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CBCT for Parents of Children With Autism

29. ledna 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

29

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30322
        • Children's Healthcare of Atlanta
      • Atlanta, Georgia, Spojené státy, 30322
        • Emory University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
Behaviorální: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
Completed at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
Behaviorální: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
Behaviorální: Cognitive Based Compassion Training Session: Self-compassion
Completed at Week 3: Techniques to analyze mental processes are introduced.
Behaviorální: Cognitive Based Compassion Training Session: Cultivating Equanimity
Completed at Week 4. Further analysis of mental processes.
Behaviorální: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
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.
Behaviorální: Cognitive Based Compassion Training Session: Developing Affection and Empathy
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.
Behaviorální: 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.
Behaviorální: Cognitive Based Compassion Training Session: Realizing Active Compassion
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.
Behaviorální: Meditation Session
20 minute session completed weekly after the Cognitive Training Session

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Aberrant Behavior Checklist (ABC) Score
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
Change in Parenting Sense of Competence Scale Score
Časové okno: 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.
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Emory University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2014

Primární dokončení (Aktuální)

11. února 2016

Dokončení studie (Aktuální)

11. února 2016

Termíny zápisu do studia

První předloženo

9. října 2015

První předloženo, které splnilo kritéria kontroly kvality

9. října 2015

První zveřejněno (Odhad)

14. října 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

31. ledna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. ledna 2020

Naposledy ověřeno

1. ledna 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB00074454

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