Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061847) titled 'Online Parent Training and Family Support Meeting for Parents of Adolescents with ADHD' on June 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Stress Care Tokyo Ueno Ekimae Clinic

Condition: Condition - adolescents with attention-deficit/hyperactivity disorder (ADHD) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 12 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 Size - 64

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070771

Disclaimer: Curated by HT Syndication.