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

Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Psychological Stress
• Intervention / Treatment: Behavioral: mindfulness intervention; Behavioral: Conventional parent Support Group

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1 of week 6, active intervention phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at day 1 of week six -active intervention phase
Beck Anxiety Inventory	This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.	at day one of week 6, active intervention phase
Salivary Cortisol measures	Diurnal salivary cortisol measures will show differences to 2 arms of treatment intervention after 6 weeks of active intervention.	at day 1 of week 6, active intervention phase
Ryff's scale of Well-being	This self report measure of well-being will show treatment effects of interventions on week 6.	on day 1 of week 6, active intervention phase

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Elisabeth M Dykens, PHD, Vanderbilt Kennedy Center

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 26, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: parent stress; parent depression; parent coping; parent anxiety; parent health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Stress, Psychological
• Other Study ID Numbers: 090965; 1RC1AT005612-01 (U.S. NIH Grant/Contract)