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Conventional vs Mindfulness Intervention in Parents of Children With Disabilities (PSIP)

Primary Purpose

Psychological Stress, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mindfulness intervention
Conventional parent Support Group
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Stress focused on measuring parent stress, parent coping, parent anxiety, parent health, parent depression

Eligibility Criteria

17 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mindfulness intervention group

conventional parent support group

Arm Description

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.

a 6 week behavioral program, with weekly 1.5 hour sessions with a trained parent mentor, 3 monthly booster sessions and follow-up.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.
Salivary Cortisol measures
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
This self report measure of well-being will show treatment effects of interventions on week 6.

Full Information

First Posted
April 13, 2010
Last Updated
June 2, 2015
Sponsor
Vanderbilt University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01110343
Brief Title
Conventional vs Mindfulness Intervention in Parents of Children With Disabilities
Acronym
PSIP
Official Title
Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Depression, Anxiety
Keywords
parent stress, parent coping, parent anxiety, parent health, parent depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mindfulness intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional parent support group
Arm Type
Active Comparator
Arm Description
a 6 week behavioral program, with weekly 1.5 hour sessions with a trained parent mentor, 3 monthly booster sessions and follow-up.
Intervention Type
Behavioral
Intervention Name(s)
mindfulness intervention
Intervention Description
a 6 -week behavioral intervention lasting 1.5 hours per week with a trained parent mentor, 3 monthly booster sessions and follow-up
Intervention Type
Behavioral
Intervention Name(s)
Conventional parent Support Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parenting Stress Index Scores
Description
Parenting Stress Index standard scores will show treatment effects of intervention by day one of week six of active intervention phase.
Time Frame
day 1 of week 6, active intervention phase
Secondary Outcome Measure Information:
Title
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
Description
This standardized self report measure will determine if the treatment arms differ in effectiveness and whether overall depression symptoms are alleviated with treatment.
Time Frame
at day 1 of week six -active intervention phase
Title
Beck Anxiety Inventory
Description
This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.
Time Frame
at day one of week 6, active intervention phase
Title
Salivary Cortisol measures
Description
Diurnal salivary cortisol measures will show differences to 2 arms of treatment intervention after 6 weeks of active intervention.
Time Frame
at day 1 of week 6, active intervention phase
Title
Ryff's scale of Well-being
Description
This self report measure of well-being will show treatment effects of interventions on week 6.
Time Frame
on day 1 of week 6, active intervention phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth M Dykens, PHD
Organizational Affiliation
Vanderbilt Kennedy Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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Conventional vs Mindfulness Intervention in Parents of Children With Disabilities

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