An Internet-delivered Intervention for Parents of Children With ADHD

NCT05341310 | Completed

• 1 other identifier: PN-III-P1-1.1-PD-2019-1191
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Internet intervention; individually-tailored intervention; parental distress; ADHD; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

ADHDCoach

EXPERIMENTAL

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; Other: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual at the outpatient clinic

Other: Treatment as usual

Interventions

ADHDCoach BEHAVIORAL

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

ADHDCoach

Treatment as usual OTHER

Treatment as usual in the outpatient clinic

ADHDCoach; Treatment as usual

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Costina R Păsărelu, Ph.D

  Babes-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: March 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: March 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)