The Effects of Health Promotion Program for the Caregivers of Attention Deficit/Hyperactivity Disorders Children
Primary Purpose
ADHD, Caregiver Stress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health Promotion Program
Control group
Sponsored by
About this trial
This is an interventional other trial for ADHD focused on measuring ADHD, Caregiver, Health Promotion Program
Eligibility Criteria
Inclusion Criteria:
- Ages 20-65 years
- Being primary caregivers of children diagnosed with ADHD confirmed using DSM-IV aged 7-12 years
- Living together with the children and spending most of the time caring for children with ADHD among caregivers
- Being able to communicate by reading, listening and writing Chinese.
Exclusion Criteria:
- The primary caregivers who came to the out-patient department first time due to an undetermined diagnosis of ADHD
- Presence of the intellectual disability
Sites / Locations
- Wan Fang Hospital, Taipei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
health promotion program
Control group
Arm Description
The health promotion program included knowledge guidance on ADHD disease, physical activity, diet nutrition, parental training/stress adjustment, related social welfare resources, mindfulness relaxation, and yoga.
The control received as usual care.
Outcomes
Primary Outcome Measures
The Parenting Stress Scale (Short form)
Our study used a modified version of the parenting stress scale (Liu, 2015) which had 24 questions. The modified version of Abdin's short-term version of the parental stress scale is divided into three factors, including of parental distress, parent-child dysfunctional interaction, and difficult child.
The Taiwan's Concise World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
It had 28 questions, which are similar and well psychometrically measured to the global version of the questionnaire.
Health-Promotion Lifestyle Profile
It has a total of 40 questions including of self-actualization, health-responsibility, exercise, nutrition, interpersonal support, stress management.
Secondary Outcome Measures
ADHD symptoms
The Swanson, Nolan and Pelham, Version IV, SNAP-IV (Liu et al., 2006) The common version is a total of 26 questions for the SNAP-IV MTA, aged 6-13year-old children, including inattention subscales (1-9 questions), hyperactivity/impulse subscales (10-18 questions), and opposite subscales (19-26 questions).
Full Information
NCT ID
NCT05547945
First Posted
September 7, 2022
Last Updated
September 18, 2022
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05547945
Brief Title
The Effects of Health Promotion Program for the Caregivers of Attention Deficit/Hyperactivity Disorders Children
Official Title
The Effects of Health Promotion Program for the Caregivers of Attention Deficit/Hyperactivity Disorders Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: To explore the effect of health promotion programs on parental stress, quality of life, and health-promoting lifestyles for primary caregivers who had children with ADHD. Children's ADHD symptoms were also examined.
Methods: A randomized control trial was conducted between July 2017 and April 2018. Primary caregivers aged 20 to 65 years who had ADHD children aged 7 to 12 years were recruited from a psychiatric outpatient department. Sixty caregivers were randomized to the health promotion group intervention (n=30) and the control groups (n=30). The control group received usual care. Study instruments included the Swanson, Nolan, Pelham, Version IV (SNAP-IV), Parenting Stress Scale (Short form), Taiwan's Concise World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), and Health-Promotion Lifestyle Profile.
Both groups were evaluated before and immediately after the intervention at 1, 3, and 6 months. GEE was applied for statistical analysis.
Results: 60 participants were randomized to the health promotion intervention (n=30) or the control group (n=30). To explore the effect of health promotion programs on parental stress, quality of life, and health-promoting lifestyles for primary caregivers who are caring for children with ADHD.
Conclusion: We hope that the Health promotion program could demonstrate the effect in reducing parental stress, improving the quality of life, promoting healthy lifestyles for primary caregivers, and reducing the symptoms of children with ADHD. Proper intervention programs should be incorporated in clinical practice settings in order to facilitate mental health well-being for caregivers of ADHD children.
Detailed Description
Objective: To explore the effect of health promotion programs on parental stress, quality of life, and health-promoting lifestyles for primary caregivers who had children with ADHD. Children's ADHD symptoms were also examined.
Methods: A randomized control trial was conducted between July 2017 and April 2018. Primary caregivers aged 20 to 65 years who had ADHD children aged 7 to 12 years were recruited from a psychiatric outpatient department. Sixty caregivers were randomized to the health promotion group intervention (n=30) and the control groups (n=30). The control group received usual care. Study instruments included the Swanson, Nolan, Pelham, Version IV (SNAP-IV), Parenting Stress Scale (Short form), Taiwan's Concise World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), and Health-Promotion Lifestyle Profile.
