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TelepsychotherapyTPT-ADHDNCT06884007

Effects of Telepsychiatric Parent Training on Caregivers of Children With ADHD (TPT-ADHD)

A study testing Telepsychiatric Parent Training Program and Routine Treatment in people with Telepsychotherapy and Attention Deficit Disorder With Hyperactivity (ADHD), run by Uşak University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was conducted to examine the effects of a telepsychiatric parent training program implemented for primary caregivers of children with Attention Deficit Hyperactivity Disorder (ADHD). The study employed a quasi-experimental pre-test, post-test, and re-test control group design. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telepsychiatric Parent Training Program and Routine Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2021to 31 Jul 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willingness to participate in the study.
  • Literacy skills (reading and writing ability).
  • A primary caregiver of a child diagnosed with ADHD (according to DSM V criteria), aged 7-12 years, currently on medication.
  • The primary caregiver must have been responsible for the child's care for at least 3 months.
  • The primary caregiver should be 18 years or older.

Who cannot join

  • The child has additional mental health conditions such as intellectual disability, psychotic disorders, post-traumatic stress disorder, bipolar disorder, obsessive-compulsive disorder, or pervasive developmental disorder.
  • The caregiver misses more than three sessions of the intervention.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dokuz Eylul University

    Izmir, Centrum, 35330

Other trials in Turkey (Türkiye)

About this study

Official title: Dikkat Eksikliği ve Hiperaktivite Bozukluğu Olan Çocukların Primer Bakım Verenlerinde Telepsikiyatrik Ebeveyn Eğitimi Programının Etkilerinin İncelenmesi

This study was conducted to examine the effects of a telepsychiatric parent training program implemented for primary caregivers of children with Attention Deficit Hyperactivity Disorder (ADHD).

The study employed a quasi-experimental pre-test, post-test, and re-test control group design. It was conducted from March to June 2022 via videoconferencing with primary caregivers of children aged 7-12 years diagnosed with ADHD, registered at the Child and Adolescent Mental Health Outpatient Clinic of Dokuz Eylül University Hospital. Caregivers in the experimental group completed Turkey's first "Telepsychiatric Parent Training" program, featuring nine 60-minute videoconference sessions. Data were collected using the "Descriptive Information Form," "Zarid Burden Interview (ZBI-22)," "Perceived Stress Scale (PSS-14)," and "Strengths and Difficulties Questionnaire (SDQ)." Data were collected before the program, after the program, and at the 2-month follow-up. The program was also implemented with caregivers in the control group after the research process was completed. Data from the experimental and control groups were analyzed using two-way mixed ANOVA. To determine the effect of the intervention, post-hoc power (β) analysis was conducted using the G*Power 3.1.9.7 program, and the level of statistical significance was set at 0.05. Study hypotheses are:

Read more

H1: There is a difference in the average scores of the Caregiving Burden Scale (CBS) for primary caregivers of children with ADHD based on time, group, and the group*time interaction after the application of a parent training program.

H2: There is a difference in the average scores of the Perceived Stress Scale (PSS-14) for primary caregivers of children with ADHD based on time, group, and the group*time interaction after the application of a parent training program.

H3: There is a difference in the average scores of the Strengths and Difficulties Questionnaire (SDQ) for primary caregivers of children with ADHD based on time, group, and the group*time interaction after the application of a parent training program.

All caregivers (100%) successfully completed the program. Caregivers showed significant improvements in caregiving burden, stress levels , and difficulties.

Read the detailed description

This study explores the effects of a telepsychiatric parent training program designed for primary caregivers of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that significantly impacts children's behavior, attention, and social interactions, leading to challenges for both the children and their caregivers. This study aimed to assess how a structured, remote training program could help caregivers manage these challenges by reducing caregiver burden, stress, and emotional difficulties.

The research employed a quasi-experimental design, involving both experimental and control groups to evaluate the program's effectiveness. The study was conducted from March to June 2022 with caregivers of children aged 7 to 12 years diagnosed with ADHD. Participants were recruited from the Child and Adolescent Mental Health Outpatient Clinic of Dokuz Eylül University Hospital.

Caregivers in the experimental group participated in Turkey's first "Telepsychiatric Parent Training" program, which consisted of nine 60-minute videoconference sessions. The program was delivered remotely, offering flexibility and ease of access for the participants. The training program was specifically designed to provide caregivers with practical tools and strategies for managing the behavioral challenges of children with ADHD. The sessions covered topics such as ADHD symptoms, parenting techniques, emotional regulation, and stress management.

To measure the effectiveness of the program, data were collected at three points: before the program, immediately after the program, and two months following the program. Several established scales were used to assess various aspects of the caregivers' experiences, including the Zarid Burden Interview (ZBI-22) to evaluate caregiving burden, the Perceived Stress Scale (PSS-14) to measure stress levels, and the Strengths and Difficulties Questionnaire (SDQ) to assess emotional and behavioral difficulties in the children. These tools provided a comprehensive view of the impact of the program on both the caregivers and the children.

The data analysis was conducted using two-way mixed ANOVA to assess the differences across time and between the experimental and control groups. The study's findings revealed significant improvements in caregiving burden, stress levels, and child difficulties, with statistical significance observed across pre-test, post-test, and follow-up measurements. These improvements were further supported by post-hoc power analysis, confirming the program's efficacy in addressing the challenges faced by caregivers of children with ADHD.

This study highlights the positive impact of telepsychiatric parent training on reducing stress, caregiving burden, and child difficulties. The success of this program suggests that similar telepsychiatric interventions can be a sustainable and effective model for supporting caregivers, particularly in settings where in-person interventions may be difficult. Additionally, the involvement of psychiatric nurses in delivering such programs may further enhance the effectiveness of the interventions.

