CBCT for Parents of Children With Autism
keskiviikko 29. tammikuuta 2020 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
- Käyttäytyminen: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
- Käyttäytyminen: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
- Käyttäytyminen: Cognitive Based Compassion Training Session: Self-compassion
- Käyttäytyminen: Cognitive Based Compassion Training Session: Cultivating Equanimity
- Käyttäytyminen: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
- Käyttäytyminen: Cognitive Based Compassion Training Session: Developing Affection and Empathy
- Käyttäytyminen: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
- Käyttäytyminen: Cognitive Based Compassion Training Session: Realizing Active Compassion
- Käyttäytyminen: Meditation Session
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
29
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, Yhdysvallat, 30322
- Emory University
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
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
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Score
Aikaikkuna: 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.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Aikaikkuna: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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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)
|
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Change in Perceived Stress Scale (PSS) Score
Aikaikkuna: 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.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Acceptance and Action Questionnaire (AAQ) Score
Aikaikkuna: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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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").
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Interpersonal Reactivity Index (IRI) Score
Aikaikkuna: 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).
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Mindful Attention Awareness Scale (MAAS) Score
Aikaikkuna: 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)
|
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Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Score
Aikaikkuna: 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)
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Change in Parenting Sense of Competence Scale Score
Aikaikkuna: 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.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. kesäkuuta 2014
Ensisijainen valmistuminen (Todellinen)
Torstai 11. helmikuuta 2016
Opintojen valmistuminen (Todellinen)
Torstai 11. helmikuuta 2016
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 9. lokakuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 9. lokakuuta 2015
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 14. lokakuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 31. tammikuuta 2020
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 29. tammikuuta 2020
Viimeksi vahvistettu
Keskiviikko 1. tammikuuta 2020
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB00074454
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .