Clinical trial NCT01463241: Behavioral and Affective Skills in Coping (BASIC) Open Trial
Official title: Behavioral and Affective Skills in Coping: Practice-Adapted Child Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorders
Disruptive Behavior Disorders
Lead sponsor: Judge Baker Children's Center
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of the project is to develop and assess the feasibility of a brief, practice-friendly approach to psychotherapy for children, entitled Behavioral and Affective Skills in Coping (BASIC) and designed for use as a first step toward evidence-based practice by practitioners in clinical service settings.

Detailed description: The investigators seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. Because many empirically supported treatments for youth disorders address only one area of impairment, they may not be an ideal fit to community clinics, where (a) most practitioners treat an array of disorders rather than specializing in just one, (b) most referred youths present with multiple disorders, and (c) priority problems and treatment needs may shift for many youths during an episode of care. Moreover, because many evidence-based treatments have been developed in research settings, they may not be designed in ways that are ideal for front-line therapists in community settings. The investigators hope to reduce the difficulty of transporting treatments into community practice by incorporating the perspectives of community practitioners in the development and design of the protocol. By incorporating the feedback of expert treatment developers, the investigators hope to ensure that BASIC is not only appealing to users but also consistent with what has been learned through treatment research over the years. Finally, the trial will provide preliminary evidence on whether this brief "first course" in evidence-based treatment is beneficial for youths with depression, anxiety, and disruptive behavior problems-three clusters that account for a large percentage of youth referrals.

Eligibility criteria: Inclusion Criteria:

* 8-15 year-old youth
* The youth will meet diagnostic criteria for one or more target disorders in the broad areas of anxiety (including Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Obsessive Compulsive Disorder, Specific Phobia, Panic Disorder, Anxiety Disorder Not Otherwise Specified, Adjustment Disorder with Anxiety), depression (including Major Depressive Disorder, Dysthymic Disorder, Minor Depression, Depressive Disorder Not Otherwise Specified, Adjustment Disorder with Depressed Mood), and conduct (Oppositional Defiant Disorder, Conduct Disorder, Disruptive Behavior Disorder Not Otherwise Specified, Adjustment Disorder with Disturbance of Conduct).

Exclusion Criteria:

* Youth with primary ADHD
* Youth with developmental disorders
* Youth with symptoms of a thought disorder including delusions and hallucinations

Primary outcomes:
measure: Change from baseline in diagnostic status at post-treatment: Schedule for Affective Disorders and Schizophrenia for School-Age Children- Present and Lifetime Version (K-SADS-PL)
timeFrame: Immediately before and after the treatment course, which is expected to last an average of 7 months
measure: Change from baseline in child/adolescent problem areas at post-treatment: Child Behavior Checklist -- Problem Portion (CBCL)
timeFrame: Immediately before and after the treatment course, which is expected to last an average of 7 months
measure: Change from baseline in child/adolescent problem areas at post-treatment: Youth Self-Report Form -- Problem Portion (YSR)
timeFrame: Immediately before and after the treatment course, which is expected to last an average of 7 months
measure: Change from baseline in child/adolescent problem areas during treatment and at post-treatment: Brief Problem Checklist (BPC; Chorpita, Reise, Weisz, et al. 2010)
timeFrame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
measure: Change from baseline in target problem during treatment and at post-treatment: Weekly Target Problem Report (TPR; STEPs Team, 2008)
timeFrame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
measure: Change from baseline in clinical global impression during treatment course: Clinical Global Impression-Improvement (CGI-I) Scale (Guy, 1970).
timeFrame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
Secondary outcomes:
measure: Services for Children & Adolescents - Parent Interview (SCAPI; Jensen et al., 2004)
timeFrame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
measure: Service Assessment for Children and Adolescents-Treatment and Auxiliary Service Use Scales (SACA; Horwitz et al., 2001)
timeFrame: Participants will be followed for the duration of the treatment course, an expected average of 7 months
measure: Therapeutic Alliance Scale for Children (TASC; Shirk & Saiz, 1992)
timeFrame: Following the participant's treatment course, which is expected to last an average of 7 months
measure: Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)
timeFrame: Following the participant's treatment course, which is expected to last an average of 7 months
measure: Parent Child Satisfaction Scales (PCSS; Hawley, Weersing, & Weisz, 1998)
timeFrame: Following the participant's treatment course, which is expected to last an average of 7 months
measure: Therapist Satisfaction Inventory (TSI; Addis & Krasnow's, 2000)
timeFrame: Following the clinician's participation in the study, which is anticipated to last 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Judge Baker Children's Center
state: Massachusetts
Study officials:
affiliation: Department of Psychology, Harvard University
name: John R Weisz, Ph.D., ABPP
role: PRINCIPAL_INVESTIGATOR
References: