Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05368571
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2022-05-06
Brief Title:
CHOICES-TEEN Randomized Controlled Trial
Sponsor:
Baylor University
Organization:
Baylor University
Study Overview
Official Title:
CHOICES-TEEN Efficacy of a Bundled Risk Reduction Intervention for Juvenile Justice Females
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled trial will 1 Test the efficacy of the CHOICES-TEEN CT intervention compared with an Attentional Control AC condition on reducing the risk of substance-exposed pregnancy SEP and HIVSTI among high-risk female youth involved with the juvenile justice system by reducing alcohol use increasing marijuana cessation reducing risk of pregnancy and increasing condom use 2 Test the efficacy of CT compared to AC on increasing cognitive self-regulation abilities 3 Test proposed intervention mediatorsmechanisms of action for CT overall and by raceethnicity and 4 Test the moderating effect of initial readiness to change on risk of SEP and risk of HIVSTI
Detailed Description:
This CHOICES-TEEN intervention study will use a Phase II Behavioral Treatment Trial to employ a single blind randomized design with an attention control AC group to assess the efficacy of the CHOICES-TEEN intervention Young women 14-19 years of age entering the Harris County Juvenile Probation HCJP systems probation and field diversion and community probation program will be eligible for screening into the study The investigators anticipate recruiting N435 with 92 retention based on prior experience yielding a total sample size of N400 stratified by program with 200 randomized to the CHOICES-TEEN intervention plus Standard Care CT or the Attention only group AC using urn randomization Both groups will be assessed at 3- 6- and 9-month follow up Eligibility will be determined based on the following inclusionexclusion information This efficacy trial will 1 Test the efficacy of CHOICES-TEEN CT compared with attentional control AC on reducing the risk of substance-exposed pregnancy SEP and HIVSTI among high-risk female youth involved with the juvenile justice system by reducing alcohol use increasing marijuana cessation reducing pregnancy risk and increasing condom use 2 Test the efficacy of CT compared to an attentional control condition in increasing cognitive self-regulation abilities 3 Test proposed intervention mediatorsmechanisms of action for CT overall and by raceethnicity and 4 Test the moderating effect of initial readiness to change on risk of SEP and risk of HIVSTI
Female adolescents between the ages of 14-19 will be recruited for eligibility screening from the aforementioned community probation program Voluntarily referred youth will be screened for eligibility in the study after obtaining parental permission and youth assent All youth enrolled in the study must be identified as being at risk for substance-exposed pregnancy and HIVSTI Eligible youth who provide written informed consent and parents who provide written permission will then be randomized to the CHOICES-TEEN intervention or the Attentional Control Condition
The investigators anticipate recruiting N435 with 92 retention based on prior experience with similar studies yielding a final sample size for analyses of N400 Randomization stratified by program will result in n200 participants per condition with participants clustered within k4 forensic programs Investigators assume a conservative ICC 020 due to clustering Absolute risk reductions in risk of SEP range from 148 to 251 based on Project CHOICES Project CHOICES Plus and our pilot CHOICES-TEEN For the purposes of sample size justification investigators will assume N435 randomized in 11 fashion minimum 400 completers stratified by program and ICC 020 and a conservative estimate of an ARR15 for reduced risk of SEP and HIVSTI Finally investigators stipulate that if the posterior probability that there is an effect of treatment Odd Ratio10 is greater than 075 and that the median treatment effect estimate exceeds an Odds Ratio15 this constitutes sufficient evidence to warrant subsequent investigation M1000 Monte Carlo simulations using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 819 of the time
Data analyses The data analytic strategy will use generalized linear mixed and structural equation modeling SAS 94 R v 34 Stanv 217 and MPlus v 83 for both continuous and discrete outcomes All analyses will be conducted on an intention-to-treat basis To address missingness Bayesian approaches will implement joint modeling of observed outcomes and the missing data which is robust to ignorable missingness ie MCAR and MAR Sensitivity analyses will evaluate robustness of analytic conclusions to missing data Non-ignorable missing data patterns ie MNAR will be addressed through pattern-mixture modeling methodsSpecification of diffuse neutral priors will reflect the initial uncertainty regarding effect sizes For all generalized linear mixed models priors for regression coefficients will be specified as Normal µ0 σ21 x 106 for non-normal outcomes this refers to the prior for the coefficient within the link function level one error variances will be specified as Inverse Gamma shape0001 scale0001 Choice of prior distribution for level two variances will follow Gelmans recommendations Bayesian Structural Equation Modeling BSEM prior specification will adapt recommendations from Muthén and Asparouhov 230 Priors for the comparison of proportions will be specified as Beta α05 β05 Similar procedures will be used in secondary analyses to investigate subgroups of youth using specific substances ie alcohol and marijuana as well as intervention effects as a function of baseline readiness to change as a potential moderator Mediational modeling will examine the degree to which putative mechanisms of behavioral change transmit the effects of the intervention on the specified outcomes BSEM will investigate mediation of treatment effects due to CT on SEP and HIVSTI risk at 9 months by hypothesized mechanisms processes of change cognitive self-regulation and confidence and temptation measured at 3 months utilizing MPlus v 83 Examination of the posterior distribution of the indirect effects will evaluate the probability that mediational effects exist
