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NCT Number: NCT01110343

Conventional vs 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.

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Key information

Conditions

Psychological Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress, Psychological

Age range

17 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Parenting Stress Index Scores

    Time frame: day 1 of week 6, active intervention phase

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

Secondary outcomes

  1. 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

    This standardized self report measure will determine if the treatment arms differ in effectiveness and whether overall depression symptoms are alleviated with treatment.

  2. Beck Anxiety Inventory

    Time frame: at day one of week 6, active intervention phase

    This standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.

  3. Salivary Cortisol measures

    Time frame: at day 1 of week 6, active intervention phase

    Diurnal salivary cortisol measures will show differences to 2 arms of treatment intervention after 6 weeks of active intervention.

  4. Ryff's scale of Well-being

    Time frame: on day 1 of week 6, active intervention phase

    This self report measure of well-being will show treatment effects of interventions on week 6.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities

Acronym: PSIP

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2010
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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