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

November 25, 2009
April 26, 2013
September 2009
August 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Quick Inventory of Depressive Symptoms [ Time Frame: Baseline, 2,3, 4, 5, 6 months ] [ Designated as safety issue: Yes ]
  • Parenting Stress Index [ Time Frame: Baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • Perceived Stress Scale [ Time Frame: Baseline, 3, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021384 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Social Problem Solving Inventory [ Time Frame: Baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • Social Adjustment Scale Self-Report [ Time Frame: Baseline, 3, 6 months ] [ Designated as safety issue: No ]
  • Patient Activation Measure [ Time Frame: Baseline, 3, 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders
Supporting the Well Being of Families of Young Children With Autism Spectrum

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Maternal Depression
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.
Problem Solving Education
Intervention: Behavioral: Problem Solving Education
Feinberg E, Augustyn M, Fitzgerald E, Sandler J, Ferreira-Cesar Suarez Z, Chen N, Cabral H, Beardslee W, Silverstein M. Improving maternal mental health after a child's diagnosis of autism spectrum disorder: results from a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):40-6. doi: 10.1001/jamapediatrics.2013.3445.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
March 2013
August 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021384
H-28799
Not Provided
Emily Feinberg, Boston Medical Center
Boston Medical Center
HRSA/Maternal and Child Health Bureau
Not Provided
Boston Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP