Clinical trial NCT03830476: Navigator ACT Group Intervention for Parents of Children with Disabilities
Official title: Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children with Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Stress
Disability, Developmental
Behavior, Child
Acceptance and Action Processes
Parent-Child Relations
Experiential Avoidance
Depression, Anxiety
Keywords: Acceptance- and Commitment Therapy, ACT, parenting stress, parenting a child with disability, depression, anxiety, disabilities
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2019-02-05
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility study and Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has approved the studIes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 1. Change (increase) in parental psychological flexibility and experiential acceptance
timeFrame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Secondary outcomes:
measure: 2. Change (increase) in mindfulness skills
timeFrame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
measure: 3. Change (decrease) in depression and anxiety
timeFrame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
measure: 4. Change (decrease) in parental stress.
timeFrame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
measure: 5. Change (decrease) in child's difficulties and the impact of these difficulties on the child's family.
timeFrame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Other outcomes:
measure: Treatment Credibility Scale (TCS)
timeFrame: Measured at baseline,and immediately after the intervention.
measure: Session Evaluation Form (SEF)
timeFrame: Up to 3 months
measure: Patient Evaluation Form (PEF)
timeFrame: Up to 3 months
Locations:
city: Knivsta
country: Sweden
facility: Tiina Maria Holmberg Bergman
Study officials:
References: