An Internet-delivered Intervention for Parents of Children With ADHD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: ADHDCoach
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADHDCoach<br>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<br>* ADHDCoach is an individually-tailored intervention to reduce parents' of children diagnosed with ADHD distress.<br>Other: Treatment as usual<br>* Treatment as usual in the outpatient clinic<br>|
| Active Comparator: Treatment as usual<br>Treatment as usual at the outpatient clinic | Other: Treatment as usual<br>* Treatment as usual in the outpatient clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 4 weeks and follow-up at 3 months after treatment termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | At 4 weeks after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet intervention, individually-tailored intervention, parental distress, ADHD, children