NCT06884007

Brief 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. 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: 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 12, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

ADHDchildcaregivertelepsychiatryvideoconference

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

    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)

  • Time-Related Changes in the Experimental Group

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

Study Arms (2)

Telepsychiatric Parent Training Program

EXPERIMENTAL

Participants 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.

Behavioral: Telepsychiatric Parent Training Program

Routine Care

ACTIVE COMPARATOR

Participants in this group continued with the routine treatment and services provided to caregivers of children with ADHD at the clinic.

Other: Routine Treatment

Interventions

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.

Telepsychiatric Parent Training Program

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

Routine Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Centrum, 35330, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 35021018BACKGROUND

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Zumra ULKER DORTTEPE, Dr.

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In this study, participants were not informed about which group they were assigned to (experimental or control), as this could have influenced their perception and response to the interventions. Participants were randomly assigned to either the experimental or control group by a third-party who was not involved in the study itself. Both the participants and the investigators who interacted with them during the study sessions were blinded to group assignments. Additionally, the outcomes assessor, who evaluated the primary and secondary outcomes, was also blinded to group assignment to ensure objective measurement of the effects of the intervention. This approach aimed to minimize bias and ensure the validity of the results by preventing the influence of prior expectations or knowledge on both participant behavior and data assessment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 19, 2025

Study Start

September 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Available IPD Datasets

https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp (https://tez.yok.gov.tr/UlusalT)Access

Locations