Clinical trial NCT05341310: An Internet-delivered Intervention for Parents of Children With ADHD
Official title: A Virtual Clinic for Parents of Children With ADHD - an Individually-tailored Approach to Reduce Parental Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: Internet intervention
individually-tailored intervention
parental distress
ADHD
children
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Changes in parental psychological distress
timeFrame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
Secondary outcomes:
measure: Changes in child ADHD symptoms
timeFrame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
measure: Changes in parenting
timeFrame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
measure: Changes in parent-child closeness
timeFrame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
measure: ADHD adult
timeFrame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
measure: Changes in ADHD Knowledge
timeFrame: Baseline, 4 weeks and follow-up at 3 months after treatment termination
measure: Satisfaction with the intervention
timeFrame: At 4 weeks after treatment initiation
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
affiliation: Babes-Bolyai University
name: Costina R Păsărelu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: