CBCT for Parents of Children With Autism
29. januar 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Self-compassion
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Cultivating Equanimity
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Developing Affection and Empathy
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
- Adfærdsmæssigt: Cognitive Based Compassion Training Session: Realizing Active Compassion
- Adfærdsmæssigt: Meditation Session
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
|
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.
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Score
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Tidsramme: 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.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Perceived Stress Scale (PSS) Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2014
Primær færdiggørelse (Faktiske)
11. februar 2016
Studieafslutning (Faktiske)
11. februar 2016
Datoer for studieregistrering
Først indsendt
9. oktober 2015
Først indsendt, der opfyldte QC-kriterier
9. oktober 2015
Først opslået (Skøn)
14. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00074454
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .