StressNCT02574559
CBCT for Parents of Children With Autism
A study testing Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind, Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience and Cognitive Based Compassion Training Session: Self-compassion in people with Stress, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if caregivers of children with a developmental delay experience a decrease in stress by participating in a meditation/cognitive training protocol. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind, Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience and Cognitive Based Compassion Training Session: Self-compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 11 Feb 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caregiver of child(ren) with developmental delay (including parents, grandparents, other extended family, family friends, and providers)
- Spend significant amount of time (more than 10 hours/week) with children with special needs.
Who cannot join
- Started to use any psychotropic medication within one year.
- Had any changes in any psychotropic medication doses taken within one year.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Cognitively Based Compassion Training for Parents of Children With Autism Spectrum Disorders
The purpose of this study is to determine if caregivers of children with a developmental delay experience a decrease in stress by participating in a meditation/cognitive training protocol.
Read the detailed description
A pilot-test, eight week, Cognitive Based Compassion Training (CBCT) program for caregivers of children with developmental delays that is comprised of eight two-hour weekly long sessions with a certified instructor followed by a twenty minute long meditation session. Sessions will focus on developing attention and stability of mind through focused attention training; cultivating insight into the nature of mental experience; cultivating self-compassion; developing equanimity; developing appreciation and gratitude; developing affection and empathy; realizing aspirational compassion; and realizing active compassion.
- Conditions
- Stress
- Being tested
- Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind, Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience, Cognitive Based Compassion Training Session: Self-compassion, Cognitive Based Compassion Training Session: Cultivating Equanimity, Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
- Keywords
- Caregiver, Stress, Depression, Autism Spectrum Disorder, Compassion Meditation
- Medical subject headings
- Depression, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Based Compassion Training Session: Developing Attention and Stability of MindBehavioural
Completed at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental ExperienceBehavioural
Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
Cognitive Based Compassion Training Session: Self-compassionBehavioural
Completed at Week 3: Techniques to analyze mental processes are introduced.
Cognitive Based Compassion Training Session: Cultivating EquanimityBehavioural
Completed at Week 4. Further analysis of mental processes.
Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for OthersBehavioural
Completed at Week 5. A reflection of all the things that bring us well-being are provided by or dependent upon other beings is encouraged.
Cognitive Based Compassion Training Session: Developing Affection and EmpathyBehavioural
Completed at Week 6. The following concepts are presented and carefully considered: (1) cooperation and solidarity is essential for our survival and flourishing, as we are all extremely vulnerable and need each other; (2) hate and selfishness only cause suffering to others and ourselves and can only be prevented by cultivating sincere affection for others.
Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring CompassionBehavioural
Completed at Week 7. Participants are invited to deepen their reflection on the reasons for gratitude, empathy, and affection for others, and see how they lead to feelings of compassion, or the wish for others to be free from suffering.
Cognitive Based Compassion Training Session: Realizing Active CompassionBehavioural
Completed at Week 8. The strategies used until this point will be reviewed in order to move from the wish for others to be free of suffering, toward the sense that we want to and must take steps to relieve their suffering.
Meditation SessionBehavioural
20 minute session completed weekly after the Cognitive Training Session
| Study group | Role | What they receive |
|---|---|---|
| Caregiver of Child With Autism Spectrum Disorder | Experimental | Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation. Receives: Behavioral: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind; Behavioral: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience; Behavioral: Cognitive Based Compassion Training Session: Self-compassion; Behavioral: Cognitive Based Compassion Training Session: Cultivating Equanimity; Behavioral: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others; Behavioral: Cognitive Based Compassion Training Session: Developing Affection and Empathy; Behavioral: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion; Behavioral: Cognitive Based Compassion Training Session: Realizing Active Compassion; Behavioral: Meditation Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberrant Behavior Checklist (ABC) Score
Designed to assess behavior problems in children with developmental difficulties and it consists of 58 items grouped in five subscales (irritability, social withdrawal, stereotypic behaviors, hyperactivity, and inappropriate behavior). The irritability subscale comprises of 15 statements that have been used as an index of Autism Spectrum Disorder-specific disability.
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Secondary outcomes (7)
Change in Parenting Stress Index/Short Form (PSI/SF) Score
A 36-item measure designed to evaluate the magnitude of stress in caregiver-child relationships. All items have a 5-point response scale (roughly, Strongly Agree, Agree, Not Sure, Disagree, Strongly Disagree) and yield a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Perceived Stress Scale (PSS) Score
An instrument to measure non-specific appraised stress which correlates with biological markers like cortisol, immune markers, and depression. It consists of 14 items rated on a 5 point scale (from never to very often) that refer to feelings and thoughts over the past month.
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Acceptance and Action Questionnaire (AAQ) Score
A list of 10 statements rated from 1 (never true) to 7 (always true) measures psychological acceptance or assent to the reality of a situation (e.g., "it's okay if I remember something unpleasant").
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Interpersonal Reactivity Index (IRI) Score
A self-report questionnaire of 28 items answered on a 5-point scale ranging from "Does not describe me well" to "Describes me very well". It is considered a measure of empathy as a multidimensional construct that can be factored in four first-order factors, corresponding to the four subscales of the IRI: Perspective Taking, Fantasy (or tendency to transpose into the feelings and actions of fictitious characters in books and movies), Empathic Concern (interpersonal sympathy and concern), and Personal Distress (interpersonal distress).
