Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children with Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 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 Therapy (ACT) based group treatment (Navigator ACT) for treatment of stress and distress in parents of children with disabilities, and to investigate the concept of parental psychological flexibility. 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 (if treatment proves feasible), a randomised controlled trial (RCT) is conducted. In the RCT, approximately n=100 parents of children with disabilties were expected to be included, divided into experiment- and control groups. The recruitment takes places in several regions in Sweden. In addition, a psychometric evaluation of the main outcome instrument used in these studies, is going to be conducted. The Parental Acceptance and Action Questionnaire (PAAQ). In an additional study (expected n= ca 600), will focus on factors that explain treatment outcome and attrition.
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, in Sweden. The treatment consists of 5 sessions (each 3.5 hours), and has a main aim of increasing psychological flexibility of stressed and distressed parents raising a child with disability. The studies included in this project examine the feasibility and effectiveness 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 in the disability services context? Is it effective in (a) improving parental psychological flexibility (b) increasing mindfulness (c) reducing symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported difficulties ior increasing prosocial behaviors(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 at least 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 Treatment-As-Usual (TAU) control group approximately six months after. The parents in the TAU group fill the effectiveness-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.
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
- 否
入选标准
- •a parent to a child 0-18 years with diagnosed 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
研究组 & 干预措施
Acceptance- and Commitment therapy group
Experiment group that receives the treatment direct after the baseline measurement.
干预措施: Acceptance- and Commitment therapy group for parents to children with disabilities (Behavioral)
Treatment as usual
Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later.
干预措施: Treatment as usual. (Behavioral)
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
Tatja Hirvikoski
Associate Professor
Karolinska Institutet