- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250012
Web-based ACT to Support Parents With Children With Chronic and Developmental Conditions (Uupu)
Effectiveness of a Web-based Acceptance and Commitment Therapy for Wellbeing of Parents With Children With Chronic and Developmental Conditions: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Numerous studies have shown that parents of children with long-term and intellectual disabilities suffer more often from symptoms such as stress, anxiety and depression symptoms, feelings of uncertainty and fear, and loss of quality of life. In Finland, there are approximately 17.000 families where the illness or disability of a child under the age of 16 causes an extra daily burden for parents. Especially mothers of long-term or disabled children are vulnerable and have an increased risk of psychological symptoms. Parents of children with a chronic disease or functional disability also have an increased risk of stress-related distress and reduced quality of life. Prolonged psychological symptoms associated with caring for a child with a long-term illness can expose to chronic exhaustion and burnout, which can have serious health effects. The birth of a disabled child and the illness of a child with long-term illness also increases the risk of divorce in the family. Considering the hardship and challenges of this population group, special attention should be paid to their rehabilitation and access to services.
In Finland, for example, the Finnish Social Insurance Institution offers adaptation training and family-oriented rehabilitation courses for family caregivers. However, this form of support has limited availability and, on the other hand, is of relatively short duration. Several studies indicate, however, that the parents' mental health also affects the health and development of the child, and especially the long-term stress experienced by the parent can be harmful to children. The challenge is to motivate parents to take care of themselves and thus to have a better capacity to care for their children in need of special support. The majority of parents have a full-time employment, which also poses challenges for the forms of support. Therefore, the support of this parent group should focus on treatments that are easily available for them.
Web-based treatments offer one solution for delivering evidence-based psychological treatments for this distressed parents, who may often have challenges in finding time to access face-to-face services. Web-based interventions have been developed and tested for a wide range of health problems, including parental wellbeing. Advantages of web-based interventions are that they are not bound to time and place. They are available when most needed and enable integration of the intervention in everyday life.
Acceptance and commitment therapy (ACT) represents the third-wave of Cognitive Behavioral Therapies and incorporates mindfulness, experiential acceptance, and valued action (e.g., engagement in meaningful, values-driven activities) to promote psychological flexibility. Several studies and meta-analyses have shown that acceptance and commitment therapy has a positive effect on a variety of psychological symptoms. Promising results from web-based ACT interventions have been obtained for example for the treatment of stress, anxiety, and depression. ACT and other mindfulness-based treatments have been shown to improve psychological adjustment and to decrease stress in parents of children with developmental disabilities including autism and acquired brain injury.
The aim of the current study is to investigate the effectiveness of a web-based ACT intervention on wellbeing of parents with exhaustion and burnout symptoms, and whose children have chronic conditions and/or developmental disabilities. Effects will be investigated at before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. The research questions are the following:
- Does the guided acceptance and commitment-based online intervention decrease the burnout and depression symptoms of parents of children with long-term illnesses and improve their quality of life, psychological flexibility, mindfulness skills, and cognitive strategies?
- Which psychological processes (i.e., psychological flexibility, mindfulness skills, cognitive strategies) act as mediators of change?
- Do the changes in the well-being of the parents improve the quality of life of the child?
- How do parents experience online intervention and what kind of parent group especially will benefit from online support?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jyväskylä, Finland, 40014
- Department of Psychology, UNiversity of Jyvaskyla
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The parent:
- has a child (aged 0-18 years) with a long-term illness or developmental disorder or disability,
- has symptoms of burnout based on the Shirom-Melamed Burnout questionnaire (SMBQ), i.e. at least 2.75 points.
- has access to computer and internet.
Exclusion Criteria:
The parent:
- has an inadequate knowledge of the Finnish language (unable to fill in questionnaires or follow the program);
- has parallel regular psychological treatment or therapy
- has a severe mental disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet-based ACT intervention
Group "Internet-based ACT intervention" will receive a 10-week internet-based acceptance and commitment therapy intervention with three remote meetings with a psychologist
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The Internet-based ACT intervention included a 10-week web-based program consisting of five modules with different themes that the participants were instructed to process during the course of two weeks.
The program was based on the processes of ACT and included themes such as life values, mindfulness, defusion, self-as-context acceptance and self-compassion.
The content of each module consisted of text, video, exercises with audio files, and homework assignments.
In addition, the participants filled in a diary with exercises in paper format.
The intervention included also three remote meetings (à 45 minutes) via a videoconferencing tool doxy.me
conducted by a psychologist.
The remote meetings took place at the beginning, after 4 weeks, and at the end of the intervention.