Specific Data Analyses - Hypothesis 1 CT compared to Attentional Control AC AC will be associated with reduced risk of SEP and HIVSTI at 9-months post intake The primary outcome is reduced risk of SEP and HIVSTI at 9 months however at each time point 3- 6- and 9-month multilevel logistic models will evaluate the risk of SEP and HIVSTI as a function of treatment condition while addressing clustering due to forensic program assignment At each time point generalized linear multilevel models will evaluate the presenceabsence of risk drinking presenceabsence of marijuana use presenceabsence of vaginal intercourse without effective contraception and presenceabsence of vaginal or anal intercourse without condom use as a function of treatment condition while addressing clustering due to forensic program assignment
Hypothesis 2 Compared to AC CT will improve cognitive self-regulation abilities at 3- 6- and 9-month post intake as measured by self-report self-regulation measures At each time point 3- and 9-month generalized multilevel linear models will evaluate self-regulation as a function of treatment condition while addressing clustering due to forensic program assignment
Hypothesis 3 The processes of change confidence and temptation and cognitive self- regulation for each risk behavior at 3-months will mediate the effect of treatment on SEP risk and HIVSTI risk at 9-months post intake for CT Multilevel Bayesian structural equation modeling M-BSEM will evaluate the degree to which processes of change cognitive self-regulation confidence and temptation measured at 3 months follow-up mediate the effect of treatment on SEP and HIVSTI risk at 9 month follow-up Multilevel elements will address clustering as a function of forensic program assignment Multigroup analyses testing the mediation models will find invariance between Non-Hispanic Black Hispanic and Non-Hispanic White
Hypothesis 4 Female youth with low baseline readiness to change risk behavior will have less risk of SEP and HIVSTI at 3- 6- and 9-months post intake in the CT intervention condition designed to increase motivation and goal striving than female youth with low baseline readiness to change risk behavior in the AC condition At each time point 3- 6- and 9-month multilevel logistic models will evaluate the risk of SEP and HIVSTI as a function of treatment condition baseline readiness and the interaction of treatment and baseline readiness These models will use the approach advocated by Simon and Dixon
Sample Size The investigators anticipate recruiting N435 with 92 retention based on our experience with Project CHOICES CHOICES Plus and CP-T yielding a final sample size for analyses of N400 Randomization stratified by program will result in n200 participants per condition with participants clustered within k4 forensic program assignments Investigators assume a conservative ICC 020 due to clustering Absolute risk reductions in risk of SEP range from 148 to 251 based on Project CHOICES Project CHOICES Plus and our pilot CHOICES-TEEN For the purposes of sample size justification investigators will assume N435 randomized in 11 fashion minimum 400 completers stratified by program and ICC 020 and a conservative estimate of an ARR15 for reduced risk of SEP and HIVSTI Finally investigators stipulate that if the posterior probability that there is an effect of treatment Odd Ratio10 is greater than 075 and that the median treatment effect estimate exceeds an Odds Ratio15 this constitutes sufficient evidence to warrant subsequent investigation M1000 Monte Carlo simulations using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 819 of the time
Female adolescents between the ages of 14-19 will be recruited for eligibility screening from the aforementioned community probation program Voluntarily referred youth will be screened for eligibility in the study after obtaining parental permission and youth assent All youth enrolled in the study must be identified as being at risk for substance-exposed pregnancy and HIVSTI Eligible youth who provide written informed consent and parents who provide written permission will then be randomized to the CHOICES-TEEN intervention or the Attentional Control Condition
The investigators anticipate recruiting N435 with 92 retention based on prior experience with similar studies yielding a final sample size for analyses of N400 Randomization stratified by program will result in n200 participants per condition with participants clustered within k4 forensic programs Investigators assume a conservative ICC 020 due to clustering Absolute risk reductions in risk of SEP range from 148 to 251 based on Project CHOICES Project CHOICES Plus and our pilot CHOICES-TEEN For the purposes of sample size justification investigators will assume N435 randomized in 11 fashion minimum 400 completers stratified by program and ICC 020 and a conservative estimate of an ARR15 for reduced risk of SEP and HIVSTI Finally investigators stipulate that if the posterior probability that there is an effect of treatment Odd Ratio10 is greater than 075 and that the median treatment effect estimate exceeds an Odds Ratio15 this constitutes sufficient evidence to warrant subsequent investigation M1000 Monte Carlo simulations using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 819 of the time
