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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547945
• Other study ID #: ADHD20180516
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: Taipei Medical University
• Contact: Hsiu-ju Chang, Professor
• Phone: 02-28267000
• Email: hsiuju26[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Caregiver Stress Syndrome

Intervention

Behavioral:
• 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.
• Control group
The control group received as usual care.

Locations

Country	Name	City	State
Taiwan	Wan Fang Hospital, Taipei Medical University	Taipei	Wenshan District

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	ADHD symptoms	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