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临床试验/NCT03830476
NCT03830476已完成不适用

Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children With Disabilities

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2016年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
2
主要终点
1. Change (increase) in parental psychological flexibility and experiential acceptance

研究概览

简要总结

The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic, manualized acceptance and commitment (ACT) therapy group treatment (Navigator ACT) in treatment of stress and distress in parents of children with disabilities, and to investigate the concepts of experiential avoidance and psychological flexibility in the context of parenting. The first phase includes a feasibility study (n=94) of the Navigator ACT for parents of children (0-17 years) with disabilties who participate in the Navigator ACT group treatment after being screened for symptoms of stress, depression and anxiety associated with the challenges of parenting. In the second phase a randomised controlled trial (RCT) is conducted. In the RCT, we expect to include approximately n=100 parents of children with disabilties divided into experiment- and control groups. The recruitment takes places in several regions in Sweden. In addition, we are going to complete a psychometric evaluation of the main outcome instrument used in these studies, The Parental Acceptance and Action Questionnaire (PAAQ). In an additional study (expected n= ca 600), we will predict factors that explain treatment outcome and attrition as well as investigate process variables in a mediation model,

详细描述

Navigator ACT group treatment is a novel, manual-based, transdiagnostic group treatment developed in Habilitation and Health, the disability services in the region Stockholm. The treatment consists of 5 sessions (each 3.5 hours), and is developed to address stress and distress in parents raising a child with disability. The aims of the several studies included in this project is to examine the feasibility and effectiveness/efficacy of the manual-based Navigator ACT group treatment in the Swedish habilitation services context. The guestions we ask are; Is the Navigator ACT a feasible treatment? Is it effective in (a) improving parental psychological flexibility/experiential acceptance (b) increasing mindfulness (c) reducing symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported difficulties (e.g., behavioral problems) of children with disability.

FAS 1: The feasibility study is conducted in 7 disability service clinics in Stockholm and Uppsala, Sweden.The feasibility of Navigator ACT in the disability services context is measured by attendance, that is: parents participating in at least 4 out of 5 sessions are considered as completers. The parent and treatment provider satisfaction is measured by session- and course evaluations. Both parents and group leaders treatment credibility and expectancy is measured as well. Five self-rating questionnaires are used to measure efficacy: The Mindfulness Awareness Attention Scale (MAAS), Parental Acceptance and Action Questionnaire (PAAQ) Parental Stress Scale (PSS) Hospital Anxiety and depression scale (HADS), The Strengths and Difficulties Questionnaire (SDQ). Self-rating questionnaires are administered to parents at the baseline (0-2 weeks before the treatment start, T1), at the end of the treatment (0-2 weeks after, T2) and at the follow-up (3-4 months after the end of the treatment, T3). The data will be analyzed from baseline T1 to T2 (post treatment) as well as from T1 (baseline) to T3 (follow-up) with separate series of repeated measures ANOVA between-group.

FAS 2: Psychometric evaluation of the Parental Acceptance and Action Questionnaire (PAAQ).

FAS 2. The pragmatic multicenter RCT will be conducted in four regions of Sweden. Parents participating in the study have their children (0-17 years) currently enrolled in the disability services (experiment group n=42, control group n=42, totaling at least 84 parents, with the power calculation for medium large effect of 90% ES=0.50). To balance for attrition approximately 100 parents will be included in the study. The participants will be block randomized in several blocks. The experiment group will be receiving Navigator ACT treatment directly after the randomizing procedure, the control group approximately six months after. The parents in the control group fill the efficacy-related self-rating forms at the same measuring points as the parents in the experiment group as well during their own group process. The differences between the experiment and control groups will be analyzed by mixed-model linear regression.

FAS4: The aim of this study is reveal which parents get the most benefit of the Navigator ACT treatment, and what factors predict treatment competition vs. attrition. An additional aim is to investigate what treatment specific ACT processes mediate the treatment outcomes.

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
Single (Care Provider)

盲法说明

Masking at baseline of both participant and care-provider.

入排标准

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

入选标准

  • a parent to a child 0-17 years with disability
  • mild to severe symptoms of parental stress, depression or anxiety
  • a possibility to participate in all group sessions
  • an ability to function in a group
  • a knowledge of the Swedish language

排除标准

  • deep depression with suicidality
  • psychosis or manic episodes
  • severe post-traumatic stress disorder (PTSD)
  • homelessness or other extreme life situation

结局指标

主要结局

1. Change (increase) in parental psychological flexibility and experiential acceptance

时间窗: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]

Parental Acceptance and Action Questionnaire (PAAQ), a scale that targets psychological flexibility and experiential acceptance in the parenting context, i.e. measures to which extent parents' accept inner experiences related to parenting and the readiness to take appropriate/needed action in parenting (commitment to values-based actions). Originally 19-item scale.

次要结局

  • 5. Change (decrease) in child's difficulties and the impact of these difficulties on the child's family.([Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up])
  • 2. Change (increase) in mindfulness skills([Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up])
  • 4. Change (decrease) in parental stress.([Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up])
  • 3. Change (decrease) in depression and anxiety([Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatja Hirvikoski

Associate Professor

Karolinska Institutet

研究点 (2)

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