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

Sponsor

Taipei Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05547945

Collaborator

(none)

Enrollment

Location

Arms

52.4

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD Caregiver Stress Syndrome	Behavioral: Health Promotion Program Behavioral: Control group	N/A

Detailed Description

Both groups were evaluated before and immediately after the intervention at 1, 3, and 6 months. GEE was applied for statistical analysis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.Sixty caregivers were randomized to the health promotion group intervention (n=30) and the control groups (n=30). The control group received usual care.

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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 19, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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. Other Names: Experimental group Behavioral: Control group The control group received as usual care. Other Names: Usual care
No Intervention: Control group The control received as usual care.

Arm

Intervention/Treatment

Other: 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.

Behavioral: Health Promotion Program

Other Names:

Experimental group

Behavioral: Control group

The control group received as usual care.

Other Names:

Usual care

No Intervention: Control group

The control received as usual care.

Outcome Measures

Primary Outcome Measures

The Parenting Stress Scale (Short form) [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) [5 minutes]
It had 28 questions, which are similar and well psychometrically measured to the global version of the questionnaire.
Health-Promotion Lifestyle Profile [5minutes]
It has a total of 40 questions including of self-actualization, health-responsibility, exercise, nutrition, interpersonal support, stress management.

Secondary Outcome Measures

ADHD symptoms [5 minutes]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wan Fang Hospital, Taipei Medical University	Taipei	Wenshan District	Taiwan	116

Sponsors and Collaborators

Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang, Hsiu-Ju, Professor, Taipei Medical University

ClinicalTrials.gov Identifier:

NCT05547945

Other Study ID Numbers:

ADHD20180516

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chang, Hsiu-Ju, Professor, Taipei Medical University

ADHD

Caregiver

Health Promotion Program

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Sep 21, 2022