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Clinical Trials/NCT01110343
NCT01110343
Completed
N/A

Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities

Vanderbilt University1 site in 1 country243 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychological Stress
Sponsor
Vanderbilt University
Enrollment
243
Locations
1
Primary Endpoint
Parenting Stress Index Scores
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This application compares the effectiveness of a conventional Parent Group intervention to Mindfulness- Based Stress Reduction (MBSR) in parents of children with autism spectrum disorders (ASD) and other disabilities. Parent groups are widely-used to provide information, emotional support, education and advocacy. MBSR is efficacious for people with medical, psychiatric or other concerns, and teaches stress reduction through mindfulness training and practice. In contrast to conventional parent groups, the investigators' studies suggest that mindfulness-based interventions may be particularly effective in reducing stress and improving the health and mental health of parents of children with disabilities. The investigators will assess parent factors that may correlate with intervention efficacy in the 2 treatment arms.

Detailed Description

Specific Aim 1. To compare the effectiveness of Parent Groups versus MBSR interventions in parents of children with ASD or other developmental disabilities. Hypothesis 1: Mothers and fathers in both treatment groups will show reduced stress, depression, and anxiety, and increased life satisfaction, health, and well-being. Treatment effects will be more pronounced in MBSR, including more normalized diurnal cortisol patterns. Hypothesis 2: Improved parental outcomes will persist after treatment, and relate to booster session attendance, and/or the frequency that parents practice techniques learned in each treatment. Improvements will be sustained longer in the MBSR treatment. Parental benefits will impact families, and may be associated with improved child behaviors or less family conflict. Hypothesis 3. The composition of intervention groups in Year 2 will be adjusted based on Year 1 data, and may reflect continued separation or integration of ASD vs other disability groups, or new combinations of participants. Specific Aim 2: To identify aspects of maternal, family or child functioning that help explain variability in responses to Parent Group or MBSR interventions. Hypothesis 4: Mothers or fathers with relatively more stress, health or mental health problems, will show more robust treatment responses. Variability in treatment responses may be associated with child age, maternal age, family ethnicity, and child behavior problems. Hypothesis 5. Outcomes may relate to factors in the interventionists, greater treatment responses will be found when parents are matched with peer-mentors of the same gender, ethnicity, and child diagnosis.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
January 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elisabeth Dykens

Director of Vanderbilt Kennedy Center

Vanderbilt University

Eligibility Criteria

Inclusion Criteria

  • parent of a child with a known developmental disorder
  • parent of a child with a chronic medical condition with known lifelong physical and mental effects, e.g., childhood cancer, cystic fibrosis, and muscular dystrophy

Exclusion Criteria

  • those who are not parent of a child with a known developmental disorder or medical condition

Outcomes

Primary Outcomes

Parenting Stress Index Scores

Time Frame: day 1 of week 6, active intervention phase

Parenting Stress Index standard scores will show treatment effects of intervention by day one of week six of active intervention phase.

Secondary Outcomes

  • Beck Depression Inventory, Parenting Stress Index, Epworth Sleep Scale, Positive Affect Index, Life Satisfaction Scale, Mindfulness Questionnaire, Ryff's Well being Scale, Health Questionnaire, Achenbach Child Behavior Checklist(at day 1 of week six -active intervention phase)
  • Beck Anxiety Inventory(at day one of week 6, active intervention phase)
  • Salivary Cortisol measures(at day 1 of week 6, active intervention phase)
  • Ryff's scale of Well-being(on day 1 of week 6, active intervention phase)

Study Sites (1)

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