NCT02574559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2016

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

October 9, 2015

Last Update Submit

January 29, 2020

Conditions

Keywords

CaregiverStressDepressionAutism Spectrum DisorderCompassion Meditation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

  • Change in Perceived Stress Scale (PSS) Score

    Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

  • Change in Acceptance and Action Questionnaire (AAQ) Score

    Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

  • Change in Interpersonal Reactivity Index (IRI) Score

    Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

  • Change in Mindful Attention Awareness Scale (MAAS) Score

    Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

  • +2 more secondary outcomes

Study Arms (1)

Caregiver of Child With Autism Spectrum Disorder

EXPERIMENTAL

Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.

Behavioral: Cognitive Based Compassion Training Session: Developing Attention and Stability of MindBehavioral: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental ExperienceBehavioral: Cognitive Based Compassion Training Session: Self-compassionBehavioral: Cognitive Based Compassion Training Session: Cultivating EquanimityBehavioral: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for OthersBehavioral: Cognitive Based Compassion Training Session: Developing Affection and EmpathyBehavioral: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring CompassionBehavioral: Cognitive Based Compassion Training Session: Realizing Active CompassionBehavioral: Meditation Session

Interventions

Completed at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.

Caregiver of Child With Autism Spectrum Disorder

Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.

Caregiver of Child With Autism Spectrum Disorder

Completed at Week 3: Techniques to analyze mental processes are introduced.

Caregiver of Child With Autism Spectrum Disorder

Completed at Week 4. Further analysis of mental processes.

Caregiver of Child With Autism Spectrum Disorder

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.

Caregiver of Child With Autism Spectrum Disorder

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.

Caregiver of Child With Autism Spectrum Disorder

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.

Caregiver of Child With Autism Spectrum Disorder

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.

Caregiver of Child With Autism Spectrum Disorder

20 minute session completed weekly after the Cognitive Training Session

Caregiver of Child With Autism Spectrum Disorder

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Started to use any psychotropic medication within one year.
  • Had any changes in any psychotropic medication doses taken within one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

DepressionAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Samuel Fernandez-Carriba, PhD

    Emory University Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 14, 2015

Study Start

June 1, 2014

Primary Completion

February 11, 2016

Study Completion

February 11, 2016

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations