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An Internet-delivered Intervention for Parents of Children With ADHD (ADHDCoach)

Primary Purpose

ADHD

Status
Active
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
ADHDCoach
Treatment as usual
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Internet intervention, individually-tailored intervention, parental distress, ADHD, children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parent of a child diagnosed with ADHD
  • Child aged between 5-11 years
  • Have Internet access
  • Have ability to read and write in Romanian
  • No medication/ or stable dose of pharmacological treatment

Exclusion Criteria:

  • Other ongoing psychological treatment or counselling for mental health problems (currently undergoing psychotherapy or participating in a parenting program for child ADHD)
  • Recent (within the past 3 months) changes in the dose of medication
  • Serious psychopathology requiring immediate clinical attention (e.g., severe depressive symptoms)

Sites / Locations

  • Babes-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADHDCoach

Treatment as usual

Arm Description

Participants in the experimental group will have access to an individually-tailored Internet intervention developed for the present study. The intervention in clinician-guided and it consists of nine modules delivered for four weeks. The Internet Intervention, called ADHDCoach, is based on an existent Behavioral Parent training protocol, an intervention that was previously tested in a randomized controlled trial with Romanian children. The contents for parent modules were developed according to Rational Emotive and Behavioral Therapy.

Treatment as usual at the outpatient clinic

Outcomes

Primary Outcome Measures

Changes in parental psychological distress
The Patient Health Questionnaire will be used to assess changes in parental anxiety and depressive symptoms from pre-treatment to post-treatment and follow-up. Scores range between 0 and 12, higher scores indicate higher anxiety and depressive symptoms.

Secondary Outcome Measures

Changes in child ADHD symptoms
The ADHD Rating Scale-5 Home version is a 18 items scale measuring Inattention and Hyperactivity in children. Scores range from 0 to 54, higher scores indicate higher ADHD symptoms.
Changes in parenting
The Alabama Parenting Questionnaire- short form consists of 9 items rated on a 5 points Likert scale (1 - Never, 5 - Always). Scores will be reported for positive parenting, poor monitoring and inconsistent discipline. For each subscale, scores range between 1 and 15. Higher scores for positive parenting subscale indicate higher positive parenting practices, while higher scores for poor monitoring and inconsistent discipline indicate higher negative parenting practices.
Changes in parent-child closeness
Parent-child closeness will be measured via three items in line with previous research. Answers are rated on a 5-point Likert scale, ranging from 1 (Never) to 5 (Always). Scores range from 0 to 15, higher scores indicate higher parent-child closeness.
ADHD adult
The Adult Self-Report Screening Scale for DSM-5 consists of 6 items, rated on a 5 points Likert scale (0 - Never, 4 - Very often). Scores range from 0 to 24. Higher scores indicate higher ADHD symptoms.
Changes in ADHD Knowledge
A knowledge test regarding ADHD symptoms, causes and treatment was developed for the presents study. The scale consists of 15 items with a True or False choice. Scores are also rated on the certainty of the answers provided. Total scores range from 0 to 15. Higher scores indicate a better knowledge regarding ADHD.
Satisfaction with the intervention
Client Satisfaction Questionnaire-8. Scores range between 0 and 32, higher scores indicate higher satisfaction with the intervention.

Full Information

First Posted
April 11, 2022
Last Updated
September 12, 2023
Sponsor
Babes-Bolyai University
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1. Study Identification

Unique Protocol Identification Number
NCT05341310
Brief Title
An Internet-delivered Intervention for Parents of Children With ADHD
Acronym
ADHDCoach
Official Title
A Virtual Clinic for Parents of Children With ADHD - an Individually-tailored Approach to Reduce Parental Distress
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aims of the present study is to investigate the efficacy of a co-designed individually-tailored Internet intervention for parents of children with ADHD.
Detailed Description
Attention/deficit-hyperactivity disorder is a prevalent mental health problem in children with a significant impact on children, families and society. Despite the fact that evidence-based treatment exists, with pharmacologic and non-pharmacologic options available, a significant percentage of children do not have access to treatment. Behavioral parent training is recommended as first line treatment for children with ADHD, however, parents face numerous challenges in access, and even when they access BPT, dropout rates are high. Technology could improve access to evidence-based treatments and surpass existent gaps. For instance, Internet interventions are associated with moderate to large effect sizes for anxiety and depressive symptoms in adults. Participants included in this study, namely parents of children diagnosed with ADHD (aged 6-11 years) will be randomized either to ADHDCoach intervention or Treatment as usual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Internet intervention, individually-tailored intervention, parental distress, ADHD, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHDCoach
Arm Type
Experimental
Arm Description
Participants in the experimental group will have access to an individually-tailored Internet intervention developed for the present study. The intervention in clinician-guided and it consists of nine modules delivered for four weeks. The Internet Intervention, called ADHDCoach, is based on an existent Behavioral Parent training protocol, an intervention that was previously tested in a randomized controlled trial with Romanian children. The contents for parent modules were developed according to Rational Emotive and Behavioral Therapy.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual at the outpatient clinic
Intervention Type
Behavioral
Intervention Name(s)
ADHDCoach
Intervention Description
ADHDCoach is an individually-tailored intervention to reduce parents' of children diagnosed with ADHD distress.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual in the outpatient clinic
Primary Outcome Measure Information:
Title
Changes in parental psychological distress
Description
The Patient Health Questionnaire will be used to assess changes in parental anxiety and depressive symptoms from pre-treatment to post-treatment and follow-up. Scores range between 0 and 12, higher scores indicate higher anxiety and depressive symptoms.
Time Frame
Baseline, 4 weeks and follow-up at 3 months after treatment termination
Secondary Outcome Measure Information:
Title
Changes in child ADHD symptoms
Description
The ADHD Rating Scale-5 Home version is a 18 items scale measuring Inattention and Hyperactivity in children. Scores range from 0 to 54, higher scores indicate higher ADHD symptoms.
Time Frame
Baseline, 4 weeks and follow-up at 3 months after treatment termination
Title
Changes in parenting
Description
The Alabama Parenting Questionnaire- short form consists of 9 items rated on a 5 points Likert scale (1 - Never, 5 - Always). Scores will be reported for positive parenting, poor monitoring and inconsistent discipline. For each subscale, scores range between 1 and 15. Higher scores for positive parenting subscale indicate higher positive parenting practices, while higher scores for poor monitoring and inconsistent discipline indicate higher negative parenting practices.
Time Frame
Baseline, 4 weeks and follow-up at 3 months after treatment termination
Title
Changes in parent-child closeness
Description
Parent-child closeness will be measured via three items in line with previous research. Answers are rated on a 5-point Likert scale, ranging from 1 (Never) to 5 (Always). Scores range from 0 to 15, higher scores indicate higher parent-child closeness.
Time Frame
Baseline, 4 weeks and follow-up at 3 months after treatment termination
Title
ADHD adult
Description
The Adult Self-Report Screening Scale for DSM-5 consists of 6 items, rated on a 5 points Likert scale (0 - Never, 4 - Very often). Scores range from 0 to 24. Higher scores indicate higher ADHD symptoms.
Time Frame
Baseline, 4 weeks and follow-up at 3 months after treatment termination
Title
Changes in ADHD Knowledge
Description
A knowledge test regarding ADHD symptoms, causes and treatment was developed for the presents study. The scale consists of 15 items with a True or False choice. Scores are also rated on the certainty of the answers provided. Total scores range from 0 to 15. Higher scores indicate a better knowledge regarding ADHD.
Time Frame
Baseline, 4 weeks and follow-up at 3 months after treatment termination
Title
Satisfaction with the intervention
Description
Client Satisfaction Questionnaire-8. Scores range between 0 and 32, higher scores indicate higher satisfaction with the intervention.
Time Frame
At 4 weeks after treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent of a child diagnosed with ADHD Child aged between 5-11 years Have Internet access Have ability to read and write in Romanian No medication/ or stable dose of pharmacological treatment Exclusion Criteria: Other ongoing psychological treatment or counselling for mental health problems (currently undergoing psychotherapy or participating in a parenting program for child ADHD) Recent (within the past 3 months) changes in the dose of medication Serious psychopathology requiring immediate clinical attention (e.g., severe depressive symptoms)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Costina R Păsărelu, Ph.D
Organizational Affiliation
Babes-Bolyai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Babes-Bolyai University
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No

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An Internet-delivered Intervention for Parents of Children With ADHD

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