NCT06170996

Brief Summary

This study aims to investigate the effectiveness of an Internet-based behavioural parent training intervention on children's ADHD symptoms and children's and parents' mental health status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

December 6, 2023

Last Update Submit

July 17, 2024

Conditions

Keywords

Attention deficit hyperactivity disorder

Outcome Measures

Primary Outcomes (2)

  • Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)

    This questionnaire consists of two symptom domains: inattention (9 items) and hyperactivity/impulsivity (9 items). Each item of SNAP-IV assigned a score from 0 (never or rarely) to 3 (very often), with a higher score indicating more severe ADHD symptoms.

    From baseline to 2 months

  • Weiss Functional Impairment Scale-Parent form (WFIRS-P)

    This scale consists of 50 items, each with a score ranging from 0 to 3, a higher average score indicates a greater impairment.

    From baseline to 2 months

Secondary Outcomes (6)

  • Screen for Child Anxiety Related Emotional Disorders (SCARED)

    From baseline to 2 months

  • Children's Depression Inventory-Short Form (CDI-S)

    From baseline to 2 months

  • The seven-item version of the Generalized Anxiety Disorder (GAD-7)

    From baseline to 2 months

  • The nine-item version of the Patient Health Questionnaire (PHQ-9)

    From baseline to 2 months

  • Parenting Stress Index-Short Form (PSI-SF)

    From baseline to 2 months

  • +1 more secondary outcomes

Study Arms (2)

Internet-based behavioral parent training (I-BPT+RCC)

EXPERIMENTAL

Internet-based behavioural parent training in a group format in addition to routine clinical care, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.

Behavioral: Internet-based behavioral parent training (I-BPT)

Routine clinical care (RCC)

NO INTERVENTION

Routine clinical care for 2 months, delivered by experienced child psychiatrists, including medication treatment and examinations, crisis interventions, parent counselling and support.

Interventions

Internet-based behavioural parent training in a group format, 8 sessions over 2 months, delivered by a systematically trained and supervised therapist.

Internet-based behavioral parent training (I-BPT+RCC)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meeting the diagnostic criteria for ADHD in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
  • Total IQ greater than 70 as measured by the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV)
  • Child and their parents consent to the study

You may not qualify if:

  • Children or parents with severe organic encephalopathy and other severe mental disorders
  • Has received or is receiving behavioral treatment (parent training)
  • Parents who could not understand or lacking of access to computers and the Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Mental Health Centre

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Tang Jun, Master

    director in Child and Adolescent Psychological Ward of Wuhan Mental Health Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

March 12, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations