Psychoeducation in Parents of Children With ADHD

October 22, 2019 updated by: Gül Dikec, Saglik Bilimleri Universitesi

The Effect of Psychoeducation on Stress in Parents of Children With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34036
        • Gül Dikeç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Two sessions of psychoeducation were given to the parents in the experimental group.
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.
No Intervention: Control Group
The parents in the control group did not undergo any intervention and the children of the parents in this group continued their current treatment plans.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caregiver Stress
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gül Dikeç, PhD, Saglık Bilimleri University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO2017/9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings