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

Phase 3

Completed

• Conditions: Maternal Depression
• Interventions: Behavioral: Problem Solving Education

• Registration Number: NCT01021384
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-11-30
• Primary Completion: 2012-08
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-26
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Problem Solving Education	Problem Solving Education	-

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptoms	Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months
Parenting Stress Index	Baseline, 3, 6 & 9months
Perceived Stress Scale	Baseline, 3, 6 & 9 months

Secondary Outcome Measures

Name	Time	Method
Social Problem Solving Inventory	Baseline, 3, 6 & 9 months
Social Adjustment Scale Self-Report	Baseline, 3, 6 & 9 months
Patient Activation Measure	Baseline, 3, 6 & 9 months

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States