Challenging BehaviorEarly Phase 1NCT07024303
Measurement of Treatment Effects
A Early Phase 1 study testing Psychotropic medication (at discretion of psychiatrist) and Behavioral therapy in people with Challenging Behavior and Autism Spectrum Disorder, run by Matthew J O'Brien, PhD, BCBA-D.
Trial summary
The overall objective is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that both behavioral treatment and medication will produce reductions in CB, but behavioral treatments, including behavior… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Challenging Behavior, Autism Spectrum Disorder
- What is being tested?
- Psychotropic medication (at discretion of psychiatrist) and Behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 31 Dec 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
The adult subjects will be the caregiver/guardian of the minor subjects. The only inclusion criterion for the adult subjects is that they must be the caregiver/legal guardian of the minor subject and their home is primarily English speaking.
The minor subjects will be individuals who were referred to Child and Adolescent Psychiatry at University of Iowa Healthcare for management of challenging behavior (e.g., physical aggression, self-injury, destruction, elopement, generalized refusal) and meet the following criteria:
- Between the ages of 2 years, 0 months and 12 years, 0 months
- Diagnosed with autism spectrum disorder
- Diagnosed with intellectual disability at the moderate, severe, or profound range (called "profound autism").
- Display challenging behavior, including one or more of the following: physical aggression, self-injury, destruction, elopement, generalized refusal
- Live in a home where English is the primary language spoken.
- The caregiver is considering medication, behavioral therapy, or both to treat the child's challenging behavior.
Subjects would be excluded if:
- Not diagnosed with autism spectrum disorder
- Do not have a moderate or severe/profound intellectual disability
- Do not display challenging behavior
- Live in a home where English is not the primary language spoken
- Caregivers are not considering medication, behavior therapy, or both to treat challenging behavior
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Measuring the Effects of Medication and Behavioral Treatments for Challenging Behavior
The overall objective is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that both behavioral treatment and medication will produce reductions in CB, but behavioral treatments, including behavior treatment + medication, will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior. We have four aims: Aim 1: Evaluate the concordance between indirect and direct measures of challenging behavior. We hypothesize that behavior change (% change) will be discordant between indirect and direct measurement data, regardless of treatment type, with direct measurement resulting in significantly greater change at each measurement timepoint. Aim 2: Compare the efficacy of psychotropic medication, behavior therapy, and combination therapy (medication+behavior therapy) on CB using indirect measures (ABC-I, BPI, CGI, MOSES) and direct observation (antecedent analysis). We hypothesize that all treatment modalities will reduce CB on both outcome measures at each standard timepoint, but behavioral therapy and combination therapy will produce a significantly greater reduction on direct observation of CB in the contexts most associated with challenging behavior. Aim 3: Compare the social validity of psychotropic medication, behavior therapy, and combination therapy using the Treatment Acceptability Rating Form-Revised (Reimers et al., 1992). Aim 4: Compare the social validity of measurement methods (indirect vs. direct).
Read the detailed description
Our overall objective of this study is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that behavioral treatment, medication, and combination treatment (medication+behavior therapy) will produce reductions in CB, but behavioral treatment and combination treatment will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior.
To address this objective, we plan to recruit up to 20 individuals under 13 years of age who are diagnosed with autism and exhibit challenging behavior to participate in this study. Subjects will be recruited from clinics where patients receive consultation on medication for challenging behavior. Subjects will be given the options of initiating/continuing medication, initiating behavior therapy, both medication and behavior therapy, or neither medication nor behavior therapy. The behavioral treatment provided as part of the research study will be functional communication training or FCT. FCT is a scientifically validated behavior therapy that involves teaching the child to use communication (in various forms) instead of challenging behavior to get what they want. It will be delivered at a timing (1 time per week) and dosage (60 minutes per visit) that is common for individuals with challenging behavior. Subjects will participate in a baseline behavioral assessment (baseline), as well as monthly behavioral assessments. Each behavioral assessment will include indirect (rating scales) and direct (antecedent analysis) measures of challenging behavior, as well as measures of social validity (treatment acceptability rating scales). Subjects will be followed for 6 months and comparisons of behavior change across measures will be used to determine treatment effectiveness and concordance between measures.
