Psychological StressPSIPNCT01110343
Conventional vs Mindfulness Intervention in Parents of Children With Disabilities
A study testing mindfulness intervention and Conventional parent Support Group in people with Psychological Stress and Depression, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 to 85 years
- Conditions the study is for
- Psychological Stress, Depression, Anxiety
- What is being tested?
- mindfulness intervention and Conventional parent Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- those who are not parent of a child with a known developmental disorder or medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Stress, Depression, Anxiety
- Being tested
- mindfulness intervention, Conventional parent Support Group
- Keywords
- parent stress, parent coping, parent anxiety, parent health, parent depression
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness interventionBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional parent Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This standardized self report measure will determine if the treatment arms differ in effectiveness and whether overall depression symptoms are alleviated with treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: on day 1 of week 6, active intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Elisabeth Dykens, Vanderbilt University
- Investigators
- Elisabeth M Dykens, PHD, Principal investigator, Vanderbilt Kennedy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110343
- Sponsor's protocol ID
- 090965
- Other IDs
- 1RC1AT005612-01
- Acronym
- PSIP
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities
- ClinicalTrials.gov ID
- NCT01110343
- Acronym / sponsor ID
- PSIP / 090965
- Conditions
- Psychological Stress, Depression, Anxiety
- Keywords
- parent stress, parent coping, parent anxiety, parent health, parent depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness intervention group | Active comparator | Behavioral: mindfulness interventionMindfulness 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. |
| conventional parent support group | Active comparator | Behavioral: Conventional parent Support Groupa 6 week behavioral program, with weekly 1.5 hour sessions with a trained parent mentor, 3 monthly booster sessions and follow-up. |
Who may qualify
- Ages
- 17 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- those who are not parent of a child with a known developmental disorder or medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness interventiona 6 -week behavioral intervention lasting 1.5 hours per week with a trained parent mentor, 3 monthly booster sessions and follow-up | Behavioural | mindfulness intervention group |
| Conventional parent Support Groupa 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. | Behavioural | conventional parent support group |
Primary outcome
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.
4 secondary outcomes
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
Beck Anxiety Inventory
Time frame: at day one of week 6, active intervention phase
Salivary Cortisol measures
Time frame: at day 1 of week 6, active intervention phase
Ryff's scale of Well-being
Time frame: on day 1 of week 6, active intervention phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
Related trials for Psychological Stress
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth M Dykens, PHD principal investigator
Vanderbilt Kennedy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness intervention and Conventional parent Support Group in people with Psychological Stress and Depression, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress Index Scores (time frame: day 1 of week 6, active intervention phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.