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

NCT ID: NCT01021384

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Maternal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Problem Solving Education

Group Type: OTHER

Problem Solving Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HRSA/Maternal and Child Health Bureau

FED

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Emily Feinberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24217336 (View on PubMed)

Other Identifiers

H-28799

Identifier Type: -

Identifier Source: org_study_id