Autism Spectrum DisorderNCT05803369
DOD Regulating Together Intervention
A study testing Regulating Together (RT) and Achieving Independence and Mastery in School (AIMS) in people with Autism Spectrum Disorder and Emotion Regulation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Emotion Regulation
- What is being tested?
- Regulating Together (RT) and Achieving Independence and Mastery in School (AIMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of autism spectrum disorder (ASD)
- A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test
- Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R).
- Caregivers and child are fluent in speaking English
- Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3.
- Family willing to keep prescribed medication and outside interventions stable
- willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS).
- The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate.
Who cannot join
- Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.
- any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches.
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)
Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.
Read the detailed description
144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS) groups. Participants will complete assessments at five time points: Screen (T1) Week 0 - where they will complete consent; Baseline (T2); Week 7: Post Active Treatment (includes semi-structured interviews) (T3); Week 16: Post Generalization (T4); Week 29: Final outcome visit (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
- Conditions
- Autism Spectrum Disorder, Emotion Regulation
- Being tested
- Regulating Together (RT), Achieving Independence and Mastery in School (AIMS)
- Keywords
- Regulating Together
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulating Together (RT)Behavioural
Regulating Together is an intensive outpatient group treatment targeting emotion dysregulation. It engages both caregivers and children and utilizes evidence-based intervention techniques including cognitive behavioral therapy (CBT), visuals, reinforcements, and scaffolding, and newer interventions such as mindfulness and acceptance-based therapy.
Achieving Independence and Mastery in School (AIMS)Behavioural
AIMS is a school-based program developed to help students with social-communication challenges (such as autism spectrum disorder) achieve academic success. It is well-established and has been used with autistic youth, both in schools and in outpatient settings.
| Study group | Role | What they receive |
|---|---|---|
| Regulating Together (RT) | Experimental | Participants will receive Regulating Together -the emotion dysregulation intervention Receives: Behavioral: Regulating Together (RT) |
| Achieving Independence and Mastery in School (AIMS) | Active comparator | Participants will receive AIMS, the academic functioning/organizational skill intervention. Receives: Behavioral: Achieving Independence and Mastery in School (AIMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Dysregulation Inventory- Reactivity
13-item parent report measure that captures negative emotional responses and Dysphoria characterized by increased negative affect and lack of motivation. Higher scores mean higher emotional reactivity.
Measured: Through study completion, about 29 weeks
Secondary outcomes (3)
Children's Organizational Skills Scale (COSS)
Used to measure outcomes from AIMS intervention. It is a rating scale completed by parents and teachers which yields three factors measuring Organized Actions, Task Planning, and Memory and Materials Management. Higher scores mean higher organizational skills.
Measured: Through study completion, about 29 weeks
Daily Phone Diary
Phone interview administered by staff that documents Frequency and Intensity of Behavioral and Emotional Outbursts over a 2 day period.
Measured: Through study completion, about 29 weeks
Inpatient Hospitalization Rates
chart review and caregiver report for any psychiatric hospitalizations
Measured: during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Aug 2022
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Rebecca Shaffer, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803369
- Sponsor's protocol ID
- W81XWH-22-1-0168
- Other IDs
- CDMRP-AR210169
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kang S, Burkett K, Sarawgi S, Ruberg J, Paustian J, Reisinger DL, Schmitt LM, Shaffer RC. Regulating Together: Caregivers' experiences in a shared journey through an emotion dysregulation intervention for autistic youth. Res Dev Disabil. 2026 Jul;174:105317. doi: 10.1016/j.ridd.2026.105317. Epub 2026 May 31.
PubMed 42217453McKinney WS, Tadevich LJ, Schmitt LM, Horn PS, Ruberg JR, White SW, Reisinger DL, Burkett KW, Sarawgi S, Kang S, Shaffer RC. Study protocol for a randomized controlled trial of Regulating Together (RT), a group therapy for emotion dysregulation in school-age autistic youth and their caregivers. BMC Psychol. 2025 Apr 24;13(1):436. doi: 10.1186/s40359-025-02737-6.
