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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01110343
First received: April 13, 2010
Last updated: May 7, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Psychological Stress
Depression
Anxiety
Behavioral: mindfulness intervention
Behavioral: Conventional parent Support Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Parenting Stress Index Scores [ Time Frame: day 1 of week 6, active intervention phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: at day 1 of week six -active intervention phase ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 diffferent treatment arms.

  • Salivary Cortisol measures [ Time Frame: at day 1 of week 6, active intervention phase ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This self repert measure of well-being will show treatment effects of interventions on week 6.


Estimated Enrollment: 400
Study Start Date: February 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   17 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110343

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Elisabeth M Dykens, PHD Vanderbilt Kennedy Center
  More Information

No publications provided

Responsible Party: Elisabeth Dykens, Ph.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01110343     History of Changes
Other Study ID Numbers: 090965, 1RC1AT005612-01
Study First Received: April 13, 2010
Last Updated: May 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
parent stress
parent coping
parent anxiety
parent health
parent depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress, Psychological
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 30, 2014