Parenting with an Autism Spectrum Disorder

March 6, 2025 updated by: Johannes Boettcher, Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parents who fulfill the main diagnosis of ASD, who are ≥ 18 years old and have a child aged 0 to 6 years.

Description

In- and exclusion criteria for the study population:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Above-mentioned psychiatric diagnoses
  • Below-average general cognitive ability
  • Lack of German language skills
  • Severe impairment of vision or hearing (not corrected)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Autistic Traits
Time Frame: Baseline assessment
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.
Baseline assessment
Parental Quality of Life
Time Frame: Baseline assessment
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.
Baseline assessment
Parental mental health
Time Frame: Baseline assessment
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.
Baseline assessment
Children mental health
Time Frame: Baseline assessment
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.
Baseline assessment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotion regulation
Time Frame: Baseline assessment
The Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) is an 18-item questionnaire designed to assess emotion regulation difficulties in adults. The measurement covers four dimensions of emotion regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to perceived effective emotion regulation strategies. Scores for the DERS-SF range from 18 to 90, with higher scores indicating greater difficulties in emotion regulation.
Baseline assessment
Parental stress
Time Frame: Baseline assessment
The Parental Stress Inventory (Eltern-Belastungs-Inventar; EBI) is an instrument for assessing parental stress. The Parental Stress Inventory comprises a total of 48 items. It provides indications of whether parents are impaired in their tasks of parenting, caring, and providing for their child due to increased stress, thus necessitating support or intervention measures for the family. Scores for the Parental Stress Inventory range from 48 to 240, with higher scores indicating greater parental stress.
Baseline assessment
Self-efficacy in parenting
Time Frame: Baseline assessment
The Parenting Self-Efficacy Questionnaire (Fragebogen zur Selbstwirksamkeit in der Erziehung; FSW) is a 9-item questionnaire designed to assess parenting self-efficacy. Scores for the Parenting Self-Efficacy Questionnaire range from 9 to 45, with higher scores indicating greater self-efficacy in parenting.
Baseline assessment
Mentalization II
Time Frame: Baseline assessment
The Certainty About Mental States Questionnaire (CAMSQ) is a self-assessment instrument for measuring the perceived ability to understand mental states of oneself and others (i.e., mentalizing). The CAMSQ consists of 20 items answered on a seven-point response scale. Scores for the Certainty About Mental States Questionnaire range from 20 to 140, with higher scores indicating a greater perceived ability to understand mental states.
Baseline assessment
Mentalization III
Time Frame: Baseline assessment
The Parental Reflective Functioning Questionnaire (PRFQ) will be used to assess Parental Reflective Functioning (PRF) as a multidimensional construct. The PRFQ consists of 18 items rated on a 7-point Likert scale. Scores for the Parental Reflective Functioning Questionnaire range from 18 to 126, with higher scores indicating greater parental reflective functioning.
Baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LPEK-0765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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