Autism Spectrum DisorderNCT06502054
Parenting with an Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
In many individuals, Autism Spectrum Disorder (ASD) is recognized and diagnosed late in adolescence or even in adulthood, despite the presence of long-standing impairments and distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 184 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to Oct 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents who fulfill the main diagnosis of ASD, who are ≥ 18 years old and have a child aged 0 to 6 years.
Who may be able to join
- Parents who fulfill the main diagnosis of ASD, including atypical autism (ICD-10: F84.1) and Asperger syndrome (ICD-10: F84.5)
- Age ≥ 18 years
- Have a child aged 0 to 6 years
- Parents without a lifetime main diagnosis of a psychiatric illness (ICD-10-GM-2016: F10 - F69)
- Age ≥ 18 years
- Have a child aged 0 to 6 years
- Matched to the study group in terms of age and gender
Who cannot join
- Below-average general cognitive ability (according to clinical impression)
- Lack of German language skills
- Severe visual or hearing impairment (uncorrected)
- Serious neurological and psychiatric illnesses (e.g., epilepsy, psychoses)
- Acute suicidal tendencies (according to clinical findings)
- Eligibility Criteria for the Control Group
Show all 10Show fewer
- Above-mentioned psychiatric diagnoses
- Below-average general cognitive ability
- Lack of German language skills
- Severe impairment of vision or hearing (not corrected)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Holger Zapf, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Johannes Dr. Boettcher, +49 152 22832379, j.boettcher@uke.de
About this study
Official title: Being a Parent with an Autism Spectrum Disorder: Strengths, Challenges and Adaptation of a Mentalization-based Parenting Program
In many individuals, Autism Spectrum Disorder (ASD) is recognized and diagnosed late in adolescence or even in adulthood, despite the presence of long-standing impairments and distress. One area that has received little attention so far is research and interventions in clinical practice that relate to the experienced realities of parenthood for autistic adults or offer support in this context. The few existing research findings in this field suggest that parents with ASD might face specific challenges. At the same time, there is a lack of empirical research on the experiences autistic adults have with parenthood, whether they perceive a need for specific support services, and, if so, what those services should look like. To fill this research gap, this study aims to examine the mental health, needs, and strengths of parents with ASD. Particular focus will be given to parental stress and difficulties in the areas of mentalization and emotion regulation, which can increase the risk of psychological comorbidities. Using a mixed-methods approach, the study will investigate to what extent an already established parenting program or an adaptation thereof might be suitable to address the specific requirements of autistic parents and enhance their parenting skills.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Parenthood, Autism Spectrum Disorder, Preschool children
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autistic parents | Parents who fulfill the main diagnosis of ASD, which includes atypical autism (ICD-10: F84.1) and Asperger syndrome (ICD-10: F84.5), who are ≥ 18 years old and have a child aged 0 to 6 years are included. | |
| Non-autistic parents | Parents are included who do not have a lifetime main diagnosis of a psychiatric illness (ICD-10-GM-2016: F10 - F69), who are ≥ 18 years old and have a child aged 0 to 6 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mentalization
The Mentalization Scale (MentS) is a 28-item instrument for measuring mentalization in three aspects: self-related, other-related, and motivation to mentalize. The total score for the MentS ranges from 28 to 140, with higher scores indicating a higher overall ability to mentalize. Higher scores in the subscales and total score indicate a higher ability to mentalize.
Measured: Baseline assessment
Secondary outcomes (4)
Autistic Traits
The Autism Spectrum Quotient-10 (AQ-10) is a shortened self-report questionnaire developed to measure autistic traits in adults. The instrument is a brief version of the Autism Spectrum Quotient and consists of 10 items that can be used as a screening tool. The total score for the Autism Spectrum Quotient-10 ranges from 0 to 10, with higher scores indicating a higher presence of autistic traits.
Measured: Baseline assessment
Parental Quality of Life
The Short-Form Health Survey - 12 (SF-12) is a screening instrument for assessing health-related quality of life. The SF-12 includes the Physical Component Summary score representing General Health Perception, Physical Functioning, Role Physical, and Bodily Pain, and the Mental Component Summary score reflecting Emotional Role Functioning, Mental Health, Vitality, and Social Functioning. Scores for the SF-12 typically range from 0 to 100 for each summary component, with higher scores indicating better health-related quality of life.
