CBCT for Parents of Children With Autism

January 29, 2020 updated by: Samuel Fernandez-Carriba, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
Behavioral: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
Completed at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
Behavioral: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
Behavioral: Cognitive Based Compassion Training Session: Self-compassion
Completed at Week 3: Techniques to analyze mental processes are introduced.
Behavioral: Cognitive Based Compassion Training Session: Cultivating Equanimity
Completed at Week 4. Further analysis of mental processes.
Behavioral: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
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.
Behavioral: Cognitive Based Compassion Training Session: Developing Affection and Empathy
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.
Behavioral: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
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.
Behavioral: Cognitive Based Compassion Training Session: Realizing Active Compassion
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.
Behavioral: Meditation Session
20 minute session completed weekly after the Cognitive Training Session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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").
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)
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).
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)
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").
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)
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.
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)
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.
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 11, 2016

Study Completion (Actual)

February 11, 2016

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00074454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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