Introduces topic (1), cites article to be appraised, and appraisal tool utilized (1), provides 2-3 sentences summarizing the ov
Introduces topic (1), cites article to be appraised, and appraisal tool utilized (1), provides 2-3 sentences summarizing the overarching strengths and weaknesses of the article (2), and includes summary statement that indicates that the article was “include”, “seek further information” or “exclude” (1)
Chooses 2 criteria from the assigned appraisal tool that were found to be weaknesses or that introduced bias into the study. In a sentence state what the 2 criteria are that you will be expanding upon
1. Explains each of the 2 criteria and why it is important 2. States whether and how the article meets the desired level of quality for the criteria 3. Cites the article, the appraisal tool, and other resources as necessary for explanation.
Article is CAMELS and appriasal tool is CASP both attached below.
CASP Randomised Controlled Trial Standard Checklist: 11 questions to help you make sense of a randomised controlled trial (RCT)
Main issues for consideration: Several aspects need to be considered when appraising a randomised controlled trial:
Is the basic study design valid for a randomised controlled trial? (Section A)
Was the study methodologically sound? (Section B) What are the results? (Section C) Will the results help locally? (Section D)
The 11 questions in the checklist are designed to help you think about these aspects systematically.
How to use this appraisal tool: The first three questions (Section A) are screening questions about the validity of the basic study design and can be answered quickly. If, in light of your responses to Section A, you think the study design is valid, continue to Section B to assess whether the study was methodologically sound and if it is worth continuing with the appraisal by answering the remaining questions in Sections C and D.
Record ‘Yes’, ‘No’ or ‘Can’t tell’ in response to the questions. Prompts below all but one of the questions highlight the issues it is important to consider. Record the reasons for your answers in the space provided. As CASP checklists were designed to be used as educational/teaching tools in a workshop setting, we do not recommend using a scoring system.
About CASP Checklists: The CASP RCT checklist was originally based on JAMA Users’ guides to the medical literature 1994 (adapted from Guyatt GH, Sackett DL and Cook DJ), and piloted with healthcare practitioners. This version has been updated taking into account the CONSORT 2010 guideline (http://www.consort-statement.org/consort-2010, accessed 16 September 2020).
Citation: CASP recommends using the Harvard style, i.e. Critical Appraisal Skills Programme (2020). CASP (insert name of checklist i.e. Randomised Controlled Trial) Checklist. [online] Available at: insert URL. Accessed: insert date accessed.
©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial- Share A like. To view a copy of this licence, visit https://creativecommons.org/licenses/by-sa/4.0/
Critical Appraisal Skills Programme (CASP) part of Oxford Centre for Triple Value Healthcare Ltd www.casp-uk.net
2
Study and citation: …………………………………………………………………………………………………………
Section A: Is the basic study design valid for a randomised controlled trial?
1. Did the study address a clearly focused research question? CONSIDER: Was the study designed to assess the outcomes of an intervention? Is the research question ‘focused’ in terms of: • Population studied • Intervention given • Comparator chosen • Outcomes measured?
Yes No Can’t tell o o
2. Was the assignment of participants to interventions randomised? CONSIDER: • How was randomisation carried out? Was
the method appropriate? • Was randomisation sufficient to eliminate
systematic bias? • Was the allocation sequence concealed
from investigators and participants?
Yes No Can’t tell o o o
3. Were all participants who entered the study accounted for at its conclusion? CONSIDER: • Were losses to follow-up and exclusions
after randomisation accounted for? • Were participants analysed in the study
groups to which they were randomised (intention-to-treat analysis)?
• Was the study stopped early? If so, what was the reason?
Yes No Can’t tell o o o
Section B: Was the study methodologically sound?
4. • Were the participants ‘blind’ to
intervention they were given? • Were the investigators ‘blind’ to the
intervention they were giving to participants?
• Were the people assessing/analysing outcome/s ‘blinded’?
