NCT02405962

Brief Summary

The purpose of this study is to examine whether a parental training program using group-based Acceptance and Commitment Therapy for childhood asthma care, is effective in reducing the children's unplanned health care services utilization and asthmatic symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

March 28, 2015

Results QC Date

September 20, 2017

Last Update Submit

January 24, 2019

Conditions

Childhood Asthma

Keywords

Acceptance and Commitment TherapyChildhood asthmaRandomized controlled trialTraining parents

Outcome Measures

Primary Outcomes (1)

  • Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention

    Parental report of the total number of emergency department visits due to asthma attacks of a child in either a / public hospital(s) of the Hong Kong Hospital Authority and/or a private hospital(s) over 6 months post intervention

    6 months after the completion of intervention

Secondary Outcomes (14)

  • Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months

    At 6 months after the intervention

  • Children's Total Number of Private Practitioner's Clinic Visits Due to Asthma Attacks Over the Past 6 Months

    At 6 months after the intervention

  • Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months

    At 6 months after the intervention

  • Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months

    At 6 months after the intervention

  • Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks

    At 6 months after the intervention

  • +9 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

Parents of children with asthma will receive one session of asthma educational talk as the usual care, plus three weekly sessions of telephone calls to assess the child's asthma symptoms

Behavioral: Control

ACT group

EXPERIMENTAL

Parents of children with asthma will receive four sessions of group-based ACT intervention integrated with asthma education (its content will be the same as that of the Control Group).

Behavioral: ACT

Interventions

ACTBEHAVIORAL

Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management.

ACT group
ControlBEHAVIORAL

One session of educational talk about pediatric asthma care, as the usual care. To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting.

Control group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between 18 and 65 years old
  • Fathers or mothers in each family who are primarily responsible for the daily care of their child with asthma
  • Living together with the index child
  • Able to communicate in Cantonese
  • Hong Kong residents who plan to stay in Hong Kong for at least 6 months
  • Accessible by telephone and by mail
  • to 12 years old with a physician's diagnosis of asthma

You may not qualify if:

  • Enrolled in another asthma research intervention study
  • Enrolled in another asthma research intervention study
  • Two years old or under presented with an acute wheezing attack. As symptoms at this age can be due to bronchiolitis, a viral infection, rather than asthma
  • Have (1) other chronic pulmonary diseases, such as cystic fibrosis (CF), bronchopulmonary dysplasia (BPD), oxygen dependent conditions, or presence of tracheotomy; (2) other significant medical and mental morbidities, such as congenital malformation, Down's syndrome, cerebral palsy and psychomotor retardation. Both may hinder the control of asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

Ambulatory Care Clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Pediatric asthma nurse-led clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Chong YY, Mak YW, Leung SP, Lam SY, Loke AY. Acceptance and Commitment Therapy for Parental Management of Childhood Asthma: An RCT. Pediatrics. 2019 Feb;143(2):e20181723. doi: 10.1542/peds.2018-1723. Epub 2019 Jan 18.

    PMID: 30659063DERIVED

Results Point of Contact

Title
Dr. Yim Wah Mak
Organization
The Hong Kong Polytechnic University
yw.mak@polyu.edu.hk
(852) 2766-6421

Study Officials

  • Yim Wah Mak, PhD

    School of Nursing, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 28, 2015

First Posted

April 1, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 12, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(3)