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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01021384
Other study ID # H-28799
Secondary ID
Status Completed
Phase Phase 3
First received November 25, 2009
Last updated April 26, 2013
Start date September 2009
Est. completion date March 2013

Study information

Verified date April 2013
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date March 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Medical Center HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quick Inventory of Depressive Symptoms Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months Yes
Primary Parenting Stress Index Baseline, 3, 6 & 9months No
Primary Perceived Stress Scale Baseline, 3, 6 & 9 months No
Secondary Social Problem Solving Inventory Baseline, 3, 6 & 9 months No
Secondary Social Adjustment Scale Self-Report Baseline, 3, 6 & 9 months No
Secondary Patient Activation Measure Baseline, 3, 6 & 9 months No
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