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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01021384
Enrollment
122
Registered
2009-11-30
Start date
2009-09-30
Completion date
2013-03-31
Last updated
2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Depression

Keywords

Depression,, Early Intervention,, Behavior Disorder,, Parenting Skills,, Children with Special Health Care Needs,, Developmental Disabilities,, Family Support Programs

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.

Interventions

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.

Sponsors

HRSA/Maternal and Child Health Bureau
CollaboratorFED
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Quick Inventory of Depressive SymptomsBaseline, 1.5, 3, 4.5, 6, 7.5 & 9 months
Parenting Stress IndexBaseline, 3, 6 & 9months
Perceived Stress ScaleBaseline, 3, 6 & 9 months

Secondary

MeasureTime frame
Social Problem Solving InventoryBaseline, 3, 6 & 9 months
Social Adjustment Scale Self-ReportBaseline, 3, 6 & 9 months
Patient Activation MeasureBaseline, 3, 6 & 9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026