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Completed

NCT Number: NCT05341310

An Internet-delivered Intervention for Parents of Children With ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ADHDCoach

Behavioral

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

Treatment as Usual

Other

Treatment as usual in the outpatient clinic

Primary outcomes

  1. 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

  1. Changes in child ADHD symptoms

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

    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.

  2. Changes in parenting

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

    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.

  3. Changes in parent-child closeness

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

    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.

  4. ADHD adult

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

    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.

  5. Changes in ADHD Knowledge

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

    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.

  6. Satisfaction with the intervention

    Time frame: At 4 weeks after treatment initiation

    Client Satisfaction Questionnaire-8. Scores range between 0 and 32, higher scores indicate higher satisfaction with the intervention.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

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

Acronym: ADHDCoach

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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