CBCT for Parents of Children With Autism
Primary Purpose
Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Cognitive Based Compassion Training Session: Developing Affection and Empathy
Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
Cognitive Based Compassion Training Session: Realizing Active Compassion
Meditation Session
Sponsored by
About this trial
This is an interventional supportive care trial for Stress focused on measuring Caregiver, Stress, Depression, Autism Spectrum Disorder, Compassion Meditation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Started to use any psychotropic medication within one year.
- Had any changes in any psychotropic medication doses taken within one year.
Sites / Locations
- Children's Healthcare of Atlanta
- Emory University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caregiver of Child With Autism Spectrum Disorder
Arm Description
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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").
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).
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").
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02574559
Brief Title
CBCT for Parents of Children With Autism
Official Title
Cognitively Based Compassion Training for Parents of Children With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 11, 2016 (Actual)
Study Completion Date
February 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
Caregiver, Stress, Depression, Autism Spectrum Disorder, Compassion Meditation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caregiver of Child With Autism Spectrum Disorder
Arm Type
Experimental
Arm Description
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
Intervention Description
Completed at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
Intervention Description
Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Self-compassion
Intervention Description
Completed at Week 3: Techniques to analyze mental processes are introduced.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Cultivating Equanimity
Intervention Description
Completed at Week 4. Further analysis of mental processes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Developing Affection and Empathy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Based Compassion Training Session: Realizing Active Compassion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation Session
Intervention Description
20 minute session completed weekly after the Cognitive Training Session
Primary Outcome Measure Information:
Title
Change in Aberrant Behavior Checklist (ABC) Score
Description
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.
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Secondary Outcome Measure Information:
Title
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Description
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.
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Title
Change in Perceived Stress Scale (PSS) Score
Description
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.
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Title
Change in Acceptance and Action Questionnaire (AAQ) Score
Description
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").
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Title
Change in Interpersonal Reactivity Index (IRI) Score
Description
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).
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Title
Change in Mindful Attention Awareness Scale (MAAS) Score
Description
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").
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Title
Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Score
Description
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.
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Title
Change in Parenting Sense of Competence Scale Score
Description
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.
Time Frame
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Started to use any psychotropic medication within one year.
Had any changes in any psychotropic medication doses taken within one year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Fernandez-Carriba, PhD
Organizational Affiliation
Emory University Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
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CBCT for Parents of Children With Autism
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