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Study Title and Description

Seeking safety therapy for adolescent girls with PTSD and substance use disorder: a randomized controlled trial.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Seeking safety therapy for adolescent girls with PTSD and substance use disorder: a randomized controlled trial.
Author Najavits LM., Gallop RJ., Weiss RD.
Country Harvard Medical School, Boston, MA 02445, USA. lisa_najavits@hms.harvard.edu
Year 2006
Numbers Pubmed ID: 16858633

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 CBT Seeking Safety psychotherapy
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2 TAU
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Design Details
Question... Follow Up Answer Follow-up Answer
Should this citation be included? Yes
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Does this paper originate from a primary study of interest? No
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No
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No
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Ages eligible (in years) NR
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NR
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Total sample size (in all arms) 33
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Age distribution of enrolled population (in years) 16.06
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NR
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Substance used SUD (not further described, except maybe excluding nicotine)
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SUD (not further described, except maybe excluding nicotine)
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Interventions studied? Behavioral
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Behavioral
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Behavioral
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Outcome? Self report of use/abstinence and/or intensity
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Substance-related problems or symptoms scale
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Mental health
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Other ... Cognition; Treatment satisfaction; Adherence
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Age variation of enrolled population (in years) 1.22
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NR
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NR
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NR
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NR
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Study type RCT
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Income level of country(ies) of origin Upper income
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Upper income
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Upper income
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Results & Comparisons


Results Data
Outcome: PEI      Population: All Participants
Time Point Measure CBT TAU


0 months

N Analyzed 18 15
Mean 9.08 13.92
SD 6.36 7.83
SE


3 months

N Analyzed 18 15
Mean 5.75 14.29
SD 5.57 7.87
SE


6 months

N Analyzed 18 15
Mean 7.00 14.29
SD 8.73 6.73
SE
Outcome: APS      Population: All Participants
Time Point Measure CBT TAU


0 months

N Analyzed 18 15
Mean 0.62 0.84
SD 0.43 0.42
SE


3 months

N Analyzed 18 15
Mean 0.16 0.69
SD 0.23 0.38
SE


6 months

N Analyzed 18 15
Mean 0.50 0.52
SD 0.24 0.49
SE


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation Yes
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators Yes
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups Yes
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Timing of outcome assessments (detection bias): Detection bias because important outcomes were not measured at the same time across groups Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. Unsure
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Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Unclear
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low Staff being blind on page 455 was actually allocation concealment.
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study High
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Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. High
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. High Mostly self-reported outcomes
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting High 21% missingness
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Quality Rating
No quality rating data was found.