- Conditions
- Challenging Behavior, Autism Spectrum Disorder
- Being tested
- Psychotropic medication (at discretion of psychiatrist), Behavioral therapy
- Keywords
- psychotropic medication, behavioral therapy, behavioral measurement
- 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.
Psychotropic medication (at discretion of psychiatrist)Drug
The timing and dose of medication will be determined by the prescribing provider. Most medications are delivered daily and some medications may be delivered more than once per day. Providers are expected to adhere to professional guidelines for prescribing.
Behavioral therapyBehavioural
Functional communication training (FCT) will be delivered for 1 hour every week in-vivo or via telehealth. This timing and dosage has been shown effective in previous research. However, caregivers will be encouraged to practice the treatment procedures as often as possible on their own. Treatment will be delivered by a therapist and/or caregiver for those receiving in-vivo therapy and caregivers will deliver treatment with coaching from a therapist when using telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Psychotropic Medication | Experimental | Classes of psychotropic medications used as treatment for challenging behavior include antipsychotics (e.g., aripiprazole, quetiapine), stimulants (e.g., methylphenidate), alpha 2 agonists (e.g., clonidine), and mood-stabilizing anticonvulsants (e.g., valproate). However, other classes of psychotropics may be used to indirectly address challenging behavior (e.g., anxiolytics, antidepressants). Two medications (aripiprazole and risperidone) are FDA approved to treatment irritability for individuals with autism and challenging behavior. Psychotropic medications range in timing and dosage and their effects may be immediate (e.g., stimulants) or take as long as 6 weeks for full therapeutic effects (e.g., risperidone). Receives: Drug: Psychotropic medication (at discretion of psychiatrist) |
| Behavior Therapy | Experimental | In this study, FCT treatment will be provided weekly for approximately 60 min in duration. To facilitate communication during FCT, a word/picture card or microswitch (with recorded voice output) will be paired with any pre-existing child requests. Appropriate requests will be reinforced by the caregiver or therapist, and the occurrence of challenging behavior will be ignored (placed on extinction) or result in the caregiver/therapist providing guided compliance. An individualized FCT treatment plan will be developed based on the results of the functional analysis. For example, if the functional analysis identifies challenging behavior that functioned to escape task demands, then the FCT treatment plan will focus on teaching the child to request breaks appropriately after complying with instructions to complete a task. A typical task demand will be initiated by placing a small amount of developmentally appropriate "work" in front of the child and asking him or her to complete the task Receives: Behavioral: Behavioral therapy |
| Combined Treatment (Medication+Behavior Therapy) | Experimental | Participants in this arm will receive both medication and behavior therapy using the same manipulations as the Psychotropic Medication and Behavior Therapy Arms. Receives: Drug: Psychotropic medication (at discretion of psychiatrist); Behavioral: Behavioral therapy |
| No Treatment | No intervention | Participants who chose none of the treatment arms may participate in the assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist, Irritability Subscale
The ABC-I is a subscale of the 58-item ABC rating scale, which more broadly measures irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech (Aman et al., 1985). Items are rated on a 4-point. Likert scale from 0 to 3, with higher ratings corresponding to greater concern. Recent research has provided normative data for children with ASD, illustrating the validity of the five-factor structure and appropriate convergent and divergent validity (Kaat et al., 2014) as well as excellent internal consistency for the subscale of interest (Irritability = 0.92; Norris et al., 2019). The ABC-I consists of 15 items that measure child irritable mood and is commonly used to measure the effects of pharmacotherapy or behavioral therapy on disruptive behavior in children with autism (Bearss et al., 2015; Goel et al., 2018).
Measured: At enrollment and monthly for 12 months.
Behavior Problems Inventory
The BPI is a 52-item scale used to assess problem behavior in individuals with neurodevelopmental disabilities (Rojahn et al., 2001). Specific behaviors (e.g., hits others, bites self) are scored on a 5-point frequency scale (0 = never, 4 = hourly) and a 4-point severity scale (0 = no problem, 3 = severe problem). The BPI measures three types of behavior: self-injurious behaviors, stereotyped behavior, and aggressive or destructive behavior. The BPI has been determined to demonstrate reasonable validity and reliability (e.g., Rojahn et al., 2001).
Measured: At enrollment and monthly for 12 months.
Clinical Global Impressions Scale
The CGI is a comprehensive, clinician-determined summary measure that integrates all available information, including the patient's history, psychosocial context, symptoms, behavior, and the impact of symptoms on functional ability. The CGI consists of two single-item measures: (a) the severity of psychopathology, rated on a 1 to 7 scale, and (b) the change from the initiation of treatment, also rated on a seven-point scale. This measure is delivered following a clinical evaluation. The CGI has shown strong correlations with established research drug efficacy scales. The standard CGI is widely used in FDA-regulated trials.
Measured: At enrollment and every month for 12 months.
Home Situations Questionnaire
The HSQ-PDD is a 25-item scale used to assess behavioral compliance in everyday settings. It is typically completed by parents of individuals with ASD (Chowdhury et al., 2010). The HSQ-PDD is a modified version of the original HSQ (Barkley \& Edelbrock 1987) and includes additional items identified as relevant to children with ASD (e.g., when asked to move from one activity to another; when there is an unexpected change in routine). When completing the measure, the rater must first identify whether an item is a challenge for the child and then rate the severity of the problem on a 9-point Likert scale (1 = mild, 9 = severe). The HSQ-PDD consists of two factors (Socially Inflexible, 14 items; Demand-Specific, 6 items). Internal consistency for the scale as a whole is excellent (Chowdhury et al., 2010).
Measured: At enrollment and monthly for 12 months.
Monitoring of Side Effects Scale
The MOSES will be administered monthly and at the 6-month follow up to evaluate side effects from behavior therapy, medication, or both. The MOSES is a comprehensive caregiver/self-administered rating scale of the potential adverse effects from psychotropic medications. It includes 83 possible symptoms that may affect 8 areas of bodily functioning. It integrates self-report and observational methods. The MOSES was developed based on reviews of psychotropic medications. Items are scored based on a zero (not present) to 4 (severe) scoring system.
Measured: At enrollment and monthly for 12 months.
Treatment Acceptability Rating Form - Revised
The TARF-R will be administered monthly and at the 6-month follow up. It is a measure of social validity that is often used to evaluate behavioral therapies. The TARF-R consists of 20 items that are rated on a 7-point Likert-type scale: 17 items pertain to caregiver ratings of the total acceptability of the treatment, 2 items to caregiver perception of problem severity for the child, and 1 item to caregiver understanding of proposed intervention.
Measured: Monthly for 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Challenging BehaviorStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized (preference) parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew J O'Brien, PhD, BCBA-D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew J O'Brien, PhD, BCBA-D, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024303
- Sponsor's protocol ID
- 202411526
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 17 Jun 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 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effects of Medication and Behavioral Treatments for Challenging Behavior
- ClinicalTrials.gov ID
- NCT07024303
- Acronym / sponsor ID
- 202411526
- Conditions
- Challenging Behavior, Autism Spectrum Disorder
- Keywords
- psychotropic medication, behavioral therapy, behavioral measurement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Matthew J O'Brien, PhD, BCBA-DUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 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 overall objective is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that both behavioral treatment and medication will produce reductions in CB, but behavioral treatments, including behavior treatment + medication, will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior. We have four aims: Aim 1: Evaluate the concordance between indirect and direct measures of challenging behavior. We hypothesize that behavior change (% change) will be discordant between indirect and direct measurement data, regardless of treatment type, with direct measurement resulting in significantly greater change at each measurement timepoint. Aim 2: Compare the efficacy of psychotropic medication, behavior therapy, and combination therapy (medication+behavior therapy) on CB using indirect measures (ABC-I, BPI, CGI, MOSES) and direct observation (antecedent analysis). We hypothesize that all treatment modalities will reduce CB on both outcome measures at each standard timepoint, but behavioral therapy and combination therapy will produce a significantly greater reduction on direct observation of CB in the contexts most associated with challenging behavior. Aim 3: Compare the social validity of psychotropic medication, behavior therapy, and combination therapy using the Treatment Acceptability Rating Form-Revised (Reimers et al., 1992). Aim 4: Compare the social validity of measurement methods (indirect vs. direct).