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Active Comparator: Psychoeducation
Group "Psychoeducation" will receive a self-help booklet and a link to mobile wellness training program
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The psychoeducation group received a self-help booklet and a link to a web-based wellness training program.
The program included exercises with MP3 audio files.
No personal support during the 10-week intervention was provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burnout
Time Frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
|
Burnout symptoms were measured with the Shirom-Melamed Burnout Questionnaire (SMBQ, Lundgren-Nilsson, Jonsdottir, Pallant, & Ahlborg, 2012; Melamed et al., 1999; Shirom & Melamed, 2006).
The SMBQ measures four elements of burnout; Emotional exhaustion and physical fatigue, Listlessness, Tension, and Cognitive weariness.
The SMBQ consists of 22 items that are rated on a seven-point scale ranging from 1 'Never or almost never' to 7 'Always or almost always'.
High scores correspond to more burnout symptoms.
The cut-off scores for burnout on the SMBQ are 2.75 - 3.74 indicating low burnout, 3,75 - 4,46 indicating high burnout and ≥ 4.47 indicating pathological level of burnout.
SMBQ's psychometric characteristics and factorial validity have been supported (Lundgren-Nilsson et al., 2012; Shirom & Melamed, 2006).
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Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression (PHQ-9)
Time Frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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The PHQ-9 is one module of the larger Patient Health Questionnaire (Spitzer, Williams, & Kroenke, 2001), a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
The PHQ-9 comprises nine items that evaluate the presence of the nine Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (APA, 2000a) criteria for major depressive disorder in the previous 2 weeks.
Each item of the PHQ-9 is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), for a total score ranging from 0 to 27.
A final item assesses the perception of social, functional, and occupational impairment caused by the symptoms examined by the PHQ-9.
Higher scores indicate an increased severity of depression symptoms .
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Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Health-related quality of life (RAND-36) Health-related quality of life (RAND-36) Health-related quality of life (RAND-36)
Time Frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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The health-related quality of life (HRQL) will be measured with the Short-form 36 (SF-36), which is a validated and widely used generic quality of life questionnaire with good reliability.
It consists of 36 questions measuring eight dimensions of quality of life: physical functioning, role functioning, pain, general health, vitality, social functioning, role functioning and mental health.
Physical and mental component summary scores will be calculated.
All 36 questions are scored on a scale from 0 to 100.
Each scale is directly transformed into a 0-100 scale, with 100 representing the highest level of functioning possible.
Lower scores indicate a worse outcome, i.e. more disability.
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Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Mindfulness (FFMQ)
Time Frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Mindfulness was assessed by the Five Facet Mindfulness Questionnaire (FFMQ, Baer et al., 2006). It includes 39-items that are rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of mindfulness skills. It includes the following elements. (a) Observing (b) Describing (c) Acting with awareness means (d) Non-judgment of inner experiences toward inner experiences. (e) Non-reactivity to inner experiences. The structure, reliability and validity of FFMQ have been supported (Baer et al., 2008).Higher scores indicate a better outcome, i.e. better mindfulness skills. Mindfulness was assessed by the Five Facet Mindfulness Questionnaire (FFMQ, Baer et al., 2006). It includes 39-items |
Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Psychological flexibility and ACT-related processes (CompACT)
Time Frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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The Comprehensive Assessments of Acceptance and Commitment Therapy processes (CompACT; Francis et al., 2016) is a self-report questionnaire, with 23-items on a 7-points likert scale (0 = Strongly disagree, 6 = Strongly agree).
The three-factor structure of the CompACT is concordant with recent accounts of psychological flexibility in terms of three dyadic processes; defined as: (1) openness to experience (acceptance; defusion); (2) behavioral awareness (present moment awareness; self as context); and (3) valued action (values; committed action).
Higher scores in the full-scale (max 138 points) and on the subscales (Openness to experience, max 60 points, behavioral awareness, max 30 points, and valued action, max 48 points) indicate greater psychological flexibility, ie. a better outcome.
These factors have demonstrated strong internal consistency.
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Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Health-related quality of life in children (KINDL)
Time Frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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The KINDL questionnaire is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17.
There are three different versions of the instrument suitable for different age groups and developmental stages.
Each version of the questionnaire can be completed both by children and adolescents, and also by their parents.
The KINDL-questionnaire comprises twenty-four items yielding six dimensions (physical health, general health, family functioning, self-esteem, social functioning and school functioning) and a total score.
The total score is transformed to a scale of 0-100 such that higher score represents a better outcome, i.e. better HRQoL.
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Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Raimo Lappalainen, PhD, Department of Psychology, UNiversity of Jyvaskyla
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
- 18/26/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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