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CBCT for Parents of Children With Autism

29. Januar 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

29

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Children's Healthcare of Atlanta
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Emory University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
Verhalten: 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.
Verhalten: 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.
Verhalten: Cognitive Based Compassion Training Session: Self-compassion
Completed at Week 3: Techniques to analyze mental processes are introduced.
Verhalten: Cognitive Based Compassion Training Session: Cultivating Equanimity
Completed at Week 4. Further analysis of mental processes.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: Meditation Session
20 minute session completed weekly after the Cognitive Training Session

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Aberrant Behavior Checklist (ABC) Score
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Emory University

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2014

Primärer Abschluss (Tatsächlich)

11. Februar 2016

Studienabschluss (Tatsächlich)

11. Februar 2016

Studienanmeldedaten

Zuerst eingereicht

9. Oktober 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Oktober 2015

Zuerst gepostet (Schätzen)

14. Oktober 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00074454

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