Behavioral and Affective Skills in Coping (BASIC) Open Trial

Anxiety Disorders Clinical Trial

— BASIC  

Official title:

Behavioral and Affective Skills in Coping: Practice-Adapted Child Psychotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463241
• Other study ID #: R34MH085963-03
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: April 15, 2015
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2015
• Source: Judge Baker Children's Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Attention Deficit and Disruptive Behavior Disorders
• Depression
• Depressive Disorder
• Depressive Disorders
• Disease
• Disruptive Behavior Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Judge Baker Children's Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Judge Baker Children's Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?s = .60 - 1.00), inter-rater reliability (?s = .60 - 1.00) and internal consistency (as = .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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Services for Children & Adolescents - Parent Interview (SCAPI; Jensen et al., 2004)	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 ? values ranged from .49 to 1.00, with an overall ? value for all services of .97.	Participants will be followed for the duration of the treatment course, an expected average of 7 months	No
Secondary	Service Assessment for Children and Adolescents-Treatment and Auxiliary Service Use Scales (SACA; Horwitz et al., 2001)	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.	Participants will be followed for the duration of the treatment course, an expected average of 7 months	No
Secondary	Therapeutic Alliance Scale for Children (TASC; Shirk & Saiz, 1992)	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.	Following the participant's treatment course, which is expected to last an average of 7 months	No
Secondary	Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)	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.	Following the participant's treatment course, which is expected to last an average of 7 months	No
Secondary	Parent Child Satisfaction Scales (PCSS; Hawley, Weersing, & Weisz, 1998)	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.	Following the participant's treatment course, which is expected to last an average of 7 months	No
Secondary	Therapist Satisfaction Inventory (TSI; Addis & Krasnow's, 2000)	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.	Following the clinician's participation in the study, which is anticipated to last 18 months	No