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

Maternal Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021384
• Other study ID #: H-28799
• 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

• Maternal Depression

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