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Behavioral and Affective Skills in Coping (BASIC) Open Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John R. Weisz, PhD, ABPP, Harvard University
ClinicalTrials.gov Identifier:
NCT01463241
First received: October 26, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Anxiety Disorders
Depressive Disorders
Disruptive Behavior Disorders
Behavioral: Behavioral and Affective Skills in Coping (BASIC)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Behavioral and Affective Skills in Coping: Practice-Adapted Child Psychotherapy

Resource links provided by NLM:


Further study details as provided by Judge Baker Children's Center:

Primary Outcome Measures:
  • 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) [ Time Frame: Immediately before and after the treatment course, which is expected to last an average of 7 months ] [ Designated as safety issue: No ]
    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).

  • Change from baseline in child/adolescent problem areas at post-treatment: Child Behavior Checklist -- Problem Portion (CBCL) [ Time Frame: Immediately before and after the treatment course, which is expected to last an average of 7 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in child/adolescent problem areas at post-treatment: Youth Self-Report Form -- Problem Portion (YSR) [ Time Frame: Immediately before and after the treatment course, which is expected to last an average of 7 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in child/adolescent problem areas during treatment and at post-treatment: Brief Problem Checklist (BPC; Chorpita, Reise, Weisz, et al. 2010) [ Time Frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in target problem during treatment and at post-treatment: Weekly Target Problem Report (TPR; STEPs Team, 2008) [ Time Frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in clinical global impression during treatment course: Clinical Global Impression-Improvement (CGI-I) Scale (Guy, 1970). [ Time Frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Services for Children & Adolescents - Parent Interview (SCAPI; Jensen et al., 2004) [ Time Frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months ] [ Designated as safety issue: No ]
    The SCAPI is an interview administered to parents to assess children's services use across primary care, specialty mental health, and other settings. It is administered in two parts. In Part I, parents are asked about psychotropic medications the child receives. In Part II, parents are asked to document any recent visits the child has made to their physician. Test-retest κ values ranged from .49 to 1.00, with an overall κ value for all services of .97.

  • Service Assessment for Children and Adolescents-Treatment and Auxiliary Service Use Scales (SACA; Horwitz et al., 2001) [ Time Frame: Participants will be followed for the duration of the treatment course, an expected average of 7 months ] [ Designated as safety issue: No ]
    The SACA is a standardized interview for parents that collects information on use of mental health services across a broad spectrum (including outpatient, inpatient, and school-based). SACA reliability and validity data are well-documented.

  • Therapeutic Alliance Scale for Children (TASC; Shirk & Saiz, 1992) [ Time Frame: Following the participant's treatment course, which is expected to last an average of 7 months ] [ Designated as safety issue: No ]
    The TASC assesses the quality of youths' working alliance with their therapists. Originally designed to examine youth in inpatient settings, the 9-item revised scale comes in both a youth-report form and a parent-report form (parents reporting on their youth's relationship with the therapist). The TASC has demonstrated adequate internal consistency ranging from .72 to .74.

  • Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005) [ Time Frame: Following the participant's treatment course, which is expected to last an average of 7 months ] [ Designated as safety issue: No ]
    The TPOCS-A assesses child-clinician and caregiver-clinician alliance through observational ratings of recorded therapy sessions. The TPOCS-A was derived from questionnaire measures of alliance, adapting items that could be expressed in terms of observable behavior, both reflecting alliance or its absence. Psychometric analyses based on child and caregiver sessions in community outpatient clinics showed that both child and caregiver forms have good inter-rater reliability and internal consistency. Psychometric analyses also found that both child and caregiver forms predicted treatment outcome.

  • Parent Child Satisfaction Scales (PCSS; Hawley, Weersing, & Weisz, 1998) [ Time Frame: Following the participant's treatment course, which is expected to last an average of 7 months ] [ Designated as safety issue: No ]
    The Parent Child Satisfaction Scales consist of an 8-item parent measure and an 8-item child measure that assess the child's satisfaction with the treatment he or she received as well as the parents' satisfaction with their child's treatment.

  • Therapist Satisfaction Inventory (TSI; Addis & Krasnow's, 2000) [ Time Frame: Following the clinician's participation in the study, which is anticipated to last 18 months ] [ Designated as safety issue: No ]
    The TSI is a 16-item therapist-report measure derived from Addis & Krasnow's (2000) report on therapist attitudes toward manualized treatments. The items encompass whether therapists liked the treatment approach they used, whether they perceived that the approach was effective, whether they believe it allowed them to individualize treatment to fit client needs, and whether the approach seems appropriate for the kinds of children they most often see.


Enrollment: 24
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BASIC treatment
As an open trial, all participants in this study will receive the BASIC treatment.
Behavioral: Behavioral and Affective Skills in Coping (BASIC)
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.

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

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463241

Locations
United States, Massachusetts
Judge Baker Children's Center
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Judge Baker Children's Center
Investigators
Principal Investigator: John R Weisz, Ph.D., ABPP Department of Psychology, Harvard University
  More Information

No publications provided

Responsible Party: John R. Weisz, PhD, ABPP, Professor of Psychology, Harvard University
ClinicalTrials.gov Identifier: NCT01463241     History of Changes
Other Study ID Numbers: R34MH085963-03
Study First Received: October 26, 2011
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Attention Deficit and Disruptive Behavior Disorders
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014