Clinical trial NCT01110343: Conventional vs Mindfulness Intervention in Parents of Children With Disabilities
Official title: Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Depression
Anxiety
Keywords: parent stress
parent coping
parent anxiety
parent health
parent depression
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-04-26
Enrollment: 243
Sex: ALL
Minimum age (years): 17
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parenting Stress Index Scores
timeFrame: day 1 of week 6, active intervention phase
Secondary outcomes:
measure: 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
timeFrame: at day 1 of week six -active intervention phase
measure: Beck Anxiety Inventory
timeFrame: at day one of week 6, active intervention phase
measure: Salivary Cortisol measures
timeFrame: at day 1 of week 6, active intervention phase
measure: Ryff's scale of Well-being
timeFrame: on day 1 of week 6, active intervention phase
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt Kennedy Center
name: Elisabeth M Dykens, PHD
role: PRINCIPAL_INVESTIGATOR
References: