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

Primary Purpose

Maternal Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Problem Solving Education
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Maternal Depression focused on measuring Depression,, Early Intervention,, Behavior Disorder,, Parenting Skills,, Children with Special Health Care Needs,, Developmental Disabilities,, Family Support Programs

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Problem Solving Education

Arm Description

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptoms
Parenting Stress Index
Perceived Stress Scale

Secondary Outcome Measures

Social Problem Solving Inventory
Social Adjustment Scale Self-Report
Patient Activation Measure

Full Information

First Posted
November 25, 2009
Last Updated
April 26, 2013
Sponsor
Boston Medical Center
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT01021384
Brief Title
Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders
Official Title
Supporting the Well Being of Families of Young Children With Autism Spectrum
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression
Keywords
Depression,, Early Intervention,, Behavior Disorder,, Parenting Skills,, Children with Special Health Care Needs,, Developmental Disabilities,, Family Support Programs

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem Solving Education
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms
Time Frame
Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months
Title
Parenting Stress Index
Time Frame
Baseline, 3, 6 & 9months
Title
Perceived Stress Scale
Time Frame
Baseline, 3, 6 & 9 months
Secondary Outcome Measure Information:
Title
Social Problem Solving Inventory
Time Frame
Baseline, 3, 6 & 9 months
Title
Social Adjustment Scale Self-Report
Time Frame
Baseline, 3, 6 & 9 months
Title
Patient Activation Measure
Time Frame
Baseline, 3, 6 & 9 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24217336
Citation
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.
Results Reference
derived

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

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