Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01110343
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2010-04-13
Brief Title:
Conventional vs Mindfulness Intervention in Parents of Children With Disabilities
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSIP
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1RC1AT005612-01 | NIH | None | httpsreporternihgovquickSearch1RC1AT005612-01 |