PubMed 40275407
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT05803369
- Acronym / sponsor ID
- W81XWH-22-1-0168
- Conditions
- Autism Spectrum Disorder, Emotion Regulation
- Keywords
- Regulating Together
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Alabama at Birmingham
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 7 Apr 2023 (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.
Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.
Detailed description
144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS) groups. Participants will complete assessments at five time points: Screen (T1) Week 0 - where they will complete consent; Baseline (T2); Week 7: Post Active Treatment (includes semi-structured interviews) (T3); Week 16: Post Generalization (T4); Week 29: Final outcome visit (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regulating Together (RT) | Experimental | Behavioral: Regulating Together (RT)Participants will receive Regulating Together -the emotion dysregulation intervention |
| Achieving Independence and Mastery in School (AIMS) | Active comparator | Behavioral: Achieving Independence and Mastery in School (AIMS)Participants will receive AIMS, the academic functioning/organizational skill intervention. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Diagnosis of autism spectrum disorder (ASD)
- A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test
- Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R).
- Caregivers and child are fluent in speaking English
- Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3.
Key exclusion criteria (4 listed)
- Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.
- any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches.
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
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 |
|---|---|---|
| Regulating Together (RT)Regulating Together is an intensive outpatient group treatment targeting emotion dysregulation. It engages both caregivers and children and utilizes evidence-based intervention techniques including cognitive behavioral therapy (CBT), visuals, reinforcements, and scaffolding, and newer interventions such as mindfulness and acceptance-based therapy. | Behavioural | Regulating Together (RT) |
| Achieving Independence and Mastery in School (AIMS)AIMS is a school-based program developed to help students with social-communication challenges (such as autism spectrum disorder) achieve academic success. It is well-established and has been used with autistic youth, both in schools and in outpatient settings. | Behavioural | Achieving Independence and Mastery in School (AIMS) |
Primary outcome
Emotion Dysregulation Inventory- Reactivity
Time frame: Through study completion, about 29 weeks
13-item parent report measure that captures negative emotional responses and Dysphoria characterized by increased negative affect and lack of motivation. Higher scores mean higher emotional reactivity.
3 secondary outcomes
Children's Organizational Skills Scale (COSS)
Time frame: Through study completion, about 29 weeks
Daily Phone Diary
Time frame: Through study completion, about 29 weeks
Inpatient Hospitalization Rates
Time frame: during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 42217453Kang S, Burkett K, Sarawgi S, Ruberg J, Paustian J, Reisinger DL, Schmitt LM, Shaffer RC. Regulating Together: Caregivers' experiences in a shared journey through an emotion dysregulation intervention for autistic youth. Res Dev Disabil. 2026 Jul;174:105317. doi: 10.1016/j.ridd.2026.105317. Epub 2026 May 31.
- Derived from this study: PubMed 40275407McKinney WS, Tadevich LJ, Schmitt LM, Horn PS, Ruberg JR, White SW, Reisinger DL, Burkett KW, Sarawgi S, Kang S, Shaffer RC. Study protocol for a randomized controlled trial of Regulating Together (RT), a group therapy for emotion dysregulation in school-age autistic youth and their caregivers. BMC Psychol. 2025 Apr 24;13(1):436. doi: 10.1186/s40359-025-02737-6.
Related trials for Autism Spectrum Disorder
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
RecruitingPhase 4
AWARE: Management of ADHD in Autism Spectrum Disorder
ADHD, 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. This study is not recruiting at the moment.
Rebecca Shaffer principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulating Together (RT) and Achieving Independence and Mastery in School (AIMS) in people with Autism Spectrum Disorder and Emotion Regulation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 22 Oct 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Dysregulation Inventory- Reactivity (time frame: Through study completion, about 29 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803369, which also lists 2 linked publications.
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 22 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.