Detailed description
Our overall objective of this study is to evaluate and compare the efficacy of two common treatments for CB in children and adolescents with autism using multiple outcome measures. Our central hypothesis is that behavioral treatment, medication, and combination treatment (medication+behavior therapy) will produce reductions in CB, but behavioral treatment and combination treatment will produce a greater reduction in CB when measured using direct observation within the contexts most associated with challenging behavior.
To address this objective, we plan to recruit up to 20 individuals under 13 years of age who are diagnosed with autism and exhibit challenging behavior to participate in this study. Subjects will be recruited from clinics where patients receive consultation on medication for challenging behavior. Subjects will be given the options of initiating/continuing medication, initiating behavior therapy, both medication and behavior therapy, or neither medication nor behavior therapy. The behavioral treatment provided as part of the research study will be functional communication training or FCT. FCT is a scientifically validated behavior therapy that involves teaching the child to use communication (in various forms) instead of challenging behavior to get what they want. It will be delivered at a timing (1 time per week) and dosage (60 minutes per visit) that is common for individuals with challenging behavior. Subjects will participate in a baseline behavioral assessment (baseline), as well as monthly behavioral assessments. Each behavioral assessment will include indirect (rating scales) and direct (antecedent analysis) measures of challenging behavior, as well as measures of social validity (treatment acceptability rating scales). Subjects will be followed for 6 months and comparisons of behavior change across measures will be used to determine treatment effectiveness and concordance between measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This is a non-randomized (preference) parallel group design
| Arm | Type | Receives |
|---|---|---|
| Psychotropic Medication | Experimental | Drug: Psychotropic medication (at discretion of psychiatrist)Classes of psychotropic medications used as treatment for challenging behavior include antipsychotics (e.g., aripiprazole, quetiapine), stimulants (e.g., methylphenidate), alpha 2 agonists (e.g., clonidine), and mood-stabilizing anticonvulsants (e.g., valproate). However, other classes of psychotropics may be used to indirectly address challenging behavior (e.g., anxiolytics, antidepressants). Two medications (aripiprazole and risperidone) are FDA approved to treatment irritability for individuals with autism and challenging behavior. Psychotropic medications range in timing and dosage and their effects may be immediate (e.g., stimulants) or take as long as 6 weeks for full therapeutic effects (e.g., risperidone). |
| Behavior Therapy | Experimental | Behavioral: Behavioral therapyIn this study, FCT treatment will be provided weekly for approximately 60 min in duration. To facilitate communication during FCT, a word/picture card or microswitch (with recorded voice output) will be paired with any pre-existing child requests. Appropriate requests will be reinforced by the caregiver or therapist, and the occurrence of challenging behavior will be ignored (placed on extinction) or result in the caregiver/therapist providing guided compliance. An individualized FCT treatment plan will be developed based on the results of the functional analysis. For example, if the functional analysis identifies challenging behavior that functioned to escape task demands, then the FCT treatment plan will focus on teaching the child to request breaks appropriately after complying with instructions to complete a task. A typical task demand will be initiated by placing a small amount of developmentally appropriate "work" in front of the child and asking him or her to complete the task |
| Combined Treatment (Medication+Behavior Therapy) | Experimental | Drug: Psychotropic medication (at discretion of psychiatrist), Behavioral: Behavioral therapyParticipants in this arm will receive both medication and behavior therapy using the same manipulations as the Psychotropic Medication and Behavior Therapy Arms. |
| No Treatment | No intervention | –Participants who chose none of the treatment arms may participate in the assessments. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Psychotropic medication (at discretion of psychiatrist)The timing and dose of medication will be determined by the prescribing provider. Most medications are delivered daily and some medications may be delivered more than once per day. Providers are expected to adhere to professional guidelines for prescribing. | Drug | Combined Treatment (Medication+Behavior Therapy), Psychotropic Medication |
| Behavioral therapyFunctional communication training (FCT) will be delivered for 1 hour every week in-vivo or via telehealth. This timing and dosage has been shown effective in previous research. However, caregivers will be encouraged to practice the treatment procedures as often as possible on their own. Treatment will be delivered by a therapist and/or caregiver for those receiving in-vivo therapy and caregivers will deliver treatment with coaching from a therapist when using telehealth. | Behavioural | Behavior Therapy, Combined Treatment (Medication+Behavior Therapy) |
Primary outcome
Aberrant Behavior Checklist, Irritability Subscale
Time frame: At enrollment and monthly for 12 months.
