Behavioral and Affective Skills in Coping (BASIC) Open Trial

NCT01463241 | Completed

• 1 other identifier: R34MH085963-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorders; Disruptive Behavior Disorders

Outcome Measures

Primary Outcomes (6)

• 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)

  The K-SADS-PL (Puig-Antich \& Chambers, 1983; Kaufman et al., 1997) is a semi-structured diagnostic interview designed to be used for youth ages 6 through 18. The K-SADS-PL will be used to diagnose DSM-IV disorders, and has been found to have acceptable test-retest reliability (κs = .60 - 1.00), inter-rater reliability (κs = .60 - 1.00) and internal consistency (αs = .68 - .84), and to discriminate between disordered and non-disordered children (Ambrosini, 2000; Kaufman et al., 1997; Lewinsohn, et al., 1994).

  Immediately before and after the treatment course, which is expected to last an average of 7 months

• Change from baseline in child/adolescent problem areas at post-treatment: Child Behavior Checklist -- Problem Portion (CBCL)

  The CBCL obtains caregiver reports on 118 child/adolescent problems, each rated on a 0-1-2 scale. The CBCL is a widely-used and psychometrically sound measure with well-developed norms (Achenbach, 2001), and it yields T-scores for eight narrow-band syndrome scales (Anxious-Depressed, Withdrawn-Depressed, Somatic Complaints, Attention Problems, Thought Problems, Social Problems, Aggressive Behavior, and Rule-Breaking Behavior), two broad-band second-order syndrome scales (Internalizing and Externalizing), and a Total Problems scale.

  Immediately before and after the treatment course, which is expected to last an average of 7 months

• Change from baseline in child/adolescent problem areas at post-treatment: Youth Self-Report Form -- Problem Portion (YSR)

  The YSR is a 118-items assessing symptoms across a broad range of clinical significance, overlapping heavily with the content of the parent-report CBCL. The YSR is normed for children aged 11 and older, but item wording is quite simple, and data from clinic-referred children (Yeh \& Weisz, 2001) have shown that the measure performs as well psychometrically for children aged 7-10 as for youths aged 11-17; this suggests that the YSR may be appropriately employed with youngsters across the full age range of the current sample.

  Immediately before and after the treatment course, which is expected to last an average of 7 months

• Change from baseline in child/adolescent problem areas during treatment and at post-treatment: Brief Problem Checklist (BPC; Chorpita, Reise, Weisz, et al. 2010)

  The BPC is a 12-item questionnaire that has both parent and youth versions designed to provide a brief, easily administered, clinically relevant, and psychometrically sound measure of symptoms and problems. The items for this measure were developed using item response theory and factor analysis applied to the CBCL and YSR and ask about symptoms of internalizing and externalizing problems in the last week. Internal consistency for the BPC ranged from .70 to .83. Test-retest reliability was also good, with Cronbach's alpha falling in the range of .72 to.79.

  Participants will be followed for the duration of the treatment course, an expected average of 7 months

• Change from baseline in target problem during treatment and at post-treatment: Weekly Target Problem Report (TPR; STEPs Team, 2008)

  The TPR tracks trajectories of change in the target problems identified by caregivers and children at the start of treatment. In the initial assessment, the caregiver and child are separately asked to identify the "problems for which you/your child most need/s help." The 3 top-ranked problems are then rated for severity in weekly phone calls. TPR ratings have been shown to be sensitive to change over time and in ways that differ for different treatments; moreover, the TPR is a consumer-sensitive index of treatment response, reflecting the concerns for which caregiver and child sought help.

  Participants will be followed for the duration of the treatment course, an expected average of 7 months

• Change from baseline in clinical global impression during treatment course: Clinical Global Impression-Improvement (CGI-I) Scale (Guy, 1970).

  The CGI-I is a 7-point scale to be completed by practitioners each week, indicating their rating of client improvement relative to baseline severity. The CGI-I has been used as a measure of treatment response in studies testing CBT for anxiety disorders, CBT for depression, and Behavioral Caregiver Training for disruptive behavior in children with ADHD. The CGI-I has demonstrated acceptable convergent validity between clinicians and blind assessors rating children's response to treatment.

  Participants will be followed for the duration of the treatment course, an expected average of 7 months

Secondary Outcomes (6)

• Services for Children & Adolescents - Parent Interview (SCAPI; Jensen et al., 2004)

  Participants will be followed for the duration of the treatment course, an expected average of 7 months

• Service Assessment for Children and Adolescents-Treatment and Auxiliary Service Use Scales (SACA; Horwitz et al., 2001)

  Participants will be followed for the duration of the treatment course, an expected average of 7 months

• Therapeutic Alliance Scale for Children (TASC; Shirk & Saiz, 1992)

  Following the participant's treatment course, which is expected to last an average of 7 months

• Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)

  Following the participant's treatment course, which is expected to last an average of 7 months

• Parent Child Satisfaction Scales (PCSS; Hawley, Weersing, & Weisz, 1998)

  Following the participant's treatment course, which is expected to last an average of 7 months

Study Arms (1)

BASIC treatment

OTHER

As an open trial, all participants in this study will receive the BASIC treatment.

Behavioral: Behavioral and Affective Skills in Coping (BASIC)

Interventions

Behavioral and Affective Skills in Coping (BASIC) BEHAVIORAL

The investigator's 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. The BASIC protocol will include (a) a therapist manual guiding the use of five BASIC skills \[Belief Repair, Action, Solving Problems, Incentives, and Calming\]; (b) child and parent materials to facilitate learning skills, practicing them in-session, and using them outside sessions; and (c) a decision tree to guide judgments about which skills to use and when to switch skills or treatment focus.

BASIC treatment

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Judge Baker Children's Center: lead

Study Sites (1)

Judge Baker Children's Center

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Attention Deficit and Disruptive Behavior Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John R Weisz, Ph.D., ABPP

  Department of Psychology, Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: November 1, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

US (1)