Conventional vs Mindfulness Intervention in Parents of Children With Disabilities

Depression Clinical Trial

— PSIP  

Official title:

Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110343
• Other study ID #: 090965
• Secondary ID: 1RC1AT005612-01
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: June 2, 2015
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: April 2010
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Stress
• Stress, Psychological

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No