Childhood Aggression Clinical Trial
Official title:
Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation
I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children
(DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60
children in the comparison condition).
II: Finalize therapist training manuals and educational materials to guide selection,
training, and supervision of treatment providers.
Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment
attendance, treatment satisfaction, and any differences in these rates by groups.
Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly
greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.
Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and
externalizing symptoms.
Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer
internalizing and externalizing symptoms.
Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation,
risk taking, and social skills, and reducing depression.
Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly
greater improvement in adaptive coping skills, emotion regulation, risk taking and
impulsivity and social skills, and reducing depressive symptoms.
Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.
Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer
critical incidents, including psychiatric hospitalization, emergency room visits, total
number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting
out, running away, stealing, police involvement, etc.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02048241 -
Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder
|
Phase 4 |