- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03830476
Navigator ACT Group Intervention for Parents of Children With Disabilities (NavigatorACT)
Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children With Disabilities
Study Overview
Status
Conditions
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. 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.
The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has approved the studIes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Knivsta, Sweden, 74131
- Tiina Maria Holmberg Bergman
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- deep depression with suicidality
- psychosis or manic episodes
- severe post-traumatic stress disorder (PTSD)
- homelessness or other extreme life situation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acceptance- and Commitment therapy group
Experiment group that receives the treatment direct after the baseline measurement.
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ACT groups adjusted for parents of children with (any kind of) disabilities.
Other Names:
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Active Comparator: Treatment as usual
Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later.
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Treatment as usual within outpatient disability services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. Change (increase) in parental psychological flexibility and experiential acceptance
Time Frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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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.
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[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2. Change (increase) in mindfulness skills
Time Frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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The Mindfulness Awareness Attention Scale (MAAS), a 15-item scale (scored 1-6) assessing dispositional mindfulness in regards to cognitive, emotional, physical, interpersonal and general domains.
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[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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3. Change (decrease) in depression and anxiety
Time Frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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Hospital Anxiety and Depression Scale (HADS).
Has 14 items scored 0 ("Often") - 3 ("Seldom"), subsequently summarized for an overall score; high scores indicate higher levels of depression or anxiety.
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[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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4. Change (decrease) in parental stress.
Time Frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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The Parental Stress Scale (PSS) is a18-item tool for measurement of parenting stress, scored 1-5 on a 5-point Likert scale.
The initial factor has suggested four-factor structure for the PSS consisting of parental 1) rewards, 2) stressors, 3) lack of control and 4) satisfaction in parenting.
High scores indicate higher levels of stress in parenting context.
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[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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5. Change (decrease) in child's difficulties and the impact of these difficulties on the child's family.
Time Frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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The Strengths and Difficulties Questionnaire (P4-17 SDQ), a caregiver administered, 25-item extended version of SDQ used for behavior screening of children and adolescents in ages 4-17 years.
The SDQ P4-17 covers common areas of emotional and behavioral difficulties and strengths as well as includes a caregiver reported impact- and burden assessment.
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[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Credibility Scale (TCS)
Time Frame: Measured at baseline,and immediately after the intervention.
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As a measure of feasibility, TCS is used to measure the expectation of improvement and treatment credibility.
The TCS is a visual analogue scale rated from "Low credibility"/ "Not at all" (0) to "High credibility"/"Very much" (10) and the score calculated is a mean of all items.
The TCS was administered after providing thorough information and presentation of the treatment content at baseline and after completion of the treatment.
The item wording after adjustment to the current study were: (1) How logical does Navigator ACT treatment seem to you? (2) How confident are you that this treatment will reduce your distress?
(3) Would you recommend Navigator ACT to a friend experiencing the same type of distress?
(4) How successful do you feel this type of intervention is in improving your psychological health?
5) At this very moment, to what degree the intervention has improved your psychological health?
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Measured at baseline,and immediately after the intervention.
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Session Evaluation Form (SEF)
Time Frame: Up to 3 months
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Measures treatment satisfaction regarding each treatment session
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Up to 3 months
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Patient Evaluation Form (PEF)
Time Frame: Up to 3 months
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Measures overall treatment satisfaction
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Up to 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Navigator ACT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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