Measured: Baseline assessment
Parental mental health
The Brief Symptom Inventory-18 (BSI-18) is a shortened version of the Symptom Checklist 90, consisting of 18 items. The BSI-18 short form is a cost-effective, reliable, and valid self-report measure that is increasingly internationally recognized. It comprises 6 items each assessing the syndromes of somatization, depression, and anxiety. Scores for the BSI-18 range from 0 to 72, with higher scores indicating greater symptom severity.
Measured: Baseline assessment
Children mental health
The Strengths and Difficulties Questionnaire (SDQ) is one of the most commonly used measures for assessing the mental health of children and adolescents from both self and parent perspectives. The SDQ assesses mental health issues and resources in children and adolescents aged 2 to 17 years with five items each across five subscales: conduct problems, emotional symptoms, hyperactivity, peer problems, and prosocial behavior. Scores for each subscale range from 0 to 10, and the total difficulties score ranges from 0 to 40. Higher scores on the conduct problems, emotional symptoms, hyperactivity, and peer problems subscales indicate greater difficulties, while higher scores on the prosocial behavior subscale indicate greater strengths.
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Sep 2024
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 184 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502054
- Sponsor's protocol ID
- LPEK-0765
- Status last verified
- Mar 2025
- First submitted
- 5 Jul 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Being a Parent with an Autism Spectrum Disorder: Strengths, Challenges and Adaptation of a Mentalization-based Parenting Program
- ClinicalTrials.gov ID
- NCT06502054
- Acronym / sponsor ID
- LPEK-0765
- Conditions
- Autism Spectrum Disorder
- Keywords
- Parenthood, Autism Spectrum Disorder, Preschool children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Jul 2024 (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.
In many individuals, Autism Spectrum Disorder (ASD) is recognized and diagnosed late in adolescence or even in adulthood, despite the presence of long-standing impairments and distress. One area that has received little attention so far is research and interventions in clinical practice that relate to the experienced realities of parenthood for autistic adults or offer support in this context. The few existing research findings in this field suggest that parents with ASD might face specific challenges. At the same time, there is a lack of empirical research on the experiences autistic adults have with parenthood, whether they perceive a need for specific support services, and, if so, what those services should look like. To fill this research gap, this study aims to examine the mental health, needs, and strengths of parents with ASD. Particular focus will be given to parental stress and difficulties in the areas of mentalization and emotion regulation, which can increase the risk of psychological comorbidities. Using a mixed-methods approach, the study will investigate to what extent an already established parenting program or an adaptation thereof might be suitable to address the specific requirements of autistic parents and enhance their parenting skills.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autistic parents | – | –Parents who fulfill the main diagnosis of ASD, which includes atypical autism (ICD-10: F84.1) and Asperger syndrome (ICD-10: F84.5), who are ≥ 18 years old and have a child aged 0 to 6 years are included. |
| Non-autistic parents | – | –Parents are included who do not have a lifetime main diagnosis of a psychiatric illness (ICD-10-GM-2016: F10 - F69), who are ≥ 18 years old and have a child aged 0 to 6 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents who fulfill the main diagnosis of ASD, who are ≥ 18 years old and have a child aged 0 to 6 years.
Key inclusion criteria (7 listed)
- Parents who fulfill the main diagnosis of ASD, including atypical autism (ICD-10: F84.1) and Asperger syndrome (ICD-10: F84.5)
- Age ≥ 18 years
- Have a child aged 0 to 6 years
- Parents without a lifetime main diagnosis of a psychiatric illness (ICD-10-GM-2016: F10 - F69)
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Below-average general cognitive ability (according to clinical impression)
- Lack of German language skills
- Severe visual or hearing impairment (uncorrected)
- Serious neurological and psychiatric illnesses (e.g., epilepsy, psychoses)
- Acute suicidal tendencies (according to clinical findings)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mentalization
Time frame: Baseline assessment
The Mentalization Scale (MentS) is a 28-item instrument for measuring mentalization in three aspects: self-related, other-related, and motivation to mentalize. The total score for the MentS ranges from 28 to 140, with higher scores indicating a higher overall ability to mentalize. Higher scores in the subscales and total score indicate a higher ability to mentalize.
4 secondary outcomes
Autistic Traits
Time frame: Baseline assessment
Parental Quality of Life
Time frame: Baseline assessment
Parental mental health
Time frame: Baseline assessment
Children mental health
Time frame: Baseline assessment
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 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
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.
Holger Zapf, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, 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?
The sponsor lists 7 inclusion and 10 exclusion criteria. 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 11 Mar 2025. 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.
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?
Mentalization (time frame: Baseline assessment). 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 11 Mar 2025.