CBCT for Parents of Children With Autism
29 januari 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
- Gedragsmatig: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
- Gedragsmatig: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
- Gedragsmatig: Cognitive Based Compassion Training Session: Self-compassion
- Gedragsmatig: Cognitive Based Compassion Training Session: Cultivating Equanimity
- Gedragsmatig: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
- Gedragsmatig: Cognitive Based Compassion Training Session: Developing Affection and Empathy
- Gedragsmatig: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
- Gedragsmatig: Cognitive Based Compassion Training Session: Realizing Active Compassion
- Gedragsmatig: Meditation Session
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
29
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
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Completed at Week 1.
Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
Completed at Week 3: Techniques to analyze mental processes are introduced.
Completed at Week 4. Further analysis of mental processes.
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.
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.
Gedragsmatig: 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.
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.
20 minute session completed weekly after the Cognitive Training Session
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Score
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Parenting Sense of Competence Scale Score
Tijdsspanne: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2014
Primaire voltooiing (Werkelijk)
11 februari 2016
Studie voltooiing (Werkelijk)
11 februari 2016
Studieregistratiedata
Eerst ingediend
9 oktober 2015
Eerst ingediend dat voldeed aan de QC-criteria
9 oktober 2015
Eerst geplaatst (Schatting)
14 oktober 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 januari 2020
Laatste update ingediend die voldeed aan QC-criteria
29 januari 2020
Laatst geverifieerd
1 januari 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00074454
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