Data analyses The data analytic strategy will use generalized linear mixed and structural equation modeling SAS 94 R v 34 Stanv 217 and MPlus v 83 for both continuous and discrete outcomes All analyses will be conducted on an intention-to-treat basis To address missingness Bayesian approaches will implement joint modeling of observed outcomes and the missing data which is robust to ignorable missingness ie MCAR and MAR Sensitivity analyses will evaluate robustness of analytic conclusions to missing data Non-ignorable missing data patterns ie MNAR will be addressed through pattern-mixture modeling methodsSpecification of diffuse neutral priors will reflect the initial uncertainty regarding effect sizes For all generalized linear mixed models priors for regression coefficients will be specified as Normal µ0 σ21 x 106 for non-normal outcomes this refers to the prior for the coefficient within the link function level one error variances will be specified as Inverse Gamma shape0001 scale0001 Choice of prior distribution for level two variances will follow Gelmans recommendations Bayesian Structural Equation Modeling BSEM prior specification will adapt recommendations from Muthén and Asparouhov 230 Priors for the comparison of proportions will be specified as Beta α05 β05 Similar procedures will be used in secondary analyses to investigate subgroups of youth using specific substances ie alcohol and marijuana as well as intervention effects as a function of baseline readiness to change as a potential moderator Mediational modeling will examine the degree to which putative mechanisms of behavioral change transmit the effects of the intervention on the specified outcomes BSEM will investigate mediation of treatment effects due to CT on SEP and HIVSTI risk at 9 months by hypothesized mechanisms processes of change cognitive self-regulation and confidence and temptation measured at 3 months utilizing MPlus v 83 Examination of the posterior distribution of the indirect effects will evaluate the probability that mediational effects exist
Specific Data Analyses - Hypothesis 1 CT compared to Attentional Control AC AC will be associated with reduced risk of SEP and HIVSTI at 9-months post intake The primary outcome is reduced risk of SEP and HIVSTI at 9 months however at each time point 3- 6- and 9-month multilevel logistic models will evaluate the risk of SEP and HIVSTI as a function of treatment condition while addressing clustering due to forensic program assignment At each time point generalized linear multilevel models will evaluate the presenceabsence of risk drinking presenceabsence of marijuana use presenceabsence of vaginal intercourse without effective contraception and presenceabsence of vaginal or anal intercourse without condom use as a function of treatment condition while addressing clustering due to forensic program assignment
Hypothesis 2 Compared to AC CT will improve cognitive self-regulation abilities at 3- 6- and 9-month post intake as measured by self-report self-regulation measures At each time point 3- and 9-month generalized multilevel linear models will evaluate self-regulation as a function of treatment condition while addressing clustering due to forensic program assignment
Hypothesis 3 The processes of change confidence and temptation and cognitive self- regulation for each risk behavior at 3-months will mediate the effect of treatment on SEP risk and HIVSTI risk at 9-months post intake for CT Multilevel Bayesian structural equation modeling M-BSEM will evaluate the degree to which processes of change cognitive self-regulation confidence and temptation measured at 3 months follow-up mediate the effect of treatment on SEP and HIVSTI risk at 9 month follow-up Multilevel elements will address clustering as a function of forensic program assignment Multigroup analyses testing the mediation models will find invariance between Non-Hispanic Black Hispanic and Non-Hispanic White
Hypothesis 4 Female youth with low baseline readiness to change risk behavior will have less risk of SEP and HIVSTI at 3- 6- and 9-months post intake in the CT intervention condition designed to increase motivation and goal striving than female youth with low baseline readiness to change risk behavior in the AC condition At each time point 3- 6- and 9-month multilevel logistic models will evaluate the risk of SEP and HIVSTI as a function of treatment condition baseline readiness and the interaction of treatment and baseline readiness These models will use the approach advocated by Simon and Dixon
Sample Size The investigators anticipate recruiting N435 with 92 retention based on our experience with Project CHOICES CHOICES Plus and CP-T yielding a final sample size for analyses of N400 Randomization stratified by program will result in n200 participants per condition with participants clustered within k4 forensic program assignments Investigators assume a conservative ICC 020 due to clustering Absolute risk reductions in risk of SEP range from 148 to 251 based on Project CHOICES Project CHOICES Plus and our pilot CHOICES-TEEN For the purposes of sample size justification investigators will assume N435 randomized in 11 fashion minimum 400 completers stratified by program and ICC 020 and a conservative estimate of an ARR15 for reduced risk of SEP and HIVSTI Finally investigators stipulate that if the posterior probability that there is an effect of treatment Odd Ratio10 is greater than 075 and that the median treatment effect estimate exceeds an Odds Ratio15 this constitutes sufficient evidence to warrant subsequent investigation M1000 Monte Carlo simulations using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 819 of the time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None