Yes No Can’t tell
o o o o o
o o o
5. Were the study groups similar at the start of the randomised controlled trial? CONSIDER: • Were the baseline characteristics of each
study group (e.g. age, sex, socio-economic group) clearly set out?
• Were there any differences between the study groups that could affect the outcome/s?
Yes No Can’t tell o o o
3
6. Apart from the experimental intervention, did each study group receive the same level of care (that is, were they treated equally)?
CONSIDER: • Was there a clearly defined study protocol? • If any additional interventions were given
(e.g. tests or treatments), were they similar between the study groups?
• Were the follow-up intervals the same for each study group?
Yes No Can’t tell o o o
Section C: What are the results?
7. Were the effects of intervention reported comprehensively?
CONSIDER:
• • What outcomes were measured, and were
they clearly specified? • How were the results expressed? For
binary outcomes, were relative and absolute effects reported?
• Were the results reported for each outcome in each study group at each follow-up interval?
• Was there any missing or incomplete data? • Was there differential drop-out between the
study groups that could affect the results? • Were potential sources of bias identified? • Which statistical tests were used? • Were p values reported?
Yes No Can’t tell o o o
8. Was the precision of the estimate of the intervention or treatment effect reported?
CONSIDER: • Were confidence intervals (CIs) reported?
Yes No Can’t tell o o o
9. Do the benefits of the experimental intervention outweigh the harms and costs?
CONSIDER: • What was the size of the intervention or
treatment effect? • Were harms or unintended effects
reported for each study group? • Was a cost-effectiveness analysis
undertaken? (Cost-effectiveness analysis allows a comparison to be made between different interventions used in the care of the same condition or problem.)
Yes No Can’t tell o o o
Was a power calculation undertaken?
4
Section D: Will the results help locally?
10. Can the results be applied to your local population/in your context?
CONSIDER: • Are the study participants similar to the
people in your care? • Would any differences between your
population and the study participants alter the outcomes reported in the study?
• Are the outcomes important to your population?
• Are there any outcomes you would have wanted information on that have not been studied or reported?
• Are there any limitations of the study that would affect your decision?
Yes No Can’t tell o o o
11. Would the experimental intervention provide greater value to the people in your care than any of the existing interventions?
CONSIDER: • What resources are needed to introduce
this intervention taking into account time, finances, and skills development or training needs?
• Are you able to disinvest resources in one or more existing interventions in order to be able to re-invest in the new intervention?
Yes No Can’t tell o o o
APPRAISAL SUMMARY: Record key points from your critical appraisal in this box. What is your conclusion about the paper? Would you use it to change your practice or to recommend changes to care/interventions used by your organisation? Could you judiciously implement this intervention without delay?
- Study and citation:
- Section D Will the results help locally:
- Check Box2: Off
- Q:
- 1 consideration answers:
- 2 consideration answers:
- 3 consideration answers:
- 5 consideration answers:
- 6 consideration answers:
- 7 consideration answers:
- 8 consideration answers:
- 9 consideration answers:
- 10 consideration answers:
- 11 consideration answers:
- Check Box3: Off
- Check Box1: Off
- Check Box4: Off
- Check Box5: Off
- Check Box6: Off
- Check Box7: Off
- Check Box9: Off
- Check Box10: Off
- Check Box11: Off
- Check Box13: Off
- Check Box14: Off
- Check Box15: Off
- Check Box12: Off
- Check Box16: Off
- Check Box17: Off
- Check Box18: Off
- Check Box19: Off
- Check Box20: Off
- Check Box21: Off
- Check Box22: Off
- Check Box23: Off
- Check Box24: Off
- Check Box25: Off
- Check Box26: Off
- Check Box27: Off
- Check Box28: Off
- Check Box29: Off
- Check Box30: Off
- Check Box31: Off
- Check Box32: Off
- Check Box33: Off
- Check Box34: Off
- Check Box35: Off
- Check Box36: Off
- Check Box37: Off
- Check Box38: Off
- Check Box39: Off
- Check Box40: Off
- APPRAISAL SUMMARY:
,
NEW RESEARCH
Results From the Child/Adolescent Anxiety Multimodal Extended Long-Term Study (CAMELS): Primary Anxiety Outcomes Golda S. Ginsburg, PhD, Emily M. Becker-Haimes, PhD, Courtney Keeton, PhD, Philip C. Kendall, PhD, ABPP, Satish Iyengar, PhD, Dara Sakolsky, MD, Anne Marie Albano, PhD, Tara Peris, PhD, Scott N. Compton, PhD, John Piacentini, PhD, ABPP
Objective: To report anxiety outcomes from the multisite Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS). Rates of stable anxiety remission (defined rigorously as the absence of all DSM-IV TR anxiety disorders across all follow-up years) and predictors of anxiety remission across a 4-year period, beginning 4 to 12 years after randomization to 12 weeks of medication, cognitive-behavioral therapy (CBT), their combination, or pill placebo were examined. Examined predictors of remission included acute treatment response, treatment assignment, baseline child and family variables, and interim negative life events.
Method: Data were from 319 youths (age range 10.9�25.2 years; mean age 17.12 years) originally diagnosed with separation, social, and/or generalized anxiety disorders and enrolled in the multi-site Child/Adolescent Anxiety Multimodal Study (CAMS). Participants were assessed annually by independent evaluators using the age-appropriate version of the Anxiety Disorders Interview Schedule and completed questionnaires (eg, about family functioning, life events, and mental health service use).
Results: Almost 22% of youth were in stable remission, 30% were chronically ill, and 48% were relapsers. Acute treatment responders were less likely to be in the chronically ill group (odds ratio ¼ 2.73; confidence interval ¼ 1.14�6.54; p < .02); treatment type was not associated with remission status across the follow-up. Several variables (eg, male gender) predicted stable remission from anxiety disorders.
Conclusion: Findings suggest that acute positive response to anxiety treatment may reduce risk for chronic anxiety disability; identified predictors can help tailor treatments to youth at greatest risk for chronic illness.
Clinical Trial Registration Information: Child and Adolescent Anxiety Disorders (CAMS). http://clinicaltrials.gov/; NCT00052078.
Key words: anxiety, treatment, follow-up, cognitive-behavior therapy, sertraline
J Am Acad Child Adolesc Psychiatry 2018;57(7):471–480.
P
Journal of t Volume 57
ediatric anxiety disorders are highly prevalent, are associated with severe disability, and confer high personal and economic costs.1-3 These illnesses
are chronic, as data from retrospective and prospective studies show high degrees of continuity for anxiety disorders as children reach adolescence and adulthood.4-6 Conse- quently, identifying factors that interrupt the progression or persistence of these illnesses is paramount. One key factor may be early and effective treatment. Two evidenced-based treatments, cognitive-behavioral therapy (CBT) and selec- tive serotonin reuptake inhibitor (SSRI) use, have been shown to reduce anxiety and related impairment in the short term.7 However, data on whether an acute positive response to these treatments reduces risk of anxiety disability years later are limited. A recent review of studies examining the long-term benefits of treatments for pediatric anxiety disorders concluded that the majority of youths
he American Academy of Child & Adolescent Psychiatry / Number 7 / July 2018
receiving cognitive-behavioral treatment no longer meet diagnostic criteria for their initial anxiety diagnosis at an average of 5.85 years after treatment.8 However, studies in this review were cross-sectional (ie, a one-time assessment at follow-up) and consequently may over- or underestimate the long-term benefits of treatment. Follow-up studies of medication or combination treatment are lacking.
Our study, called the Child/Adolescent Anxiety Multi- modal Extended Long-term Study (CAMELS),9 was designed to address this issue by examining the long-term outcomes of anxious youth across 4 consecutive years1 who were initially randomized in the landmark Child/Adolescent Anxiety Multimodal Study (CAMS)7 to 1 of 4 treatment conditions (ie, CBT, SSRI, combination of SSRI and CBT, or pill placebo). Youth entered the CAMELS study between 4 and 12 years after their initial randomization in the CAMS. After study entry, participants were expected to be assessed
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GINSBURG et al.
annually over 5 consecutive years. Specifically, each year participants were asked to complete one “long” and “short” visit. During each long visit, a diagnostic evaluation was completed, along with several self- and parent-report ques- tionnaires. During the “short” visits, study staff conducted telephone interviews to complete questions about mental health symptoms and service use. Data presented in this article were obtained during long visits only that were completed over 4 consecutive years. The current study examined the following: (1) rates of stable anxiety disorder remission (as well as relapse and chronicity), and (2) pre- dictors of stable remission across the follow-up period. Examined predictors included the following: acute treatment response (ie, clinically meaningful improvement measured 12 weeks after randomization) to one of the CAMS treatments; the CAMS treatment assignment (sertraline, CBT, their combination, or pill placebo); the CAMS baseline child and family variables (ie, demographics, child clinical characteris- tics, presence of study entry diagnoses, family/parent func- tioning); and interim negative life events between the CAMS and this follow-up study. Data examining the long-term outcomes of treated youth can provide important informa- tion about downstream anxiety disability and estimates and expectations for prognosis to families. These data can also inform possible preventive efforts. Examining predictors of youth outcomes over time can help identify needed modifi- cations for subgroups of anxious youth, regardless of treat- ment type, to enhance maintenance of treatment gains and to reduce relapse. Moreover, the specific predictors examined in this study were selected in light of literature indicating their relation to acute and/or long-term anxiety treatment response.10 Based on the recent review of long-term treat- ment outcomes for anxious youth,8 we hypothesized that approximately 60% of youth would be in stable remission. With respect to predictors, we hypothesized that the CAMS treatment responders (compared to nonresponders), regard- less of treatment type, would more likely be in remission. Given that youth who received combination treatment were more likely to be acute treatment responders, we hypothe- sized that they would be more likely to be in stable remission at the follow-up.
METHOD Participants Participants were 319 volunteer families previously enrolled in the CAMS (representing 65.3% of the original sample of 488). All youth in the CAMS at baseline were between 7 and 17 years of age and met criteria for social, generalized, and/or separation anxiety disorder according to the Diag- nostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR). The average age range
472 www.jaacap.org
of these youth at the time of their first CAMELS follow-up assessment was 17.12 years (range ¼ 10.9�25.2 years). Average length of time since initial randomization to a CAMS treatment condition and the first CAMELS follow- up assessment was 6.51 years (SD ¼ 1.65). The length of time varied by participant based on enrollment date in the CAMS and recruitment date into CAMELS. Table 1 dis- plays the demographic and clinical characteristics of those enrolled in CAMELS (n ¼ 319) and those CAMS partici- pants who did not participate in CAMELS (n ¼ 169).
Measures Anxiety Disorders. Presence of current anxiety disorder was assessed annually at each long visit using the age-appropriate version of the Anxiety Disorders Interview Schedule for DSM- IV (ADIS).11,12 The ADIS interviews are the gold standard assessment tools for determining anxiety disorders, were used in the CAMS, and have been well validated. In the current study, interrater diagnostic agreement (ie, k values) were all greater than 0.90 for anxiety diagnoses based on a randomly selected sample (n ¼ 90; 28%) of ADIS ad- ministrations. Diagnostic agreement was defined as matching on the presence or absence of a disorder and a Clinical Severity Rating within one point. Within-person trajectories of anxiety disorders over the follow-up period were assessed by creating three groups of youths who completed three or more annual ADIS assessments: (1) re- mitters, defined rigorously as youth who did not meet diagnostic criteria for any anxiety disorder (defined as any DSM-IV TR anxiety disorder, including post-traumatic stress disorder and obsessive-compulsive disorder) at any follow-up visit; (2) chronic, defined as youth who met diagnostic criteria for one or more anxiety disorder at every follow-up visit; and (3) relapsers, youth who were anxiety diagnosis free during at least one follow-up visit and met diagnostic criteria for one or more anxiety disorders at another follow-up visit.
This definition of remission was selected over a less rigorous criterion, such as absence of all three of the CAMS entry disorders (generalized, social, and separation anxiety) or absence of a primary disorder only because numerous studies have demonstrated that pediatric anxiety disorders are highly comorbid (at both the symptom and disorder level) and manifest differently over the course of development (eg, separation anxiety disorder predicts later panic disorder). Thus, an overly narrow definition may confound conclusions about the long-term outcomes following anxiety treatment.
Predictor Variables CAMS Treatments. As noted, eligible youth were random- ized to 12 weeks of one of the following treatments (described
Journal of the American Academy of Child & Adolescent Psychiatry Volume 57 / Number 7 / July 2018
TABLE 1 Comparisons Between the Child/Adolescent Anxiety Multimodal Study (CAMS) and the Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS) Sample
All CAMELS Participants vs. Nonparticipants Participated in 1�2 Assessment Time Points vs. 3þ Time Points
Non participants (n ¼ 169)
CAMELS Participants (n ¼ 319) Statistic
1�2 Time Points Only (n ¼ 95)
3þ Time Points
(n ¼ 224) Statistic % % % %
Female gender 39.1 55.2 11.48**a 52.6 56.3 .35a
Ethnicity, Hispanic 19.5 8.2 13.45***a 9.5 7.6 .32a
Racial minority 26.0 18.5 3.78a 20.0 17.9 .20a
Tx condition 0.86a 1.71a
Combination 28.4 28.8 33.7 26.8 Sertraline 25.4 28.2 26.3 29.0 CBT 29.0 28.2 27.8 28.6 Placebo 17.2 14.7 12.6 15.6 CAMS Responseb 60.9 66.4 1.28a 75.9 62.8 4.60*a
Mean SD Mean SD Mean SD Mean SD
Baseline age 10.81 2.81 10.69 2.80 0.67c 10.82 2.72 10.55 2.83 0.78c
Hollingshead SES 44.45 12.07 49.70 10.99 L4.85***c 47.27 12.53 50.72 10.13 L2.59*c
Baseline CGI-S 5.05 0.76 5.01 0.71 0.59c 5.05 .74 5.00 0.70 0.66c
Baseline CGAS 51.21 6.99 50.45 7.17 1.13c 50.93 7.26 50.24 7.13 0.78c
Baseline # Dx 2.89 1.28 3.00 1.19 L0.92c 3.02 1.25 2.99 1.17 0.21c
Baseline Parent BFAM
11.11 5.75 10.95 5.12 0.30c 11.61 4.76 10.69 5.24 1.40c
Parent BSI 0.50 0.46 0.47 0.40 0.76c 0.49 0.42 0.46 0.39 0.52c
Years since Randomizationd
— — — — — 7.29 1.94 6.19 1.39 5.69***
Note: BFAM ¼ Brief Family Assessment of Functioning Measure; BSI ¼ Brief Symptom Inventory; CBT ¼ cognitive-behavioral therapy; CGAS ¼ Children’s Global Assessment of Functioning Scale; CGI-S ¼ Clinical Global Impression�Severity Scale; Dx ¼ diagnosis; SES ¼ socioeconomic status. aFrom c2 test. bData presented on the CAMS posttreatment response status represent available data only. It should be noted that 31 youth who did not participate in CAMELS and 18 youth who did participate in CAMELS were missing data for their 12-week outcome assessment and were not included in this comparison. If the last observation carried forward (LOCF) data imputation method is used for this variable, then youth in the CAMELS are more likely to have been CAMS treatment responders than youth who did not participate in the CAMELS. cFrom t test. dNot applicable for non-CAMELS participants. *p < .05; **p < .01; ***p < .001.
