opportunity for parents to contribute to research that could enhance support systems for similar families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a counseling program for depression, so it's best to discuss your medications with the trial staff or your doctor.

What prior data suggests that the Mothers and Babies program is safe for expectant and new parents of infants with Down syndrome?

Research has shown that the Mothers and Babies (MB) program is safe and effective for helping new and expectant parents manage depression. Studies have found that this program can significantly reduce depression symptoms in pregnant women and new mothers, demonstrating moderate to large positive effects in several well-designed studies.

The Mothers and Babies program employs cognitive-behavioral therapy, which helps individuals change their thoughts and actions to improve emotional well-being. By including specific content for parents of children with Down syndrome, as seen in the MBDS, it addresses unique needs such as coping with grief and finding social support.

Overall, the Mothers and Babies program has a strong track record of being safe and beneficial for parents dealing with depression. Studies have not reported any major negative effects, making it a promising option for those considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Mothers and Babies Program for parents of children with Down syndrome because it offers a tailored approach to managing depression. Unlike standard therapies that may not address the unique challenges faced by these parents, this program includes specific content that directly relates to raising a child with Down syndrome. By integrating Down syndrome-specific material into the proven 9-session Mothers and Babies intervention, this program aims to provide more personalized support, potentially leading to better outcomes for parents. This tailored approach is what sets it apart from traditional depression treatments, which often do not account for the additional emotional and psychological demands of parenting a child with special needs.

What evidence suggests that this trial's treatments could be effective for perinatal depression in parents of infants with Down syndrome?

Research has shown that the standard Mothers and Babies (MB) program effectively prevents depression around childbirth, with significant positive results in many studies. This program helps reduce depression symptoms and prevents new cases of depression in expecting and new parents. In this trial, some participants will receive the standard MB program, while others will receive the Mothers and Babies Down Syndrome (MBDS) program. The MBDS program is specially adapted to meet the needs of parents with children who have Down syndrome, focusing on issues like grief and social support. Although specific data on the MBDS program remains limited, it is based on the successful MB program. Early results suggest that this tailored support may help reduce depression symptoms in this high-risk group.36789

Who Is on the Research Team?

HJ

Heather J Risser

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults (18+) who are expecting or parenting an infant with Down syndrome (from late pregnancy up to the baby being 4 months old). Participants must speak and read English and have internet access for videoconferencing.

Inclusion Criteria

* Expecting or parenting an infant with Down Syndrome (20 months gestation - 4 months old)
I am 18 years old or older.
* Speaks and Reads English
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation and Co-Design

Adaptation of the Mothers and Babies program for parents of infants with Down syndrome using a human-centered design approach

9 weeks
Weekly sessions

Open Trial

Conduct an open trial to assess feasibility and acceptability of the adapted virtual MBDS intervention

9 weeks
Baseline, mid- and post-intervention assessments

Follow-up

Participants are monitored for changes in depressive symptoms and parental sensitivity and responsivity to the infant

12 weeks
3-month post-intervention assessment

What Are the Treatments Tested in This Trial?

Interventions

  • Mothers and Babies
  • Mothers and Babies Down Syndrome

Trial Overview

The study is testing a counseling program called Mothers and Babies, adapted specifically for parents of infants with Down syndrome. It aims to prevent depression by addressing grief, loss, and social support in group sessions delivered online.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Mothers and Babies Down SyndromeExperimental Treatment1 Intervention
Group II: Treatment as UsualsActive Control1 Intervention
Group III: Standard Mothers & BabiesActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Mothers and Babies Program for Depression in Parents of ...

Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant and new parents of infants with Down ...

Down syndrome and parental depression: A double hit ... - PMC

These findings suggest that DS and parental depression may constitute a double hit leading to increased difficulties in the development of expressive language.

Psychological wellbeing in parents of children with Down ...

Parents of children with Down syndrome had elevated stress and depressive symptoms. •. There were no group differences in positive impact of parenting. •.

Families of children with Down syndrome:What we know ...

Studies on parenting efficacy focus on parents' confidence in their ability to fulfil the parenting role and successfully nurture children's development.

Parenting Stress in Mothers of Children and Adolescents with ...

Parents of children with intellectual disability, including Down Syndrome (DS), show higher levels of parenting stress than parents of typically developing ...

Maternal depression and child development - PMC

Social support and home visiting interventions have been successful in improving depressed mothers' moods and attitudes (71,72), as well as their infants' ...

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mothersandbabiesprogram.org

mothersandbabiesprogram.org/research/

Research At Mothers & Babies

Our effective research has shown the impact Mothers & Babies has had on many the mental health of pregnant women and new moms.

Down syndrome and parental depression: A double hit on ...

We found that parental depression is associated with a slower rate of expressive language development in the first four years of life in DS.

Parents' depression impacts their children's mental health

Researchers say that depression has an impact on family life, and that family interventions are needed to treat depression in either parent.