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Mindful Attention Awareness Scale (MAAS) Score
A questionnaire to measure attentiveness and mindfulness as a trait and it includes 15 items with answers on a 6-point scale (from "almost always" to "almost never").
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Score
A self-report assessment of executive function behaviors for adults aged 18-90. It contains 86 items in two validity scales and eight clinical scales that form two indexes: a) Behavioral Regulation (four scales: inhibit, shift, emotional control, and self-monitor) and b) Metacognition (five scales: initiate, working memory, plan/organize, organization of materials, and monitor), as well as a Global Executive Composite score.
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Parenting Sense of Competence Scale Score
A 16 item questionnaire (on a 6 point scale ranging from strongly agree to strongly disagree), it includes a section on Satisfaction, with nine questions that examine the parents' anxiety, motivation and frustration, and an Efficacy scale, with 7 questions covering parents' sense of competence, capability levels, and problem-solving abilities in their parenting role.
Measured: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJun 2014
- Primary completion11 Feb 2016
- Study completion11 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Fernandez-Carriba, Emory University
- Investigators
- Samuel Fernandez-Carriba, PhD, Principal investigator, Emory University Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574559
- Sponsor's protocol ID
- IRB00074454
- Status last verified
- Jan 2020
- First submitted
- 9 Oct 2015
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitively Based Compassion Training for Parents of Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02574559
- Acronym / sponsor ID
- IRB00074454
- Conditions
- Stress
- Keywords
- Caregiver, Stress, Depression, Autism Spectrum Disorder, Compassion Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 11 Feb 2016 (actual)
- First posted
- 14 Oct 2015 (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.
The purpose of this study is to determine if caregivers of children with a developmental delay experience a decrease in stress by participating in a meditation/cognitive training protocol.
Detailed description
A pilot-test, eight week, Cognitive Based Compassion Training (CBCT) program for caregivers of children with developmental delays that is comprised of eight two-hour weekly long sessions with a certified instructor followed by a twenty minute long meditation session. Sessions will focus on developing attention and stability of mind through focused attention training; cultivating insight into the nature of mental experience; cultivating self-compassion; developing equanimity; developing appreciation and gratitude; developing affection and empathy; realizing aspirational compassion; and realizing active compassion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver of Child With Autism Spectrum Disorder | Experimental | Behavioral: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind, Behavioral: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience, Behavioral: Cognitive Based Compassion Training Session: Self-compassion, Behavioral: Cognitive Based Compassion Training Session: Cultivating Equanimity, Behavioral: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others, Behavioral: Cognitive Based Compassion Training Session: Developing Affection and Empathy, Behavioral: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion, Behavioral: Cognitive Based Compassion Training Session: Realizing Active Compassion, Behavioral: Meditation SessionCaregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Caregiver of child(ren) with developmental delay (including parents, grandparents, other extended family, family friends, and providers)
- Spend significant amount of time (more than 10 hours/week) with children with special needs.
Key exclusion criteria (2 listed)
- Started to use any psychotropic medication within one year.
- Had any changes in any psychotropic medication doses taken within one year.
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 |
|---|---|---|
| Cognitive Based Compassion Training Session: Developing Attention and Stability of MindCompleted at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental ExperienceCompleted at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Self-compassionCompleted at Week 3: Techniques to analyze mental processes are introduced. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Cultivating EquanimityCompleted at Week 4. Further analysis of mental processes. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for OthersCompleted at Week 5. A reflection of all the things that bring us well-being are provided by or dependent upon other beings is encouraged. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Developing Affection and EmpathyCompleted at Week 6. The following concepts are presented and carefully considered: (1) cooperation and solidarity is essential for our survival and flourishing, as we are all extremely vulnerable and need each other; (2) hate and selfishness only cause suffering to others and ourselves and can only be prevented by cultivating sincere affection for others. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring CompassionCompleted at Week 7. Participants are invited to deepen their reflection on the reasons for gratitude, empathy, and affection for others, and see how they lead to feelings of compassion, or the wish for others to be free from suffering. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Cognitive Based Compassion Training Session: Realizing Active CompassionCompleted at Week 8. The strategies used until this point will be reviewed in order to move from the wish for others to be free of suffering, toward the sense that we want to and must take steps to relieve their suffering. | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
| Meditation Session20 minute session completed weekly after the Cognitive Training Session | Behavioural | Caregiver of Child With Autism Spectrum Disorder |
Primary outcome
Change in Aberrant Behavior Checklist (ABC) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Designed to assess behavior problems in children with developmental difficulties and it consists of 58 items grouped in five subscales (irritability, social withdrawal, stereotypic behaviors, hyperactivity, and inappropriate behavior). The irritability subscale comprises of 15 statements that have been used as an index of Autism Spectrum Disorder-specific disability.
7 secondary outcomes
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Perceived Stress Scale (PSS) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Acceptance and Action Questionnaire (AAQ) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Interpersonal Reactivity Index (IRI) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Mindful Attention Awareness Scale (MAAS) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Parenting Sense of Competence Scale Score
Time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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 31 Jan 2020.
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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.
Samuel Fernandez-Carriba, PhD principal investigator
Emory University Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind, Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience and Cognitive Based Compassion Training Session: Self-compassion in people with Stress, run by Emory University at 2 sites 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 2 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 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Aberrant Behavior Checklist (ABC) Score (time frame: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)). 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 31 Jan 2020.