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

NCT05547945 | Unknown

• 1 other identifier: ADHD20180516
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Caregiver Stress Syndrome

Keywords

ADHD; Caregiver; Health Promotion Program

Outcome Measures

Primary Outcomes (3)

• 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.

  5 minutes

• 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.

  5 minutes

• Health-Promotion Lifestyle Profile

  It has a total of 40 questions including of self-actualization, health-responsibility, exercise, nutrition, interpersonal support, stress management.

  5minutes

Secondary Outcomes (1)

• ADHD symptoms

  5 minutes

Study Arms (2)

health promotion program

OTHER

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.

Behavioral: Health Promotion Program; Behavioral: Control group

Control group

NO INTERVENTION

The control received as usual care.

Interventions

Health Promotion Program 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.

Also known as: Experimental group

health promotion program

Control group BEHAVIORAL

The control group received as usual care.

Also known as: Usual care

health promotion program

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The primary caregivers who came to the out-patient department first time due to an undetermined diagnosis of ADHD
• Presence of the intellectual disability

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Wan Fang Hospital, Taipei Medical University

Taipei, Wenshan District, 116, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 23545375 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Hsiu-ju Chang, Professor

CONTACT

02-28267000; hsiuju26@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: September 7, 2022
• First Posted: September 21, 2022
• Study Start: May 19, 2018
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)