Clinical trial NCT04991649: ACT for Parents of Children With Neurodevelopmental Comorbidities
Official title: Effects of Acceptance and Commitment Therapy-based Asthma Management Training Program for Parents of Young Children With Neurodevelopmental Comorbidities: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Attention Deficit Hyperactivity Disorder
Keywords: Acceptance and Commitment Therapy
Asthma
Attention Deficit Hyperactivity Disorder
Randomized Controlled Trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tuen Mun Hospital
First posted: 2021-08-05
Enrollment: 118
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment; repeated-measures 2-arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to examine the effectiveness of the Acceptance and Commitment Therapy-based Asthma Management Training Program on the health outcomes of asthmatic children with attention deficit hyperactivity disorder (ADHD) and their caregivers over a 12-month post-intervention.

Detailed description: Background: Attention deficit hyperactivity disorder and asthma are two of the most common pediatric chronic conditions. A meta-analysis of 49 datasets worldwide and a population-based cohort analysis of 1.5 million individuals showed an adjusted OR of 1.6 for ADHD during school years if the child has asthma at early childhood. Multiple mechanisms underlying this temporal association have been suggested, including the impacts of inflammatory mechanism or immune dysregulation on brain development, as well as the chronic sleep disruption after allergic symptoms. Compared with children with only asthma, asthmatic children with neurodevelopmental diseases have a higher risk of emergency care visits due to an asthma attack (adjusted prevalence = 1.5). Although the exact mechanism is still unclear, it has been shown that parents' psychological difficulties play an influential role in the cascade of family, biological and psychological influences on children's asthma. Compared with non-ADHD families, parents of children with ADHD have higher parenting stress, and the risk of depression/anxiety is almost tripled. Due to parental distress, these parents may weaken their motivation and coping ability to manage childhood asthma, leading to poor asthma outcomes.

Although studies have shown that asthma education and parental programs are effective ways to improve asthma management skills and parenting skills, none of these interventions addresses the psychological needs of parents when dealing with children with ADHD. This study is a randomized controlled trial designed to examine the effectiveness of the family-based asthma management program in Hong Kong that uses Acceptance and Commitment Therapy (ACT) in fostering parents' psychological flexibility, bettering their psychological difficulties acceptance, and striving toward values-based goals to healthy functioning. It is expected that the ACT-based asthma management training program can help parents to be aware of their emotional state when interacting with asthmatic children with ADHD enabling them to effectively implement the children's asthma management and parenting skills they have learned, leading to the ultimate improvement of children's health outcomes. If it is found that the plan can effectively improve their lives by addressing the unmet psychological needs of parents of asthmatic children with ADHD, it can be incorporated into existing services in hospitals and community settings in Hong Kong and other Chinese communities.

Aim and hypothesis to be tested: When compared with the treatment-as-usual group, participants in the ACT-based Asthma Management Training Program will:

1. reduce asthmatic children' unscheduled visits due to his/her asthma exacerbations,
2. reduce asthmatic children' asthma symptoms,
3. reduce asthmatic children' ADHD symptoms,
4. reduce asthmatic children' asthma-related behavioral problems,
5. improve asthmatic children' caregivers' psychological flexibility and adjustment,
6. enhance parenting competence, parental asthma management self-efficacy, and parental and family functioning

Design: An randomized controlled trial with a two-arm and repeated-measures design

Participants: 118 Cantonese-speaking asthmatic children aged 3 - 12 years old with ADHD condition and their primary caregiver.

Instruments: Validated questionnaires

Interventions: The ACT-based Asthma Management Training Program consists of a two-weekly group Positive Parenting Program (Triple-P) workshop and a four-weekly group Acceptance and Commitment Therapy (ACT) program.

Primary outcome measure: Children's unplanned health care service visits due to asthma exacerbations over 12 months

Expected results: After participating in the ACT-based asthma management program, parents will become more psychologically flexible in caring for children with asthma comorbid with ADHD. Parents also acquire better parenting competence and children's asthma management skills, improving parental and family functioning and child health outcomes.:

Eligibility criteria: Inclusion Criteria:

* Children between the age 3 and 12
* Age of the child's primary caregiver between the age 18 and 65
* Diagnosed as asthma by a physician (ICD-10 codes J45, J46) as documented in his/her medical records as well as reported score more or equal 19 in the Childhood Asthma Control Test (C-CAT, or Asthma Control Test for child aged 12) indicating not well-controlled.
* Co-occur with a diagnosis with the attention deficit and hyperactivity disorder (ADHD) as documented in the patient history profile of the medical record by a child psychiatrist/medical doctor according to the criteria set forth by the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; American Psychiatric Association \[APA\], 2013) or ICD-10.

Exclusion Criteria:

* Participant and/or his/her primary caregiver currently participate in another asthma-related intervention study
* Participant is under the care due to significant medical morbidities, including congenital problems, oxygen-dependent conditions, or the presence of a tracheotomy

Primary outcomes:
measure: The frequency of the unscheduled childhood asthma exacerbations visits
timeFrame: Change from baseline assessment to 12 months post-intervention
Secondary outcomes:
measure: Child's asthma symptoms
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Child's asthma-related behavioral problems
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Child's ADHD symptoms
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Parent's psychological flexibility
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Parent's psychological adjustment to the child's illness
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Parent's parenting competence
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Parent's asthma management self-efficacy
timeFrame: Change from baseline assessment to 12 months post-intervention
measure: Parental and family functioning
timeFrame: Change from baseline assessment to 12 months post-intervention
Other outcomes:
Locations:
city: Tuen Mun
country: Hong Kong
facility: Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Yuen Yu CHONG, PhD
role: PRINCIPAL_INVESTIGATOR
References: