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Clinical Trials/NCT05547945
NCT05547945RecruitingNot Applicable

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

Taipei Medical University2 sites in 1 country60 target enrollmentStarted: May 19, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
2
Primary Endpoint
Health-Promotion Lifestyle Profile

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Care Provider, Investigator, Outcomes 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.

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • ADHD symptoms(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chang, Hsiu-Ju

Professor

Taipei Medical University

Study Sites (2)

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