Conventional vs Mindfulness Intervention in Parents of Children With Disabilities

NCT01110343 | Completed

• 2 other identifiers: 0909651RC1AT005612-01
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Depression; Anxiety

Keywords

parent stress; parent coping; parent anxiety; parent health; parent depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  at day 1 of week six -active intervention phase

• Beck Anxiety Inventory

  at day one of week 6, active intervention phase

• Salivary Cortisol measures

  at day 1 of week 6, active intervention phase

• Ryff's scale of Well-being

  on day 1 of week 6, active intervention phase

Study Arms (2)

mindfulness intervention group

ACTIVE COMPARATOR

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

conventional parent support group

ACTIVE COMPARATOR

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

Interventions

mindfulness intervention BEHAVIORAL

a 6 -week behavioral intervention lasting 1.5 hours per week with a trained parent mentor, 3 monthly booster sessions and follow-up

mindfulness intervention group

Conventional parent Support Group BEHAVIORAL

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.

conventional parent support group

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• those who are not parent of a child with a known developmental disorder or medical condition

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Elisabeth M Dykens, PHD

  Vanderbilt Kennedy Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vanderbilt Kennedy Center

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 26, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 4, 2015

Record last verified: 2010-04

Locations

US (1)