| Protocol ID | NCT03432832 |
| Registration Date | 2018-02-14 |
| Status | completed |
| Sponsor | University of Pittsburgh |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2018-01-30 |
| Last Patient Out | 2024-07-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 12 Years - 21 Years |
NCT03432832
Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
| Field |
GLM
glm-5.1 11657ms / 9477 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 7056ms / 10665 tok |
OPENAI
gpt-4o Thinking: o3 4720ms / 9257 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | yes | yes | yes | OK |
| intervention_complex |
no
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The EASE intervention is a multicomponent program that fundamentally combines individual therapy sessions with active parent involvement, community practice, and a secure website (e-Coach) designed to interact and augment overall treatment intensity.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The EASE intervention combines multiple interacting components from different categories: behavioral therapy sessions with therapists, parent involvement/training, community practice sessions, and an online support platform (e-Coach), creating a multimodal approach that explicitly integrates individual therapy, family involvement, and technology-based supports.
Thinking: no — EASE is a single behavioral intervention for emotion regulation delivered through multiple modalities (therapy sessions, parent involvement, online support), not distinct interacting components from different categories.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The EASE program is a behavioral intervention focused on emotion regulation, mindfulness, and skill enhancement and does not combine distinct components from different categories.
Thinking: no — EASE is a single-modality behavioral/psychological therapy (mindfulness-based skills training) even though it includes parent and web supports, so it lacks multiple distinct intervention types from different categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial includes the Brief Psychiatric Rating Scale (BPRS) to measure psychiatric symptoms and the Emotion Dysregulation Inventory (EDI) to assess emotional reactivity.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The Brief Psychiatric Rating Scale (BPRS) is listed as a secondary outcome, which is a validated instrument that measures psychiatric symptoms including depression and anxiety.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measures include the Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF), which evaluates emotional reactivity and regulation, directly addressing symptoms in the study population.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes measure symptom severity (emotion dysregulation, psychiatric symptoms, and overall clinical improvement), which falls under the symptom category.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary and secondary outcomes measure symptom severity and emotional regulation functioning, which fall under symptom-related categories.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All outcomes focus on symptom improvement and quality of life through emotion regulation adjustment.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |