Clinical trial NCT04250012: Web-based ACT to Support Parents With Children With Chronic and Developmental Conditions
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout Syndrome
Psychological Distress
Depressive Symptoms
Quality of Life
Keywords: Parents, burnout, parental distress, Internet-based, ACT
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: The Gerocenter Foundation for Research and Development
name: Social Insurance Institution, Finland
First posted: 2020-01-31
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parents of children with a chronic disease or functional disabilities have an increased risk of stress-related distress and reduced quality of life. Internet-delivered interventions are one way to reach out to exhausted parents who may often have challenges in finding time to access face-to-face services. We developed a guided web-based Acceptance and Commitment Therapy intervention for Finnish parents of children with chronic conditions or functional disabilities. Participants (N=100) will be recruited on parent associations' Facebook groups and randomly assigned to guided web-based ACT condition and a control condition receiving psychoeducation. The guided web-based ACT condition will receive a 10-week web intervention including three remote meetings with a psychologist through the telemedicine application Doxy.me. Symptoms of burnout (SMBQ), depression (PHQ), health-related quality of life (RAND-36), mindfulness (FFMQ), general measure of psychological flexibility (CompACT) as well as the wellbeing of their child (KINDL) will be measured before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. In this randomized controlled trial we will investigate the outcomes and the mechanisms of change of the web-based ACTintervention. In addition, we will examine the acceptability of the web-based intervention.

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:

1. 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?
2. Which psychological processes (i.e., psychological flexibility, mindfulness skills, cognitive strategies) act as mediators of change?
3. Do the changes in the well-being of the parents improve the quality of life of the child?
4. How do parents experience online intervention and what kind of parent group especially will benefit from online support?

Eligibility criteria: 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.

Primary outcomes:
measure: Burnout
timeFrame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Secondary outcomes:
measure: Depression (PHQ-9)
timeFrame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
measure: Health-related quality of life (RAND-36) Health-related quality of life (RAND-36) Health-related quality of life (RAND-36)
timeFrame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
measure: Mindfulness (FFMQ)
timeFrame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
measure: Psychological flexibility and ACT-related processes (CompACT)
timeFrame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
measure: Health-related quality of life in children (KINDL)
timeFrame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Department of Psychology, University of Jyväskylä
Study officials:
affiliation: Department of Psychology, University of Jyväskylä
name: Raimo Lappalainen, PhD
role: STUDY_DIRECTOR
References: