ADHDADHDCoachNCT05341310
An Internet-delivered Intervention for Parents of Children With ADHD
A study testing ADHDCoach and Treatment as usual in people with ADHD, run by Babes-Bolyai University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- ADHDCoach and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2022to 30 Mar 2024
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Virtual Clinic for Parents of Children With ADHD - an Individually-tailored Approach to Reduce Parental Distress
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- ADHDCoach, Treatment as usual
- Keywords
- Internet intervention, individually-tailored intervention, parental distress, ADHD, children
- 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.
ADHDCoachBehavioural
ADHDCoach is an individually-tailored intervention to reduce parents' of children diagnosed with ADHD distress.
Treatment as usualOther
Treatment as usual in the outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| ADHDCoach | Experimental | 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. Receives: Behavioral: ADHDCoach; Other: Treatment as usual |
| Treatment as usual | Active comparator | Treatment as usual at the outpatient clinic Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Secondary outcomes (6)
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.
Measured: Baseline, 4 weeks and follow-up at 3 months after treatment termination
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.
Measured: Baseline, 4 weeks and follow-up at 3 months after treatment termination
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.
Measured: Baseline, 4 weeks and follow-up at 3 months after treatment termination
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.
Measured: Baseline, 4 weeks and follow-up at 3 months after treatment termination
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.
Measured: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Satisfaction with the intervention
Client Satisfaction Questionnaire-8. Scores range between 0 and 32, higher scores indicate higher satisfaction with the intervention.
Measured: At 4 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Mar 2022
- Primary completion20 Dec 2023
- Study completion30 Mar 2024
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costina-Ruxandra Poetar, Babes-Bolyai University
- Investigators
- Costina R Păsărelu, Ph.D, Principal investigator, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341310
- Sponsor's protocol ID
- PN-III-P1-1.1-PD-2019-1191
- Acronym
- ADHDCoach
- Status last verified
- Oct 2024
- First submitted
- 11 Apr 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Clinic for Parents of Children With ADHD - an Individually-tailored Approach to Reduce Parental Distress
- ClinicalTrials.gov ID
- NCT05341310
- Acronym / sponsor ID
- ADHDCoach / PN-III-P1-1.1-PD-2019-1191
- Conditions
- ADHD
- Keywords
- Internet intervention, individually-tailored intervention, parental distress, ADHD, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 22 Apr 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHDCoach | Experimental | Behavioral: ADHDCoach, Other: Treatment as usualParticipants 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 | Active comparator | Other: Treatment as usualTreatment as usual at the outpatient clinic |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| ADHDCoachADHDCoach is an individually-tailored intervention to reduce parents' of children diagnosed with ADHD distress. | Behavioural | ADHDCoach |
| Treatment as usualTreatment as usual in the outpatient clinic | Other | ADHDCoach, Treatment as usual |
Primary outcome
Changes in parental psychological distress
Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
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.
6 secondary outcomes
Changes in child ADHD symptoms
Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Changes in parenting
Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Changes in parent-child closeness
Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
ADHD adult
Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Changes in ADHD Knowledge
Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Satisfaction with the intervention
Time frame: At 4 weeks after treatment initiation
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 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Costina R Păsărelu, Ph.D principal investigator
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHDCoach and Treatment as usual in people with ADHD, run by Babes-Bolyai University at 1 site in Romania.
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 3 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 18 Oct 2024. 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 Romania. 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?
Changes in parental psychological distress (time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination). 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 18 Oct 2024.