Study of an Online Program to Help Parents Talk With Thei... | NCT06408818

ID	Type	Description	Link
5R21HD108440-02	U.S. NIH Grant/Contract		View source

Study of an Online Program to Help Parents Talk With Thei... | NCT06408818 | Trialant

Sponsor/Collaborators Module

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Program: Media Aware Parent -Tween	Experimental	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.	Behavioral: Media Aware Parent - Tween
Active Control Resource	Active Comparator	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.	Behavioral: Active Control Resource

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Media Aware Parent - Tween	Behavioral	Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Pretest in Child Report of Frequency of Parent-child Communication	Child will respond to questions about the frequency with which their parent has talked with them about 12 topics related to prepubescent health on a Likert-type scale [1 = Never; 2 = A little; 3 = A lot]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.	Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
Change From Pretest in Parent Report of Frequency of Parent-child Communication	Parent will respond to questions about the frequency with which they have talked with their child about 12 topics related to prepubescent health on a Likert-type scale [1 = Never; 2 = A little; 3 = A lot]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.	Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
Change From Pretest in Child Report of General Parent-child Communication Quality	Child will indicate the extent to which they agree with nine statements about communication with their parent on a Likert-type scale [1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.	Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)
Change From Pretest in Parent Report of General Parent-child Communication Quality	Parent will indicate the extent to which they agree with nine statements about communication with their child on a Likert-type scale [1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.	Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
innovation Research and Training		Durham	North Carolina	27713	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 22, 2024

Arm/Group Information

ID	Title	Description
BG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
BG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000196 BG001194 BG002390

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

One parent from each condition was missing data on parent age.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0002.18± 0.05 OG0012.20± 0.04

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.69		Mean Difference (Final Values)	-0.02	Standard Error of the Mean	0.06	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Primary

Change From Pretest in Parent Report of Frequency of Parent-child Communication

Parent will respond to questions about the frequency with which they have talked with their child about 12 topics related to prepubescent health on a Likert-type scale [1 = Never; 2 = A little; 3 = A lot]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of General Parent-child Communication Quality

Child will indicate the extent to which they agree with nine statements about communication with their parent on a Likert-type scale [1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Parent Report of General Parent-child Communication Quality

Parent will indicate the extent to which they agree with nine statements about communication with their child on a Likert-type scale [1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of Active Parental Media Mediation

Child's perception of parent's use of active media mediation will be assessed using two items (e.g., "How often does your parent tell you what they see in media is different than real life?"). Participants will rate items on a 5-point Likert scale [1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Parent Report of Active Parental Media Mediation

Parents' use of active media mediation will be assessed using two items (e.g., "How often do you tell your child what they see in media is different than real life?"). Participants will rate items on a 5-point Likert scale [1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of Parental Restrictive Media Mediation

Child's perception of parent's use of restrictive media mediation will be assessed using one item (e.g., "How often does your parent limit the amount of your screen time (watching shows, going online, playing video games, or using social media)?"). Participants will rate items on a 5-point Likert scale [1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often]. Higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Parent Report of Parental Restrictive Media Mediation

Parent's use of restrictive media mediation will be assessed using one item (e.g., "How often do you limit the amount of your child's screen time (watching shows, going online, playing video games, or using social media)?"). Participants will rate items on a 5-point Likert scale [1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = very often].

Higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of Awareness of Family Media Rules

Child will indicate on one item whether their family has rules about media use. Response options are "yes (1)," "no (0)," and "unsure (2)". Yes (1) indicates a more favorable outcome.

This analysis was conducted using multiple imputed data. Therefore, the percentage values will not yield a whole participant because results are pooled between 50 imputations.

Posted

Number

percentage of participants with "1"

Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Parent Report of Awareness of Family Media Rules

Parent will indicate on one item whether their family has rules about media use. Response options are "yes (1)," "no (0)," and "unsure (2)". Yes (1) indicates a more favorable outcome.

This analysis was conducted using multiple imputed data. Therefore, the percentage values will not yield a whole participant because results are pooled between 50 imputations.

Posted

Number

percentage of participants w/ "1"

Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of Acceptance of Gender Stereotypical Roles

Child will respond to the 7 items to indicate their agreement with statements about gender using a 5-point Likert scale (1 = "disagree a lot" to 5 = "agree a lot"). Reponses on items are averaged, and higher scores indicate a less favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of Attitudes Toward Puberty

Child will respond to one item (i.e., "I like the fact that I am becoming a woman/man") on a 4-point scale from 1 = disagree a lot to 4 = Agree a lot to assess participants' attitudes towards puberty. Higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Primary

Change From Pretest in Child Report of Body-esteem

Child will respond to four statements about how they feel about their body (e.g., I'm proud of my body) on a 5-point scale [1 = Never; 2 = Seldom; 3 = Sometimes; 4 = Often; 5 =Always]. Reponses on items are averaged, and higher scores indicate a more favorable outcome.

Posted

Least Squares Mean

Standard Error

score on a scale

Pretest (at baseline) and Posttest (about four weeks after pretest questionnaire completion)

ID	Title	Description
OG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.
OG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intervention Program: Media Aware Parent -Tween	Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media.	0	196	0	196	0	196
EG001	Active Control Resource	Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships.	0	194	0	194	0	194

Child

- ParticipantsBG00098
- ParticipantsBG00197
- ParticipantsBG002195

Title	Measurements
Hispanic or Latino	BG00021 BG00120 BG00241
Not Hispanic or Latino	BG00077 BG00177 BG002154
Unknown or Not Reported	BG0000 BG0010 BG0020

Title	Measurements
American Indian or Alaska Native	BG0003 BG0011 BG0024
Asian	BG0005 BG00110 BG00215
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG00016 BG00122 BG00238
White	BG00061 BG00157 BG002118
More than one race	BG0003 BG0011 BG0024
Unknown or Not Reported	BG00010 BG0016 BG00216

Children

- ParticipantsBG00098
- ParticipantsBG00197
- ParticipantsBG002195

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 BG0023
Asian	BG0003 BG0017 BG00210
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG00018 BG00120 BG00238
White	BG00055 BG00151 BG002106
More than one race	BG00011 BG00112 BG00223
Unknown or Not Reported	BG0009 BG0016 BG00215

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.33		Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.05	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.46		Mean Difference (Final Values)	-0.05	Standard Error of the Mean	0.07	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.46		Mean Difference (Final Values)	-0.04	Standard Error of the Mean	0.06	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.20		Mean Difference (Final Values)	-0.22	Standard Error of the Mean	0.17	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.22		Mean Difference (Final Values)	0.13	Standard Error of the Mean	0.11	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.48		Mean Difference (Final Values)	0.13	Standard Error of the Mean	0.19	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.69		Mean Difference (Final Values)	0.06	Standard Error of the Mean	0.16	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.22		Mean Difference (Final Values)	-0.78	Standard Error of the Mean	0.63	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.57		Slope	-0.45	Standard Error of the Mean	0.79	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.42		Mean Difference (Final Values)	0.08	Standard Error of the Mean	0.10	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.45		Mean Difference (Final Values)	-0.10	Standard Error of the Mean	0.13	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Linear		0.39		Mean Difference (Final Values)	-0.10	Standard Error of the Mean	0.12	2-Sided								Equivalence	To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.