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Clinical Trials/NCT05341310
NCT05341310
Completed
Not Applicable

A Virtual Clinic for Parents of Children With ADHD - an Individually-tailored Approach to Reduce Parental Distress

Babes-Bolyai University1 site in 1 country86 target enrollmentMarch 1, 2022
ConditionsADHD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
Babes-Bolyai University
Enrollment
86
Locations
1
Primary Endpoint
Changes in parental psychological distress
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
March 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Babes-Bolyai University
Responsible Party
Principal Investigator
Principal Investigator

Costina-Ruxandra Poetar

Assistant professor

Babes-Bolyai University

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in child ADHD symptoms(Baseline, 4 weeks and follow-up at 3 months after treatment termination)
  • Changes in parenting(Baseline, 4 weeks and follow-up at 3 months after treatment termination)
  • Changes in parent-child closeness(Baseline, 4 weeks and follow-up at 3 months after treatment termination)
  • ADHD adult(Baseline, 4 weeks and follow-up at 3 months after treatment termination)
  • Changes in ADHD Knowledge(Baseline, 4 weeks and follow-up at 3 months after treatment termination)
  • Satisfaction with the intervention(At 4 weeks after treatment initiation)

Study Sites (1)

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