LONG-TERM OUTCOMES FOR ANXIOUS YOUTH
in detailed elsewhere7): (1) CBT: CBT consisted of the age- appropriate versions of the Coping Cat protocol: Coping Cat for children and C.A.T. Project for Adolescents13,14. Both protocols included 12 individual child sessions (60 minutes each) and 2 parent-only sessions scheduled over 12 weeks. (2) Sertraline (SRT): SRT treatment consisted of eight 30- to 60-minute in-person sessions involving discussing anxiety symptoms, functioning, and adverse events within supportive clinical care. Medication was administered using a “fixed-flexible” dosing strategy that was linked to clinical response and side effects. In general, participants’ medication dose was adjusted upward in 50-mg/d increments if anxiety levels were moderate to high. The dose was held stable, or
Journal of the American Academy of Child & Adolescent Psychiatry Volume 57 / Number 7 / July 2018
adjusted downward, if the participant had few anxiety symptoms or if there were impairing side effects. (3) Com- bination treatment (COMB): COMB consisted of both CBT and SRT. (4) Pill placebo (PBO): PBO consisted of a double- blinded treatment that paralleled SRT. Youth assigned to PBO who were considered “nonresponders” to treatment were offered the CAMS CBT and/or medication.
CAMS Treatment Responder Status. CAMS treatment responder was defined using the Clinical Global Impression�Improvement Scale (CGI-I)15 assigned at posttreatment (ie, 12 weeks after randomization). The CGI- I is a 7-point scale (1 ¼ very much improved, 7 ¼ very
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GINSBURG et al.
much worse) completed by the independent evaluator. Youth with CGI-I scores of 1 (very much improved) or 2 (much improved) were categorized as treatment responders.
Negative Life Events. Negative life events were assessed at each completed CAMELS visit using the Life Events Scale (LES),16 which is a 35-item parent-report measure of exposure to a broad range of stressful events that cut across family, school, and social domains. Examples include death of a parent, change in income, school failure, illness, and moving. A total score was calculated reflecting the aggregate number of endorsed negative life events since CAMS and over the follow-up period.
CAMS Baseline Demographic Variables. Demographic variables included child age, gender, race/ethnicity (minor- ity versus nonminority), and socioeconomic status as measured by the Hollingshead Index,17 all reported by the participating parent.
CAMS Baseline Child Clinical Variables. Child clinical variables included a) anxiety symptom severity as measured by the Clinical Global Impression�Severity Scale (CGI-S).15 The CGI-S is a well-established measure that yields a global rating of anxiety severity ranging from 1 (not at all ill) to 7 (extremely ill) and b) comorbid disorders (internalizing and externalizing) based on the age-appropriate version of the ADIS. Internalizing disorders included any non�study entry anxiety or depressive disorder. Externalizing disorders included disruptive behavior disorders (eg, oppositional defiant disorder, attention-deficit/hyperactivity disorder).
CAMS Baseline Family/Parent Variables.. Brief Family Assessment Measure (BFAM)18 The BFAM is a 14-item measure completed by parents to assess overall family func- tioning (eg, “We take the time to listen to each other”). A total score was used, with higher scores indicating more family dysfunction (Cronbach’s a at the CAMS baseline was 0.84).
Brief Symptom Inventory (BSI)19 The BSI is a widely used 53-item parent-report measure of global psychiatric symptomatology (Cronbach’s a at the CAMS baseline was 0.95). For the present analyses, the Global Severity Index (BSI-GSI) provided a single composite score of current symptoms of somatization, obsessive-compulsive disorder, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychosis. Higher scores suggest greater severity of psychological distress.
