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CompletedNCT05341310ADHDCoachUpdated Oct 18, 2024

An Internet-delivered Intervention for Parents of Children With ADHD

An interventional study of ADHDCoach and Treatment as usual in ADHD, sponsored by Babes-Bolyai University. Completed at 1 site in Romania. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • ADHD

Keywords

  • Internet intervention
  • individually-tailored intervention
  • parental distress
  • ADHD
  • children
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 86 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Babes-Bolyai University is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    ADHDCoach

    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.

    Behavioral: ADHDCoach · Other: Treatment as usual

  • Active comparator
    Treatment as usual

    Treatment as usual at the outpatient clinic

    Other: Treatment as usual

Interventions

  • BehavioralADHDCoach

    ADHDCoach is an individually-tailored intervention to reduce parents' of children diagnosed with ADHD distress.

  • OtherTreatment as usual

    Treatment as usual in the outpatient clinic

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination

Secondary outcomes

  1. 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.

    Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination

  2. 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.

    Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination

  3. 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.

    Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination

  4. 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.

    Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination

  5. 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.

    Time frame: Baseline, 4 weeks and follow-up at 3 months after treatment termination

  6. Satisfaction with the intervention

    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

07

Study locations

1 site
  • Babes-Bolyai University
    Cluj-Napoca, 400015, Romania
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05341310
Lead sponsor
Babes-Bolyai University
Responsible party
Costina-Ruxandra Poetar (Assistant professor, Babes-Bolyai University) — Principal investigator
First posted
Apr 22, 2022
Start date
Mar 1, 2022
Primary completion
Dec 20, 2023
Completion
Mar 30, 2024
Last update
Oct 18, 2024

Study contacts

Costina R Păsărelu, Ph.D
principal investigator · Babes-Bolyai University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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