MedPath

CBCT for Parents of Children With Autism

Not Applicable
Completed
Conditions
Stress
Interventions
Behavioral: Meditation Session
Registration Number
NCT02574559
Lead Sponsor
Emory University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
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.
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Exclusion Criteria
  • Started to use any psychotropic medication within one year.
  • Had any changes in any psychotropic medication doses taken within one year.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Caregiver of Child With Autism Spectrum DisorderMeditation SessionCaregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
Primary Outcome Measures
NameTimeMethod
Change in Aberrant Behavior Checklist (ABC) ScoreBaseline, 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.

Secondary Outcome Measures
NameTimeMethod
Change in Perceived Stress Scale (PSS) ScoreBaseline, 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.

Change in Acceptance and Action Questionnaire (AAQ) ScoreBaseline, 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").

Change in Interpersonal Reactivity Index (IRI) ScoreBaseline, 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).

Change in Parenting Sense of Competence Scale ScoreBaseline, 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.

Change in Parenting Stress Index/Short Form (PSI/SF) ScoreBaseline, 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.

Change in Mindful Attention Awareness Scale (MAAS) ScoreBaseline, 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").

Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) ScoreBaseline, 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.

Trial Locations

Locations (2)

Emory University

🇺🇸

Atlanta, Georgia, United States

Children's Healthcare of Atlanta

🇺🇸

Atlanta, Georgia, United States

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