Text Size

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

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
Emily Feinberg, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01021384
First received: November 25, 2009
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  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 Blind (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:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Quick Inventory of Depressive Symptoms [ Time Frame: Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months ] [ Designated as safety issue: Yes ]
  • Parenting Stress Index [ Time Frame: Baseline, 3, 6 & 9months ] [ Designated as safety issue: No ]
  • Perceived Stress Scale [ Time Frame: Baseline, 3, 6 & 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Problem Solving Inventory [ Time Frame: Baseline, 3, 6 & 9 months ] [ Designated as safety issue: No ]
  • Social Adjustment Scale Self-Report [ Time Frame: Baseline, 3, 6 & 9 months ] [ Designated as safety issue: No ]
  • Patient Activation Measure [ Time Frame: Baseline, 3, 6 & 9 months ] [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Emily Feinberg, Associate Professor, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01021384     History of Changes
Other Study ID Numbers: H-28799
Study First Received: November 25, 2009
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Depressive Disorder
Child Development Disorders, Pervasive
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on June 18, 2013