Conventional vs Mindfulness Intervention in Parents of Children With Disabilities (PSIP)
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|ClinicalTrials.gov Identifier: NCT01110343|
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Psychological Stress Depression Anxiety||Behavioral: mindfulness intervention Behavioral: Conventional parent Support Group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: mindfulness intervention group
Mindfulness intervention is a formatted curriculum based on Mindfulness based stress reduction techniques which have proven effective in reducing stress related to pain, everyday living and medical and psychiatric disorders.
Behavioral: mindfulness intervention
a 6 -week behavioral intervention lasting 1.5 hours per week with a trained parent mentor, 3 monthly booster sessions and follow-up
Active Comparator: conventional parent support group
a 6 week behavioral program, with weekly 1.5 hour sessions with a trained parent mentor, 3 monthly booster sessions and follow-up.
Behavioral: Conventional parent Support Group
a 6 week behavioral program, consisting of 1.5 hour weekly sessions run by a trained parent mentor with a structured curriculum based on the strengths of support groups like emotional support, advocacy and training. There are 3 monthly booster sessions and follow-up.
- 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.
- 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 [ Time Frame: at day 1 of week six -active intervention phase ]This standardized self report measure will determine if the treatment arms differ in effectiveness and whether overall depression symptoms are alleviated with treatment.
- Beck Anxiety Inventory [ Time Frame: at day one of week 6, active intervention phase ]This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.
- Salivary Cortisol measures [ Time Frame: at day 1 of week 6, active intervention phase ]Diurnal salivary cortisol measures will show differences to 2 arms of treatment intervention after 6 weeks of active intervention.
- Ryff's scale of Well-being [ Time Frame: on day 1 of week 6, active intervention phase ]This self report measure of well-being will show treatment effects of interventions on week 6.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110343
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Elisabeth M Dykens, PHD||Vanderbilt Kennedy Center|