Given that this program is the first of its kind in Turkey, it offers valuable insights into the feasibility and effectiveness of telepsychiatric parent training programs. The results support the idea that expanding such programs could provide significant benefits for caregivers, improving their mental health and quality of life while also benefiting the children they care for.

Future studies are recommended to explore the long-term effects of such interventions and assess their feasibility in a broader context, including different populations and settings. Overall, this research contributes to the growing field of telepsychiatry and offers a promising approach for supporting caregivers of children with ADHD.

Being tested
Telepsychiatric Parent Training Program, Routine Treatment
Keywords
ADHD, child, caregiver, telepsychiatry, videoconference
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.

  • Telepsychiatric Parent Training ProgramBehavioural

    This study involves a telepsychiatric parent training program for caregivers of children with ADHD. The program includes 9 sessions, each addressing specific topics related to managing ADHD-related behaviors and enhancing parenting strategies. Sessions are primarily delivered through a telepsychiatric platform, such as video conferencing (e.g., Zoom), with additional support provided through text-based communication via platforms like WhatsApp, and, when necessary, follow-up phone calls. The content covers behavior management techniques, stress coping strategies, and skills for managing emotional and behavioral issues in children with ADHD. This intervention is designed to provide accessible, flexible support to caregivers, enhancing their ability to manage their child's condition.

  • Routine TreatmentOther

    Routine treatment and services (no intervention, participants continue with their usual care)

Study groups in NCT06884007
Study groupRoleWhat they receive
Telepsychiatric Parent Training ProgramExperimentalParticipants in this group received Turkey's first "Telepsychiatric Parent Training" program, which consisted of nine 60-minute videoconference sessions aimed at improving caregiver burden, stress, and child behavioral difficulties.
Receives: Behavioral: Telepsychiatric Parent Training Program
Routine CareActive comparatorParticipants in this group continued with the routine treatment and services provided to caregivers of children with ADHD at the clinic.
Receives: Other: Routine Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Zarit Burden Interview (ZBI-22)

    This outcome measures the caregiver burden experienced by parents of children with ADHD. The ZBI-22 assesses various aspects of the emotional, physical, and social burden on caregivers. It evaluates the level of strain experienced by parents in relation to caregiving tasks and their well-being. The total burden score ranges from 0 to 88, with higher scores indicating a greater level of caregiver burden.

    Time Frame: The measurement will be taken at pre-test, post-test, and during a follow-up period after the intervention (i.e., 2 months post-intervention) to assess changes over time and group differences.

    Measured: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

  2. Perceived Stress (PSS-14)

    This outcome measures the perceived stress levels of caregivers using the PSS-14. The scale assesses the extent to which caregivers feel stress in their daily lives, particularly regarding the challenges of caring for children with ADHD. The total perceived stress score ranges from 0 to 56, with higher scores indicating greater perceived stress.

    Measured: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

  3. Emotional and Behavioral Issues in Children (SDQ)

    This outcome measures the emotional and behavioral issues in children with ADHD, as reported by their caregivers. The SDQ assesses various domains, including emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships, and prosocial behavior. The total difficulties score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral difficulties.

    Measured: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

Secondary outcomes (1)
  1. Time-Related Changes in the Experimental Group

    This outcome measures the changes in the primary scales (ZBI-22, PSS-14, SDQ) for the experimental group over the course of the study. Specifically, changes between pre-test, post-test, and 2-month follow-up are assessed.

    Measured: Baseline (Week 0), immediately after the intervention (Week 9), and follow-up at 2 months post-intervention (approximately Week 17).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start1 Sep 2021
  3. Primary completion30 Jun 2022
  4. Study completion31 Jul 2022

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study employed a parallel-group quasi-experimental design with a pre-test, post-test, and 2-month follow-up. Participants were assigned to either the experimental or control group. The experimental group received a telepsychiatric parent training program consisting of nine 60-minute videoconference sessions, while the control group continued receiving routine treatment and services without additional intervention during the study period. After the study was completed, the control group was also provided with the same training program. Data were collected at three time points: before the intervention, after the intervention, and at the 2-month follow-up. The study aimed to assess the effects of the intervention on caregiving burden, perceived stress, and child behavioral difficulties.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884007
Sponsor's protocol ID
3786-GOA
Other IDs
2022/3786-GOA
Acronym
TPT-ADHD
Status last verified
Mar 2025
First submitted
12 Mar 2025
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At this stage, a decision has not yet been made regarding the sharing of individual participant data (IPD) due to the need to review data security procedures to ensure the protection of participants' privacy. Additionally, the research data will be used solely for analysis within the study.

Publications

  • Dorttepe ZU, Duman ZC. Examination of Telemental Health Practices in Caregivers of Children and Adolescents with Mental Illnesses: A Systematic Review. Issues Ment Health Nurs. 2022 Jul;43(7):625-637. doi: 10.1080/01612840.2021.2013366. Epub 2022 Jan 12.

    PubMed 35021018

Questions about this trial

What is this clinical trial studying?

A study testing Telepsychiatric Parent Training Program and Routine Treatment in people with Telepsychotherapy and Attention Deficit Disorder With Hyperactivity (ADHD), run by Uşak University 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 5 inclusion and 2 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 19 Mar 2025. 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?

Zarit Burden Interview (ZBI-22) (time frame: Baseline (pre-test), immediately after the intervention (post-test, approximately Week 9), and follow-up at 2 months post-intervention (approximately Week 17).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06884007, which also lists 1 linked publication.

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 19 Mar 2025.

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