Study GroupEarly Phase 1HEARTNCT07009522
Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)
A Early Phase 1 study testing Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART in people with Study Group, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The study focuses on a group training program called HEART aimed at helping adolescents with Autism Spectrum Disorder improve emotional regulation. It will use a pilot trial to evaluate the program's feasibility and effectiveness. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Study Group
- What is being tested?
- Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2026to 15 Feb 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Autistic adolescents will be included in the study, recruited from various departments of the Clinic for Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics at UKE, as well as from autism therapy centers. Eligible participants are adolescents aged 13 to 18 years who meet the criteria for a primary diagnosis of an autism spectrum disorder-including early childhood autism (ICD-10: F84.0), atypical autism (ICD-10: F84.1), and Asperger's syndrome (ICD-10: F84.5)-and who have sufficient knowledge of the German language. The diagnosis should be confirmed based on developmental history, the ADOS-2 assessment, and a clinical diagnosis from a specialized clinician. Additionally, only autistic adolescents exhibiting difficulties in emotion regulation (measured by the Emotion Regulation Inventory (EDI-SF), T-score ≥ 60) will be included. Exclusion criteria are: below-average cognitive abilities, IQ ≤ 85 (ICD-10: F70); lack of German language skills; or significant visual or hearing impairments that cannot be corrected. Furthermore, patients with severe neurological or psychiatric conditions (e.g., epilepsy, syndromic disorders with neuropsychiatric involvement, psychoses) or current acute suicidality, as assessed clinically, will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Johannes Boettcher, Dr., +49 152 22832379, j.boettcher@uke.de
About this study
The study focuses on a group training program called HEART aimed at helping adolescents with Autism Spectrum Disorder improve emotional regulation. It will use a pilot trial to evaluate the program's feasibility and effectiveness. The findings aim to advance scientific understanding and support the development of effective, evidence-based interventions to strengthen psychosocial support for autistic adolescents.
Read the detailed description
Adolescents with Autism Spectrum Disorder (ASD) often experience significant difficulties in emotional regulation due to increasing developmental challenges, which can lead to a higher prevalence of psychological comorbidities such as anxiety disorders and depression. Despite the urgent need for specific therapeutic interventions, this area remains largely underrepresented in clinical practice and research. The present study aims to address this gap by investigating the feasibility and effectiveness of the behavioral therapy program "Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART). A pilot trial will be used to evaluate the feasibility and acceptability of the intervention. The intervention group will participate in a group training adapted to the needs of adolescents with ASD. This pilot study could significantly contribute to the scientific understanding of emotion regulation in adolescents with ASD and support the development of practically relevant evidence-based interventions. The study's findings could have important implications for clinical practice. The group training is based on proven behavioral therapy methods established among therapists in Germany. The manualized manual for the adapted application of these methods with autistic adolescents could thus serve as a foundation for improving psychosocial care for this target group.
- Conditions
- Study Group
- Being tested
- Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEARTBehavioural
The group program for adolescents with ASD takes place weekly. Each session lasts 100 minutes (including a break), and the training includes a total of 12 sessions. The intervention is manualized and is based on the theoretical foundations of Cognitive Behavioral Therapy, Mindfulness-Based Therapy, and the TEACCH approach (Mesibov et al., 2005). Parallel to the adolescents, their parents will participate in a separate group training, which will be conducted in five sessions of 100 minutes each and is closely linked in content to the adolescent group training.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | study group Receives: Behavioral: Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Dysregulation
The Emotion Dysregulation Inventory - Short Form (EDI-SF, Mazefsky, Day, et al., 2018; Mazefsky, Yu, et al., 2018) is a 13-item questionnaire designed to assess emotion regulation problems in children and adolescents through self-report and parent-report. The items are answered on a five-point Likert scale, ranging from 1 = "not at all" to 5 = "very severe." The questionnaire evaluates two scales: "Reactivity" and "Dysphoria." Higher scores indicate greater emotional dysregulation. The primary outcome criterion is emotion regulation, which will be assessed from the parent perspective using the EDI-SF.
Measured: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention.
Secondary outcomes (6)
Autistic Traits
The Social Responsiveness Scale (SRS-16; Constantino et al., 2003) is a quantitative measure of autistic traits in children, adolescents, and adults. The SRS-16 (Sturm et al., 2017) is a 16-item parent questionnaire designed to assess social, communicative, and rigid behaviors in children and adolescents for dimensional autism diagnostics. The items are answered on a four-point response scale, ranging from 1 = "not at all" to 4 = "almost always." A total score is calculated by summing the items. The total score ranges from 16 to 80, with higher values indicating greater severity of impairment. The SRS has demonstrated good psychometric properties and cross-cultural validity for the assessment of ASD (Bölte et al., 2008, 2011).
Measured: Lead-in period" (6 weeks before randomization; T0)
Quality of Life and psychological well-being
The KIDSCREEN-10 (Ravens-Sieberer et al., 2010) is a brief, standardized instrument for assessing the quality of life and psychological well-being of children and adolescents aged 8 to 18 years from self-report and parent perspective. The KIDSCREEN-10 includes a total of 10 items focusing on various dimensions of quality of life, including emotional well-being, social well-being, physical health, and joy of life. The items are answered on a five-point response scale, ranging from 1 = "not at all true" to 5 = "completely true." The questionnaire is characterized by good psychometric validity and reliability and is suitable for use across different populations (Ravens-Sieberer et al., 2010).
Measured: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Self-perceived depressive symptoms
The Beck Depression Inventory for Youth - Second Edition (BDI-Y-2; Beck et al., 2001) is a self-report questionnaire designed to assess the severity of depressive disorder in children and adolescents aged 7 to 18 years. For adults aged 18 and above, the Beck Depression Inventory-II (BDI-II) is used. The 20 items measure negative thoughts of the child or adolescent about themselves, their life, and the future, as well as feelings of sadness and physiological symptoms of depression, based on the diagnostic criteria of DSM-5. The German version of the instrument demonstrates acceptable psychometric properties (Beck et al., 2001; Siefen \& Busch, 2018).
