An Internet-delivered Intervention for Parents of Children With ADHD

ADHD Clinical Trial

— ADHDCoach  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05341310
• Other study ID #: PN-III-P1-1.1-PD-2019-1191
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

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

Other:
• Treatment as usual
Treatment as usual in the outpatient clinic

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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