ACT for Parents of Children With Neurodevelopmental Comorbidities

NCT04991649 | Completed DMC

• 1 other identifier: 07181086
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children; Attention Deficit Hyperactivity Disorder

Keywords

Acceptance and Commitment Therapy; Asthma; Attention Deficit Hyperactivity Disorder; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• The frequency of the unscheduled childhood asthma exacerbations visits

  The frequency of unscheduled healthcare service visits due to asthma exacerbations, including the public/private hospital emergency department visits, general outpatient clinic visits and private practitioners' clinic visits, hospital admission, and hospital stay length, will be collected by retrieving their medical records. A lessened frequency of unscheduled childhood asthma exacerbations visits signifies improved prevention and management of asthma cases. Any data (especially related to private healthcare services) that cannot be retrieved by the aforementioned method will be collected through parent-report questionnaires over 12 months.

  Change from baseline assessment to 12 months post-intervention

Secondary Outcomes (8)

• Child's asthma symptoms

  Change from baseline assessment to 12 months post-intervention

• Child's asthma-related behavioral problems

  Change from baseline assessment to 12 months post-intervention

• Child's ADHD symptoms

  Change from baseline assessment to 12 months post-intervention

• Parent's psychological flexibility

  Change from baseline assessment to 12 months post-intervention

• Parent's psychological adjustment to the child's illness

  Change from baseline assessment to 12 months post-intervention

Study Arms (2)

ACT Group

EXPERIMENTAL

One two-weekly 2-hour of positive parenting program plus a four-weekly 2-hour group ACT program and routine pediatric asthma out-patient services, including medical follow-up, asthma education by Advanced Practice Nurse specialized in pediatric respiratory care, and referrals to community care/welfare by psychiatrist/medical social worker for parental training in ADHD care.

Behavioral: Acceptance and Commitment Therapy-based Asthma Management Training Program

Treatment-as-usual (TAU) Group

OTHER

Routine pediatric asthma out-patient services, including medical follow-up, asthma education by Advanced Practice Nurse specialized in pediatric respiratory care, and referrals to community care/welfare by psychiatrist/medical social worker for parental training in ADHD care.

Behavioral: Treatment-as-usual Group

Interventions

Acceptance and Commitment Therapy-based Asthma Management Training Program BEHAVIORAL

In addition to the routine pediatric asthma outpatient service as received with the TAU group, participants in the ACT group will additionally receive a two-weekly 2-hour Positive Parenting Program (Triple-P) and a four-weekly 2-hour ACT program (a total of six weekly sessions, 6-8 parents per group). The Triple-P aims to increase parental self-regulation and positive parenting practices to promote child cooperation, lead to consistent discipline and promote routines in childhood asthma management. On the other hand, The ACT sessions foster parents' psychological flexibility to cultivate non-judgmental acceptance of difficult parenting experiences, be mindful in daily parenting, develop an observer-self, and promote commitment to one's values.

Also known as: ACT Group

ACT Group

Treatment-as-usual Group BEHAVIORAL

Participants in the treatment-as-usual (TAU) group will receive routine pediatric asthma outpatient services. These services include regular follow-up appointments once every 3-6 months for reviewing the child's health conditions by pediatricians, refilling medications and asthma education (1.5-2 hours every 3-4 weeks) by Advanced Practice Nurse specialized in pediatric respiratory care, and referrals to community care/welfare services by psychiatrist/medical social worker for parental training in ADHD care.

Also known as: TAU Group

Treatment-as-usual (TAU) Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Tuen Mun Hospital: collaborator

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital

Tuenmen, Hong Kong

Location

Related Publications (1)

• Chong YY, Chien WT, Fung KP, Leung SP, Lam SY. Acceptance and Commitment Therapy-Based Parenting Program in Children With Co-Occurring Asthma and ADHD: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):846-856. doi: 10.1001/jamapediatrics.2025.1313.

  PMID: 40455452 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Asthma

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yuen Yu CHONG, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and researchers (and health care staff of the study hospital) are blind to the group assignment and intervention undertaken and concealed to the participant list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment; repeated-measures 2-arm randomized controlled trial

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 5, 2021
• Study Start: April 11, 2021
• Primary Completion: August 31, 2023
• Study Completion: March 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

HK (1)