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Clinical Trials/NCT01021384
NCT01021384
Completed
Phase 3

Supporting the Well Being of Families of Young Children With Autism Spectrum

Boston Medical Center1 site in 1 country122 target enrollmentSeptember 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Maternal Depression
Sponsor
Boston Medical Center
Enrollment
122
Locations
1
Primary Endpoint
Quick Inventory of Depressive Symptoms
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
March 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Feinberg

Associate Professor

Boston Medical Center

Eligibility Criteria

Inclusion Criteria

  • all mothers of young children \</ 6 with ASDs
  • mothers who speak English or Spanish

Exclusion Criteria

  • Mother has psychosis
  • Mother endorses suicidal ideation
  • Mother actively using illicit drugs
  • Mother expected to leave area within 6 months

Outcomes

Primary Outcomes

Quick Inventory of Depressive Symptoms

Time Frame: Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months

Parenting Stress Index

Time Frame: Baseline, 3, 6 & 9months

Perceived Stress Scale

Time Frame: Baseline, 3, 6 & 9 months

Secondary Outcomes

  • Social Problem Solving Inventory(Baseline, 3, 6 & 9 months)
  • Social Adjustment Scale Self-Report(Baseline, 3, 6 & 9 months)
  • Patient Activation Measure(Baseline, 3, 6 & 9 months)

Study Sites (1)

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