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Conventional vs Mindfulness Intervention in Parents of Children With Disabilities

Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01110343
Acronym
PSIP
Enrollment
243
Registered
2010-04-26
Start date
2010-02-28
Completion date
2013-01-31
Last updated
2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Psychological Stress

Keywords

parent stress, parent coping, parent anxiety, parent health, parent depression

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.

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.

Interventions

BEHAVIORALmindfulness intervention

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

BEHAVIORALConventional 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Parenting Stress Index Scoresday 1 of week 6, active intervention phaseParenting Stress Index standard scores will show treatment effects of intervention by day one of week six of active intervention phase.

Secondary

MeasureTime frameDescription
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 Checklistat day 1 of week six -active intervention phaseThis standardized self report measure will determine if the treatment arms differ in effectiveness and whether overall depression symptoms are alleviated with treatment.
Beck Anxiety Inventoryat day one of week 6, active intervention phaseThis standardized measure of physiological anxiety symptoms will show treatment effects by week 6 in response to 2 different treatment arms.
Salivary Cortisol measuresat day 1 of week 6, active intervention phaseDiurnal salivary cortisol measures will show differences to 2 arms of treatment intervention after 6 weeks of active intervention.
Ryff's scale of Well-beingon day 1 of week 6, active intervention phaseThis self report measure of well-being will show treatment effects of interventions on week 6.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026