Clinical trial NCT05547945: 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
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Caregiver Stress Syndrome
Keywords: ADHD
Caregiver
Health Promotion Program
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The Parenting Stress Scale (Short form)
timeFrame: 5 minutes
measure: The Taiwan's Concise World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 5 minutes
measure: Health-Promotion Lifestyle Profile
timeFrame: 5minutes
Secondary outcomes:
measure: ADHD symptoms
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan Fang Hospital, Taipei Medical University
state: Wenshan District
Study officials:
References:
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.