The Effects of Health Promotion Program for the Caregivers of Attention Deficit/Hyperactivity Disorders Children

September 18, 2022 updated by: Chang, Hsiu-Ju, Taipei Medical University

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Wenshan District
      • Taipei, Wenshan District, Taiwan, 116
        • Recruiting
        • Wan Fang Hospital, Taipei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: health promotion program
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 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.
Other Names:
  • Experimental group
The control group received as usual care.
Other Names:
  • Usual care
NO_INTERVENTION: Control group
The control received as usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Parenting Stress Scale (Short form)
Time Frame: 5 minutes
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.
5 minutes
The Taiwan's Concise World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Time Frame: 5 minutes
It had 28 questions, which are similar and well psychometrically measured to the global version of the questionnaire.
5 minutes
Health-Promotion Lifestyle Profile
Time Frame: 5minutes
It has a total of 40 questions including of self-actualization, health-responsibility, exercise, nutrition, interpersonal support, stress management.
5minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADHD symptoms
Time Frame: 5 minutes
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).
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 19, 2018

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 18, 2022

First Posted (ACTUAL)

September 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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