ADHDNCT04138108
Psychoeducation in Parents of Children With ADHD
A study testing Psychoeducation in people with ADHD and Parents, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Psychoeducation
- Keywords
- Childhood illness, Stress, Parents, Psychiatric Nursing
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Two sessions of psychoeducation were given to the parents in the experimental group. Receives: Other: Psychoeducation |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start3 Mar 2017
- Primary completion1 May 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gül Dikec, Saglik Bilimleri Universitesi
- Investigators
- Gül Dikeç, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138108
- Sponsor's protocol ID
- GO2017/9
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation on Stress in Parents of Children With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04138108
- Acronym / sponsor ID
- GO2017/9
- Keywords
- Childhood illness, Stress, Parents, Psychiatric Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: PsychoeducationTwo sessions of psychoeducation were given to the parents in the experimental group. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationThe 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. | Other | Experimental Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gül Dikeç, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with ADHD and Parents, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Stress (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.