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

NCT ID: NCT05547945

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-19

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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ADHD Caregiver Stress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type OTHER

Health Promotion Program

Intervention Type BEHAVIORAL

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.

Control group

Intervention Type BEHAVIORAL

The control group received as usual care.

Control group

The control received as usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Control group

The control group received as usual care.

Intervention Type BEHAVIORAL

Other Intervention Names

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Experimental group Usual care

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang, Hsiu-Ju

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wan Fang Hospital, Taipei Medical University

Taipei, Wenshan District, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsiu-ju Chang, Professor

Role: CONTACT

02-28267000 ext. 67243

Facility Contacts

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Shen-Chieh Chang, Attending physician

Role: primary

References

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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.

Reference Type RESULT
PMID: 23545375 (View on PubMed)

Other Identifiers

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ADHD20180516

Identifier Type: -

Identifier Source: org_study_id

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