Both groups were evaluated before and immediately after the intervention at 1, 3, and 6 months. GEE was applied for statistical analysis.
Results: 60 participants were randomized to the health promotion intervention (n=30) or the control group (n=30). To explore the effect of health promotion programs on parental stress, quality of life, and health-promoting lifestyles for primary caregivers who are caring for children with ADHD.
Conclusion: We hope that the Health promotion program could demonstrate the effect in reducing parental stress, improving the quality of life, promoting healthy lifestyles for primary caregivers, and reducing the symptoms of children with ADHD. Proper intervention programs should be incorporated in clinical practice settings in order to facilitate mental health well-being for caregivers of ADHD children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Caregiver Stress Syndrome
Keywords
ADHD, Caregiver, Health Promotion Program
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sixty caregivers were randomized to the health promotion group intervention (n=30) and the control groups (n=30). The control group received usual care.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
This study used a randomized control trial design to perform simple sampling with using computer random sampling. Due to research recruitment, treatment intervention, and follow-up data tracking are different researchers, a single blind could reduce interference. The randomization procedure of this study was handled by the trained researcher. The researchers were responsible for different research interventions and data collection. The randomization of the password was not released during the study intervention to ensure the purpose of the randomization.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
health promotion program
Arm Type
Other
Arm Description
The health promotion program included knowledge guidance on ADHD disease, physical activity, diet nutrition, parental training/stress adjustment, related social welfare resources, mindfulness relaxation, and yoga.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control received as usual care.
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion Program
Other Intervention Name(s)
Experimental group
Intervention Description
The health promotion program included knowledge guidance on ADHD disease, physical activity, diet nutrition, parental training/stress adjustment, related social welfare resources, mindfulness relaxation, and yoga.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Other Intervention Name(s)
Usual care
Intervention Description
The control group received as usual care.
Primary Outcome Measure Information:
Title
The Parenting Stress Scale (Short form)
Description
Our study used a modified version of the parenting stress scale (Liu, 2015) which had 24 questions. The modified version of Abdin's short-term version of the parental stress scale is divided into three factors, including of parental distress, parent-child dysfunctional interaction, and difficult child.
Time Frame
5 minutes
Title
The Taiwan's Concise World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Description
It had 28 questions, which are similar and well psychometrically measured to the global version of the questionnaire.
Time Frame
5 minutes
Title
Health-Promotion Lifestyle Profile
Description
It has a total of 40 questions including of self-actualization, health-responsibility, exercise, nutrition, interpersonal support, stress management.
Time Frame
5minutes
Secondary Outcome Measure Information:
Title
ADHD symptoms
Description
The Swanson, Nolan and Pelham, Version IV, SNAP-IV (Liu et al., 2006) The common version is a total of 26 questions for the SNAP-IV MTA, aged 6-13year-old children, including inattention subscales (1-9 questions), hyperactivity/impulse subscales (10-18 questions), and opposite subscales (19-26 questions).
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 20-65 years
Being primary caregivers of children diagnosed with ADHD confirmed using DSM-IV aged 7-12 years
Living together with the children and spending most of the time caring for children with ADHD among caregivers
Being able to communicate by reading, listening and writing Chinese.
Exclusion Criteria:
The primary caregivers who came to the out-patient department first time due to an undetermined diagnosis of ADHD
Presence of the intellectual disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiu-ju Chang, Professor
Phone
02-28267000
Ext
67243
Email
hsiuju26@nycu.edu.tw
Facility Information:
Facility Name
Wan Fang Hospital, Taipei Medical University
City
Taipei
State/Province
Wenshan District
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen-Chieh Chang, Attending physician
Email
cjosef@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23545375
Citation
Charach A, Carson P, Fox S, Ali MU, Beckett J, Lim CG. Interventions for preschool children at high risk for ADHD: a comparative effectiveness review. Pediatrics. 2013 May;131(5):e1584-604. doi: 10.1542/peds.2012-0974. Epub 2013 Apr 1.
Results Reference
result
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The Effects of Health Promotion Program for the Caregivers of Attention Deficit/Hyperactivity Disorders Children
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