Burden Assessment Scale (BAS)20 The BAS is a 21-item parent completed measure that assesses caregiver burden associated with having a child with a mental health disorder. Parents indicated how much the child’s anxiety disrupts family life, emotions, and routines on a scale ranging from
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1 (not at all) to 5 (very much). A total score was used, with higher score reflecting greater burden. Cronbach’s a at the CAMS baseline sample was 0.91.
Additional Control Variables To reduce bias associated with interim mental health service use, the Supplemental Services Form of the ADIS (SSF), assessed at each CAMELS long and short visit, was entered as a control variable in all analyses. The SSF was administered by a research assistant at each follow-up visit and assessed the use of a broad range of mental health services since the CAMS. Examples of these services include psychiatric hospitalization, psychotropic medication, and various kinds of psychotherapy (eg, family, supportive, psychodynamic). A dichotomous score (ie, yes/no for any use across all SSF items) was calcu- lated over the entire follow-up period; 238 youth (74.6%) reported receiving some sort of mental health service use over the follow-up. Additional control variables included treat- ment site (collected at the CAMS baseline) and time since the CAMS randomization (in years).
Procedures This was a naturalistic follow-up study conducted at six sites in the United States (Johns Hopkins University, University of California Los Angeles, University of Pittsburgh, Temple University, Duke University, and Columbia University) and approved by the respective institutional review boards. Prior to enrollment, and after complete description of the study, parents/guardians provided written informed consent and children provided assent. Recruitment for CAMELS began in 2011 and ended in 2015. Recruitment for the original treatment study, the CAMS, occurred between 2002 and 2007. In the CAMS, eligible youth were randomized into one of four treatment conditions: CBT only, SRT (sertraline medication) only, COMB (combination CBT and SRT), or PBO (placebo). At posttreatment (12 weeks after randomi- zation), youth were evaluated by independent evaluators who determined treatment response status. Youth assigned to pill placebo who were determined to be “nonresponders” were offered any active CAMS treatments. Receipt of subsequent treatment for anxiety was documented on the SSF and statistically controlled for in the current study.
The proposed CAMELS grant was a 5-year study. However, because of variations in study start-up and end dates at each recruitment site, sample sizes varied across the 5 years and resulted in a significantly lower sample size of participants completing all five annual assessments. 319 youth completed their first long CAMELS visit. The sample size of youth who completed their subsequent long visits were: year 2 ¼ 239, year 3 ¼ 220, year 4 ¼ 209; year 5 ¼
Journal of the American Academy of Child & Adolescent Psychiatry Volume 57 / Number 7 / July 2018
LONG-TERM OUTCOMES FOR ANXIOUS YOUTH
91; only 61 youth participated in all 5 long visits. Because of the low year 5 enrollment, the current study included only data obtained across 4 years.
Potentially eligible families for the current study were contacted via letter, social media outlets, and phone. Fam- ilies expressing interest provided written informed consent and then were expected to complete a maximum of five annual in-person evaluations, depending on when the family was enrolled. During these “long” evaluations, measures described above (and several others) were collected. Between each long visit (mid-way at 6 months), a phone evaluation was planned (referred to as a “short” visit), during which time only questionnaire data were collected. During the long visits, a trained independent evaluator administered the age-appropriate diagnostic interview and other measures used in this study. Short visits were con- ducted by research assistants. Each family was reimbursed $130 for completion of each long visit and $50 for each
FIGURE 1 Child/Adolescent Anxiety Multimodal Extended Long-
488 Enrolled in
140 Assigned to receive
sertraline and CBT
133 Assigned to receive
sertraline alone
319 Enrolled in CAMELS
92 (66% of 140)
Received sertraline and CBT
90 (68% of 133)
Received sertraline
alone
90 (65% of 139)
Received CBT alone
47 (62% of 76)
Received placebo
1 CAMELS visit: n = 18
2 CAMELS visits: n = 13
3 CAMELS visits: n = 8
4 CAMELS visits: n = 33
5
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