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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04138108
Other study ID # GO2017/9
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2017
Est. completion date September 1, 2019

Study information

Verified date October 2019
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to determine the effect of psychoeducation on the stress levels of parents of children with Attention Deficit and Hyperactivity Disorder (ADHD). This was a randomised controlled study and applied the Consolidated Standards of Reporting Trials (CONSORT) statement. A total of 172 parents (experimental group: 86, control group: 86) participated in the study, which was planned as an experimental (randomized controlled, with pre-test-post-test control group, follow-up) study. Both the mothers and fathers were included in the psychoeducation program for parents which was delivered in two sessions per week. The study was evaluated before the first session, after the second session and at the 6th month. Data were collected using the Personal Information Form and Caregiver Stress Scale (CSS). Mean, standard deviation, number and percentage, minimum, maximum, homogeneity tests and the chi-square test were used for data analysis.


Description:

Psychoeducation given to the parents of the children with ADHD reduce parental stress, but these reduces are not proven for parents of the children with ADHD. The objective of this study was to determine the effect of psychoeducation on the stress levels of parents of children with Attention Deficit and Hyperactivity Disorder (ADHD). This was a randomised controlled study and applied the Consolidated Standards of Reporting Trials (CONSORT) statement. A total of 172 parents (experimental group: 86, control group: 86) participated in the study, which was planned as an experimental (randomized controlled, with pre-test-post-test control group, follow-up) study. Both the mothers and fathers were included in the psychoeducation program for parents which was delivered in two sessions per week. The study was evaluated before the first session, after the second session and at the 6th month. Data were collected using the Personal Information Form and Caregiver Stress Scale (CSS). Mean, standard deviation, number and percentage, minimum, maximum, homogeneity tests and the chi-square test were used for data analysis. The mean scores obtained from the scales before and after the training were compared with the paired-t test and student t test between the groups. There was no significant difference between the mean pre-test scores of the parents in the experimental and control groups on the whole CSS (p<0.005). Significant differences were found between the scores before and after the psychoeducation, and their six-month follow-up scores (p<0.001). There were significant differences between the pre- and post-test scores, pre-test scores and six-month follow-up scores, and post-test scores and six-month follow-up scores of the parents in the experimental group according to the in-group comparisons (p>0.05). It was determined that psychoeducation given to parents of children with ADHD reduced parental stress.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date September 1, 2019
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- having a child diagnosed with ADHD at least six months previously who was receiving standardized clinical follow-up and clinical treatment,

- being in the 18-65 age range,

- having no mental illness,

- agreeing to participate in the study

Exclusion Criteria:

- having a child without ADHD or having a child diagnosed with ADHD at least under six months previously who was receiving standardized clinical follow-up and clinical treatment,

- being younger 18 years and older 65 years,

- having a mental illness,

- agreeing not to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Psychoeducation
The parents of each child were educated as couples and each training session lasted 45-60 minutes for each family. Approximately the first five minutes of the training were used for warm-up, 25 minutes were used for basic ADHD knowledge and the last 15 minutes were catechetic and conducted interactively. The psychoeducation included discussion about the causes, symptoms and signs of ADHD, the course and characteristics of the disease according to age, the treatment process, the drugs used in the treatment and their side effects, correct and incorrect information about drugs, the other symptoms which can coexist with ADHD and their treatment, and what the parents can do about these issues.

Locations

Country Name City State
Turkey Gül Dikeç Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caregiver Stress The parents stress levels were evaluated with Caregiver Stress Scale. The data collected from experimental group before and after psychoeducation program and 6 months later. However, parents in control group had pretest and posttest at 6 months follow-up. 6 months
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