Measured: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Self-perceived anxiety symptoms
The Beck Anxiety Inventory for Youth - Second Edition (BAI-Y-2; Beck et al., 2001) is a self-report questionnaire designed to assess the severity of anxiety in children and adolescents aged 7 to 18 years. For adults aged 18 and above, the Beck Anxiety Inventory (BAI) is used. The 20 items assess specific and generalized anxieties, including fears related to school, fear of injury, and health-related anxieties. Additionally, the inventory captures various symptoms of anxiety, such as rumination and worry-driven thoughts, as well as physiological symptoms, based on the diagnostic criteria of DSM-5. The German version of the instrument demonstrates acceptable psychometric properties (Beck et al., 2001; Siefen \& Busch, 2018).
Measured: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Quality of Parent-Adolescent Communication
The Parent-Adolescent Communication Scale (PACS; Barnes \& Olson, 1982) is a questionnaire used to assess the quality of dyadic parent-child communication between parents and adolescents. The PACS is available for self-report and third-party assessment and includes the subscales "Open Communication" and "Communication Problems." The short version of the instrument contains 6 items, which are answered on a five-point response scale from 1 = "strongly disagree" to 5 = "strongly agree." The problematic items are recoded afterward. The sum of the items is calculated to obtain a total score, which ranges from 6 to 30, with higher scores indicating better quality of parent-child communication. The German version of the PACS demonstrates good psychometric properties (Zapf \& Boettcher, 2024).
Measured: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Patient satisfaction
The Questionnaire for Patient Satisfaction (ZUF-8; Schmidt et al., 1989) is an instrument used to assess overall patient satisfaction at the end of an intervention. The ZUF-8 comprises eight items, which are answered on a four-point Likert scale. The total score is calculated by summing the items, resulting in a score ranging from 8 to 32, with higher values indicating greater patient satisfaction. There are both an adult version for parents and a child version. The ZUF-8 demonstrates good psychometric properties (Kriz et al., 2008).
Measured: (T4) after the completion of the 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 Jan 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study GroupStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study design is group-based intervention with a one-arm design.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Boettcher, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Johannes Boettcher, Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009522
- Sponsor's protocol ID
- LPEK-0914
- Other IDs
- 04/107
- Acronym
- HEART
- Status last verified
- Jul 2026
- First submitted
- 29 May 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)
- ClinicalTrials.gov ID
- NCT07009522
- Acronym / sponsor ID
- HEART / LPEK-0914
- Conditions
- Study Group
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study focuses on a group training program called HEART aimed at helping adolescents with Autism Spectrum Disorder improve emotional regulation. It will use a pilot trial to evaluate the program's feasibility and effectiveness. The findings aim to advance scientific understanding and support the development of effective, evidence-based interventions to strengthen psychosocial support for autistic adolescents.
Detailed description
Adolescents with Autism Spectrum Disorder (ASD) often experience significant difficulties in emotional regulation due to increasing developmental challenges, which can lead to a higher prevalence of psychological comorbidities such as anxiety disorders and depression. Despite the urgent need for specific therapeutic interventions, this area remains largely underrepresented in clinical practice and research. The present study aims to address this gap by investigating the feasibility and effectiveness of the behavioral therapy program "Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART). A pilot trial will be used to evaluate the feasibility and acceptability of the intervention. The intervention group will participate in a group training adapted to the needs of adolescents with ASD. This pilot study could significantly contribute to the scientific understanding of emotion regulation in adolescents with ASD and support the development of practically relevant evidence-based interventions. The study's findings could have important implications for clinical practice. The group training is based on proven behavioral therapy methods established among therapists in Germany. The manualized manual for the adapted application of these methods with autistic adolescents could thus serve as a foundation for improving psychosocial care for this target group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is group-based intervention with a one-arm design.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEARTstudy group |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEARTThe group program for adolescents with ASD takes place weekly. Each session lasts 100 minutes (including a break), and the training includes a total of 12 sessions. The intervention is manualized and is based on the theoretical foundations of Cognitive Behavioral Therapy, Mindfulness-Based Therapy, and the TEACCH approach (Mesibov et al., 2005). Parallel to the adolescents, their parents will participate in a separate group training, which will be conducted in five sessions of 100 minutes each and is closely linked in content to the adolescent group training. | Behavioural | Study group |
Primary outcome
Emotion Dysregulation
Time frame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention.
The Emotion Dysregulation Inventory - Short Form (EDI-SF, Mazefsky, Day, et al., 2018; Mazefsky, Yu, et al., 2018) is a 13-item questionnaire designed to assess emotion regulation problems in children and adolescents through self-report and parent-report. The items are answered on a five-point Likert scale, ranging from 1 = "not at all" to 5 = "very severe." The questionnaire evaluates two scales: "Reactivity" and "Dysphoria." Higher scores indicate greater emotional dysregulation. The primary outcome criterion is emotion regulation, which will be assessed from the parent perspective using the EDI-SF.
6 secondary outcomes
Autistic Traits
Time frame: Lead-in period" (6 weeks before randomization; T0)
Quality of Life and psychological well-being
Time frame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Self-perceived depressive symptoms
Time frame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Self-perceived anxiety symptoms
Time frame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Quality of Parent-Adolescent Communication
Time frame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
Patient satisfaction
Time frame: (T4) after the completion of the 3-month intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Boettcher, Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART in people with Study Group, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Boettcher, Dr. (+49 152 22832379, j.boettcher@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Dysregulation (time frame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.