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Completed

NCT Number: NCT01021384

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quick Inventory of Depressive Symptoms

    Time frame: Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months

  2. Parenting Stress Index

    Time frame: Baseline, 3, 6 & 9months

  3. Perceived Stress Scale

    Time frame: Baseline, 3, 6 & 9 months

Secondary outcomes

  1. Social Problem Solving Inventory

    Time frame: Baseline, 3, 6 & 9 months

  2. Social Adjustment Scale Self-Report

    Time frame: Baseline, 3, 6 & 9 months

  3. Patient Activation Measure

    Time frame: Baseline, 3, 6 & 9 months

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Nov 30, 2009
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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