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NCT01021384 · ClinicalTrials.gov registry record · Phase 3
Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders
A Phase 3 study of Maternal Depression, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
- 1
- Study location
NCT01021384 is a Phase 3 study of Maternal Depression that has completed, run by Boston Medical Center. The registered enrollment target is 122 participants, below the 776-participant average among 5 other Maternal Depression trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01021384, a Phase 3 study of Maternal Depression, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this 2 year research project is to determine whether an evidenced-based empowerment strategy, Problem Solving Education (PSE), targeted to mothers of young children with autism spectrum disorders (ASDs), promotes family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning. We propose a randomized control trial involving 140 mothers who have children \<4 years with confirmed ASDs. Based on the paradigm of the IOM report on mental health prevention research that highlights the importance of targeting interventions to at-risk populations who may not meet diagnostic criteria, all mothers of young children with ASDs will be eligible to participate. Consistent with previous studies of cognitive-behavioral interventions, the mother-child pairs will be followed for 9 months. The intervention will be embedded in two settings that provide services to young children with ASDs - Early Intervention (EI) programs and specialty developmental assessment clinics. We aim to support families during a critical juncture - when they are confronted with a new diagnosis and are asked to navigate a complex service system on their children's behalf. The hypothesis of this proposal is that strengthening problem solving skills among mothers of young children with ASDs serve as an important buffer against the negative impact of life stressors, and thereby prevent and attenuate depressive symptoms and parenting stress.
Conditions Studied
Interventions
- BEHAVIORAL Problem Solving Education
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01021384
The ClinicalTrials.gov registry entry for NCT01021384 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 776-participant average among 5 other Maternal Depression trials with a reported enrollment target (84% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Maternal Depression appearing as the primary indexed condition, and to 1 intervention - of which Problem Solving Education is the first listed.
NCT01021384 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01021384 about?
NCT01021384 is a clinical study titled "Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders". The objective of this 2 year research project is to determine whether an evidenced-based empowerment strategy, Problem Solving Education (PSE), targeted to mothers of young children with autism spectrum disorders (ASDs), promotes family well-being by decreasing the burden of maternal depressive symp...
What is the current status of trial NCT01021384?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2009-09. Estimated completion is 2013-03.
What conditions does trial NCT01021384 study?
This clinical trial studies the following conditions: Maternal Depression.
What interventions are being tested in trial NCT01021384?
The interventions under investigation include: Problem Solving Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01021384?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01021384 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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