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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021384
First Posted: November 30, 2009
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
Emily Feinberg, Boston Medical Center
  Purpose
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.

Condition Intervention Phase
Maternal Depression Behavioral: Problem Solving Education Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Supporting the Well Being of Families of Young Children With Autism Spectrum

Resource links provided by NLM:


Further study details as provided by Emily Feinberg, Boston Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Social Problem Solving Inventory [ Time Frame: Baseline, 3, 6 & 9 months ]
  • Social Adjustment Scale Self-Report [ Time Frame: Baseline, 3, 6 & 9 months ]
  • Patient Activation Measure [ Time Frame: Baseline, 3, 6 & 9 months ]

Enrollment: 122
Study Start Date: September 2009
Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Problem Solving Education Behavioral: Problem Solving Education
Problem Solving Education (PSE) is an evidenced-based empowerment strategy, targeted to mothers of young children to promote family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021384


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
HRSA/Maternal and Child Health Bureau
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emily Feinberg, Associate Professor, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01021384     History of Changes
Other Study ID Numbers: H-28799
First Submitted: November 25, 2009
First Posted: November 30, 2009
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Emily Feinberg, Boston Medical Center:
Depression,
Early Intervention,
Behavior Disorder,
Parenting Skills,
Children with Special Health Care Needs,
Developmental Disabilities,
Family Support Programs

Additional relevant MeSH terms:
Depression
Autism Spectrum Disorder
Behavioral Symptoms
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders