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Clinical Trials/NCT01021384
NCT01021384CompletedPhase 3

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

Boston Medical Center1 site in 1 country122 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
122
Locations
1
Primary Endpoint
Quick Inventory of Depressive Symptoms

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Problem Solving Education

Other

Intervention: Problem Solving Education (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emily Feinberg

Associate Professor

Boston Medical Center

Study Sites (1)

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