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

NCT01021384 | Completed Phase 3

• 1 other identifier: H-28799
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

Problem Solving Education

OTHER

Behavioral: Problem Solving Education

Interventions

Problem Solving Education 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.

Problem Solving Education

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all mothers of young children \</ 6 with ASDs
• mothers who speak English or Spanish

You may not qualify if:

• Mother has psychosis
• Mother endorses suicidal ideation
• Mother actively using illicit drugs
• Mother expected to leave area within 6 months

Sponsors & Collaborators

• Boston Medical Center: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 24217336 DERIVED

MeSH Terms

Conditions

Depression; Mental Disorders; Developmental Disabilities

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)