The ABC-I is a subscale of the 58-item ABC rating scale, which more broadly measures irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech (Aman et al., 1985). Items are rated on a 4-point. Likert scale from 0 to 3, with higher ratings corresponding to greater concern. Recent research has provided normative data for children with ASD, illustrating the validity of the five-factor structure and appropriate convergent and divergent validity (Kaat et al., 2014) as well as excellent internal consistency for the subscale of interest (Irritability = 0.92; Norris et al., 2019). The ABC-I consists of 15 items that measure child irritable mood and is commonly used to measure the effects of pharmacotherapy or behavioral therapy on disruptive behavior in children with autism (Bearss et al., 2015; Goel et al., 2018).
Behavior Problems Inventory
Time frame: At enrollment and monthly for 12 months.
The BPI is a 52-item scale used to assess problem behavior in individuals with neurodevelopmental disabilities (Rojahn et al., 2001). Specific behaviors (e.g., hits others, bites self) are scored on a 5-point frequency scale (0 = never, 4 = hourly) and a 4-point severity scale (0 = no problem, 3 = severe problem). The BPI measures three types of behavior: self-injurious behaviors, stereotyped behavior, and aggressive or destructive behavior. The BPI has been determined to demonstrate reasonable validity and reliability (e.g., Rojahn et al., 2001).
Clinical Global Impressions Scale
Time frame: At enrollment and every month for 12 months.
The CGI is a comprehensive, clinician-determined summary measure that integrates all available information, including the patient's history, psychosocial context, symptoms, behavior, and the impact of symptoms on functional ability. The CGI consists of two single-item measures: (a) the severity of psychopathology, rated on a 1 to 7 scale, and (b) the change from the initiation of treatment, also rated on a seven-point scale. This measure is delivered following a clinical evaluation. The CGI has shown strong correlations with established research drug efficacy scales. The standard CGI is widely used in FDA-regulated trials.
Home Situations Questionnaire
Time frame: At enrollment and monthly for 12 months.
The HSQ-PDD is a 25-item scale used to assess behavioral compliance in everyday settings. It is typically completed by parents of individuals with ASD (Chowdhury et al., 2010). The HSQ-PDD is a modified version of the original HSQ (Barkley \& Edelbrock 1987) and includes additional items identified as relevant to children with ASD (e.g., when asked to move from one activity to another; when there is an unexpected change in routine). When completing the measure, the rater must first identify whether an item is a challenge for the child and then rate the severity of the problem on a 9-point Likert scale (1 = mild, 9 = severe). The HSQ-PDD consists of two factors (Socially Inflexible, 14 items; Demand-Specific, 6 items). Internal consistency for the scale as a whole is excellent (Chowdhury et al., 2010).
Monitoring of Side Effects Scale
Time frame: At enrollment and monthly for 12 months.
The MOSES will be administered monthly and at the 6-month follow up to evaluate side effects from behavior therapy, medication, or both. The MOSES is a comprehensive caregiver/self-administered rating scale of the potential adverse effects from psychotropic medications. It includes 83 possible symptoms that may affect 8 areas of bodily functioning. It integrates self-report and observational methods. The MOSES was developed based on reviews of psychotropic medications. Items are scored based on a zero (not present) to 4 (severe) scoring system.
Treatment Acceptability Rating Form - Revised
Time frame: Monthly for 12 months.
The TARF-R will be administered monthly and at the 6-month follow up. It is a measure of social validity that is often used to evaluate behavioral therapies. The TARF-R consists of 20 items that are rated on a 7-point Likert-type scale: 17 items pertain to caregiver ratings of the total acceptability of the treatment, 2 items to caregiver perception of problem severity for the child, and 1 item to caregiver understanding of proposed 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 17 Jun 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psychotropic medication (at discretion of psychiatrist) and Behavioral therapy in people with Challenging Behavior and Autism Spectrum Disorder, run by Matthew J O'Brien, PhD, BCBA-D.
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: opening soon, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Matthew O'Brien, PHD ((309)373-3394, matthew-j-obrien@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist, Irritability Subscale (time frame: At enrollment and monthly for 12 months.). The study lists 6 primary outcomes in all. 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 17 Jun 2025.