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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-AR210169 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regulating Together (RT) | Experimental | Participants will receive Regulating Together -the emotion dysregulation intervention |
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| Achieving Independence and Mastery in School (AIMS) | Active Comparator | Participants will receive AIMS, the academic functioning/organizational skill intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regulating Together (RT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, about 29 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, about 29 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Shaffer | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42217453 | Derived | 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. | |
| 40275407 | Derived |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
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| ID | Term |
|---|---|
| D012574 | Schools |
| ID | Term |
|---|---|
| D000072182 | Non-Medical Public and Private Facilities |
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| Achieving Independence and Mastery in School (AIMS) | Behavioral | 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. |
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| Daily Phone Diary | Phone interview administered by staff that documents Frequency and Intensity of Behavioral and Emotional Outbursts over a 2 day period. | Through study completion, about 29 weeks |
| Inpatient Hospitalization Rates | chart review and caregiver report for any psychiatric hospitalizations | during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult |
| McKinney 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. |
| D012919 | Social Behavior |
| D001519 | Behavior |