NCT04138108

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

October 22, 2019

Last Update Submit

October 22, 2019

Conditions

ADHDParents

Keywords

Childhood illnessStressParentsPsychiatric Nursing

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Two sessions of psychoeducation were given to the parents in the experimental group.

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.

Interventions

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.

Experimental Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gül Dikeç

Istanbul, 34036, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Gül Dikeç, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Nursing

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

March 3, 2017

Primary Completion

May 1, 2018

Study Completion

September 1, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

TU(1)