UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061847 |
|---|---|
| Receipt number | R000070771 |
| Scientific Title | A Group-Based Parent Training Program Integrating Behavioral Therapy, Acceptance and Commitment Therapy (ACT), and Peer Exchange for Parents of Adolescents with ADHD: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/09 14:39:41 |
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Basic information
Public title
Online Parent Training and Family Support Meeting for Parents of Adolescents with ADHD
Acronym
Adolescent ADHD Parent Training
Scientific Title
A Group-Based Parent Training Program Integrating Behavioral Therapy, Acceptance and Commitment Therapy (ACT), and Peer Exchange for Parents of Adolescents with ADHD: A Randomized Controlled Trial
Scientific Title:Acronym
Adolescent ADHD Parent Training
Region
| Japan |
Condition
Condition
adolescents with attention-deficit/hyperactivity disorder (ADHD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity that cause social and academic impairment. Behavioral parent training (BPT) teaches parents skills to manage children's challenging behaviors. Its efficacy for preschool- and school-aged children is supported by trials, meta-analyses, and guidelines, which recommend BPT alone or with pharmacotherapy.
Evidence for BPT for parents of adolescents with ADHD remains limited. Most BPT programs target children aged 12 years or younger, although adolescence involves distinct issues, including autonomy, oppositional attitudes, household rules, academic demands, smartphone use, money management, and peer relationships. Adolescent-specific BPT programs are therefore needed.
At our hospital, we adapted standard BPT components-praise, behavior classification, ABC analysis, effective instructions, environmental modification, and responses to inappropriate behavior-for adolescents. We added rewards other than praise, parent-child rule-setting, family meetings, rules for smartphones and money, and validation and motivation of the adolescent. We also incorporated acceptance and commitment therapy (ACT) exercises to support parents' psychological flexibility, stress management, values-based living, and mental health. ACT may improve parenting, parent-child relationships, and child behavior by helping parents accept difficult thoughts and emotions and act in line with their values.
This online program combines adolescent-tailored BPT, ACT-based exercises, and family support meetings for information exchange among families. By improving parents' skills and psychological flexibility, it is expected to enhance parent-child interactions and adolescents' adaptive behavior. This study will examine the effectiveness of this psychosocial intervention for adolescents with ADHD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conners-3 Global Index
The primary assessment time point will be T1, at 3-4 months, which will serve as the primary outcome.
As a secondary analysis, between-group differences at T2, at 6-7 months, will also be reported exploratorily.
Key secondary outcomes
Conners-3: Aggression, Inattention, Hyperactivity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will receive treatment as usual (TAU) plus an online parent training program for parents of adolescents with ADHD, consisting of behavioral parent training (BPT), acceptance and commitment therapy (ACT), and peer exchange among families.
The program will include three sessions, each about three hours including breaks, completed within three months, with about eight parents per course. Each session will include an introduction, homework review, lectures and exercises, summary, homework assignment, and a 30-minute peer exchange meeting.
Session 1 will cover basic BPT skills: praise, behavior classification, ABC analysis, clear instructions, and environmental modification. Homework will include practicing praise and classifying behaviors.
Session 2 will cover responses to undesirable behaviors, use of rewards, household rules, and family meetings. Parents will also learn to reduce the tendency to immediately correct the child and to use validation and motivation. Homework will include rule-setting, holding a family meeting, and using rewards.
Session 3 will cover applied BPT tools, including effort charts, self-monitoring, and written agreements. ACT exercises will include acceptance, defusion, mindfulness, parental values, and committed action. Homework will encourage continued skill use and values-based action.
In peer exchange meetings, confidentiality will be confirmed. Parents will speak in turn and share experiences, difficulties, and coping strategies. The first round will involve listening without comments; questions and discussion may follow. The aim is sharing, not criticism or evaluation.
Adherence will be assessed by session attendance and self-reported homework completion. The per-protocol population will be defined as participants attending at least two of the three sessions. Peer exchange attendance will be recorded but not included in fidelity assessment.
Interventions/Control_2
The control group will be a waitlist group and will continue to receive treatment as usual (TAU) only for three months after allocation. TAU may include medical consultations, pharmacotherapy, and psychosocial support as needed, based on the judgment of the attending physician. After completion of the primary assessment at T1, participants in the control group who wish to receive the intervention will be offered the same online parent training program as the intervention group for ethical reasons.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible children will be those in the period corresponding to junior high or high school age, defined as the period from the first April 1 after the day following their 12th birthday to the first March 31 after their 18th birthday. They must have been diagnosed with ADHD by their attending physician, using either DSM or ICD criteria. Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD) or learning disorder (LD), will be allowed to ensure external validity in real-world clinical settings. During the study period, the same parent or guardian must be able to complete assessment scales such as the Conners-3 and respond to online questionnaires, including having access to the necessary device and internet environment.
One parent or guardian per child will participate in the program, preferably the primary caregiver. The parent or guardian must be able to provide written informed consent based on the study explanation and must be able to understand and participate appropriately in the group program. This will be confirmed in advance by the attending physician or research staff.
Because this study aims to develop parent training specifically tailored to adolescence, the target age range will be limited to the junior high and high school period. Comorbidities such as ASD and LD will not be excluded, as they are common in ADHD and should be included for practical program development. For parents, the ability to understand and appropriately participate in the program is required to maintain group cohesion and the effectiveness of the intervention.
Key exclusion criteria
Children will be excluded if participation in a group intervention is judged inappropriate because of an acute psychotic state, severe risk of self-harm or harm to others, or similar clinical conditions. Children will also be excluded if the intervention effect is expected to be difficult to evaluate because of severe intellectual disability or other conditions, or if hospitalization is planned during the study period and continuation of the intervention or assessments is expected to be difficult.
Parents or guardians will be excluded if participation in the group program is difficult because of an acute psychotic state, severe cognitive impairment, or similar conditions. They will also be excluded if they have difficulty understanding explanations or completing questionnaires in Japanese, in order to ensure the validity of the assessment scales.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | YU |
| Middle name | |
| Last name | OGATA |
Organization
Stress Care Tokyo Ueno Ekimae Clinic
Division name
Department of Clinical Services
Zip code
110-0005
Address
6F Waseda Building, 7-7-7 Ueno, Taito-ku, Tokyo, Japan
TEL
0338427730
ogt.yuu@gmail.com
Public contact
Name of contact person
| 1st name | YU |
| Middle name | |
| Last name | OGATA |
Organization
Stress Care Tokyo Ueno Ekimae Clinic
Division name
Department of Clinical Services
Zip code
110-0005
Address
6F Waseda Building, 7-7-7 Ueno, Taito-ku, Tokyo, Japan
TEL
0338427730
Homepage URL
ogt.yuu@gmail.com
Sponsor or person
Institute
Stress Care Tokyo Ueno Ekimae Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute for Adolescent Developmental Research
Address
Stress Care Tokyo Ueno Ekimae Clinic
Tel
0338427730
stresscare.tokyo@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070771
