Clinical trial NCT01021384: Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders
Official title: Supporting the Well Being of Families of Young Children With Autism Spectrum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Maternal Depression
Keywords: Depression,
Early Intervention,
Behavior Disorder,
Parenting Skills,
Children with Special Health Care Needs,
Developmental Disabilities,
Family Support Programs
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2009-11-30
Enrollment: 122
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Quick Inventory of Depressive Symptoms
timeFrame: Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months
measure: Parenting Stress Index
timeFrame: Baseline, 3, 6 & 9months
measure: Perceived Stress Scale
timeFrame: Baseline, 3, 6 & 9 months
Secondary outcomes:
measure: Social Problem Solving Inventory
timeFrame: Baseline, 3, 6 & 9 months
measure: Social Adjustment Scale Self-Report
timeFrame: Baseline, 3, 6 & 9 months
measure: Patient Activation Measure
timeFrame: Baseline, 3, 6 & 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
References:
citation: 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.