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临床试验/NCT05944289
NCT05944289已完成不适用

Acceptance and Commitment Therapy for Stress Reduction in Caregivers of Children With Autism Spectrum Disorder: A Pilot Study

Fielding Graduate University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Brief Symptom Inventory-18 (BSI-18)

研究概览

简要总结

Parents/Caregivers of children with autism need psychological flexibility and self-efficacy for the ACT program to be effective.

This study will compare intervention differences between groups. Repeated measures will be given three times (pre-intervention, post-intervention, and follow-up) to an ACT intervention group and a support group (control). The purpose of the present study is to compare the effects of a brief ACT-based workshop for parents of children with autism with a concurrent parent support control group using a variety of self-report measures addressing psychological flexibility, depression, thought suppression, cognitive fusion, positive aspects of caregiving, stress, self-compassion, and valued living.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Individuals will be eligible for entry if (1) they are the biological or adoptive parent (and primary caregiver) of a child with a diagnosis of an autism spectrum disorder, (2) the child is 2-17 years of age inclusive, (3) speak English, and (4) they plan to live in the area for at least six months and (5) present proof of vaccination and (6) agree to masking and social distancing during the in-person workshop.

排除标准

  • •Individuals will be excluded from the study if (1) they are involved in a concurrent clinical trial of psychosocial interventions for parents/caregivers or (2) they (or their child/spouse) indicate during telephone screening or on the demographics questionnaire active major medical issues such as cancer, organ transplant, or severe mental health disorders that prevent active participation.

研究组 & 干预措施

ACT

Experimental

ACT Intervention Group

干预措施: Acceptance and Commitment Therapy (Behavioral)

Support

Other

Control Group - Caregiver support group

干预措施: Caregiver Support Group (Behavioral)

结局指标

主要结局

Brief Symptom Inventory-18 (BSI-18)

时间窗: Follow-up- completed within 1 month of intervention completion

18-item self-administered measure that provides information on participants' overall psychological distress and Global Severity Index, as well as scales of somatization, depression, and anxiety

Perceived Stress Scale - 10 Items (PSS-10)

时间窗: Follow-up- completed within 1 month of intervention completion

10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded

Positive Aspects of Caregiving (PAC)

时间窗: Follow-up- completed within 1 month of intervention completion

nine-item pencil-and-paper instrument that assesses caregivers' subjectively perceived gains from desirable aspects of or positive affective returns from providing care for their loved one

Parental Stress Index-Short Form (PSI-SF)

时间窗: Follow-up- completed within 1 month of intervention completion

36-item self-report instrument

Self-Compassion Scale - Short Form (SCS-SF)

时间窗: Follow-up- completed within 1 month of intervention completion

12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification

Brief Symptom Inventory-18 (BSI-18)

时间窗: Baseline - prior to intervention particpation

18-item self-administered measure that provides information on participants' overall psychological distress and Global Severity Index, as well as scales of somatization, depression, and anxiety

Brief Symptom Inventory-18 (BSI-18)

时间窗: Post - within two weeks of intervention completion

18-item self-administered measure that provides information on participants' overall psychological distress and Global Severity Index, as well as scales of somatization, depression, and anxiety

Perceived Stress Scale - 10 Items (PSS-10)

时间窗: Baseline - prior to intervention particpation

10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded

Perceived Stress Scale - 10 Items (PSS-10)

时间窗: Post - within two weeks of intervention completion

10-item questionnaire used to measure the degree to which life has been experienced as unpredictable, uncontrollable, and overloaded

Positive Aspects of Caregiving (PAC)

时间窗: Baseline - prior to intervention particpation

nine-item pencil-and-paper instrument that assesses caregivers' subjectively perceived gains from desirable aspects of or positive affective returns from providing care for their loved one

Positive Aspects of Caregiving (PAC)

时间窗: Post - within two weeks of intervention completion

nine-item pencil-and-paper instrument that assesses caregivers' subjectively perceived gains from desirable aspects of or positive affective returns from providing care for their loved one

Parental Stress Index-Short Form (PSI-SF)

时间窗: Baseline - prior to intervention particpation

36-item self-report instrument

Parental Stress Index-Short Form (PSI-SF)

时间窗: Post - within two weeks of intervention completion

36-item self-report instrument

Self-Compassion Scale - Short Form (SCS-SF)

时间窗: Baseline - prior to intervention particpation

12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification

Self-Compassion Scale - Short Form (SCS-SF)

时间窗: Post - within two weeks of intervention completion

12-item self-report measure of self-compassion, such as self-kindness, self-judgment, common humanity, isolation, mindfulness, and overidentification

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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