Innovative Family Prevention With Latino Siblings in Disadvantaged Settings (SIBS)

October 24, 2025 updated by: Adriana Umaña-Taylor, Harvard University
The current study is a randomized intervention trial that tests the efficacy of a family-focused sibling relationship promotion program. The study includes a treatment group and a contact-equivalent attention control condition with 288 sibling dyads and data collection with target parents, target sibling dyads, and teachers at three time points (pre-test, post-test, and 18-month follow-up). Data will be collected using a three-cohort design with 96 families in each of the three cohorts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed project tests the efficacy of a family-focused program. This innovative program is focused on sibling relationships and parenting of siblings as synergistic targets of change to promote positive interpersonal family dynamics and parent and youth psychosocial and behavioral health and well-being. This translational effort builds on strong theoretical and empirical premises including a successful pilot study (ASU SIBS Program). Using a rigorous design and measurement, aims are to: (a) test the efficacy of SIBS, delivered via 12 weekly afterschool sibling sessions and 3 family nights in the familiar elementary school setting, versus a contact-equivalent attention control condition. Mexican-origin sibling dyads (5th graders and younger siblings; N = 288 dyads) and their parents will be recruited from economically disadvantaged elementary schools and randomly assigned within school to intervention or contact-equivalent attention control conditions. Assessments will be conducted at pre-test, post-test, and 18-month follow-up. Program effects will be tested on primary and secondary outcomes, including sibling relationship quality (i.e., warmth and negativity), sibling relationship skills, children's efficacy (social, emotional), children's internalizing symptoms, parents' stress and depressive symptoms, parent-child warmth and conflict, and family cohesion. Findings will advance prevention science by identifying an efficacious program that capitalizes on cultural assets to promote positive family dynamics and psychosocial well-being among Latinos, including by incorporating daily measurements of intervention targets (sibling relationship skills) to identify mechanisms underlying program effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85287
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Target child has to be a 5th grader
  • Target child has to be of Latino/Hispanic heritage
  • Target child has to have a younger sibling enrolled in the same school in the 1st through 4th grade
  • Target child and younger sibling have to be enrolled students in a participating elementary school.

Exclusion Criteria:

- Enrollment in a self-contained special education setting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SIBS Program
The program condition includes 12 weekly 90-minute afterschool group sessions for siblings. Sessions are structured as psycho-educational groups and include social interactional activities, role-playing, discussion, and didactic presentation. The focus is on sibling relationship skills, cognitions, and activities. During a total of 3 family nights, parents attend with their children. Part of the family night session involves parents and children together. Another part of the session involves parents being separated from children. Family Nights promote parents' understanding of sibling relationships, review concepts, provide strategies for parental support of siblings, and teach parents skills for dealing with sibling problems. Family Nights include dinner and last 2 hours.
Behavioral: SIBS Program
Universal prevention program promoting positive sibling and family relationships conducted in an afterschool setting
Placebo Comparator: Contact-Equivalent Attention Control
The Contact-Equivalent Attention Control condition includes 12 weekly 90-minute afterschool group sessions for siblings led by two co-leaders. Students work on educational games and activities. Groups begin with an icebreaker and continue with games and projects. This condition also includes 3 family nights, where parents attend with their children. Activities of the Family Nights include children showing their parents the activities they have been engaging in during the sessions. Family Nights include dinner and last 2 hours. Part of the family night session involves parents and children together. Another part of the session involves parents being separated from children; during this part, parents will break out with one group leader, and siblings will work with the other group leader.
Behavioral: Control
Contact-equivalent attention control program in which students play educational games

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parenting of Siblings Measure
Time Frame: 16 weeks
The measure assesses parents' perceptions of three constructs: Parents' positive guidance, authoritarian control, and involvement (McHale et al., 2000; Updegraff et al., 2016). For each subscale, scores range from 1 to 5. Higher subscale scores indicate more positive guidance (i.e., better outcome), higher involvement (i.e., better outcome), and higher authoritarian control (i.e., worse outcome). Subscales are not combined into a total score.
16 weeks
Sibling Prosocial Behavior
Time Frame: 16 weeks

The measure assesses parents' perceptions of one construct: Parents' ratings of children's supportive and prosocial behaviors (Stormshak, Bellanti, & Bierman, 1996; Updegraff et al., 2016).

Scores range from 1 to 6. Higher scores indicate parents' perceptions of target child's more prosocial behaviors toward their sibling (i.e., better outcome).
16 weeks
Sibling Intimacy
Time Frame: 16 weeks
The measure assesses siblings' ratings of intimacy/emotional support (Blyth & Foster-Clark, 1987). Scores range from 1 to 5. Higher scores indicate target child's perceptions of higher sibling intimacy and closeness (i.e., better outcome).
16 weeks
Sibling Relationship Inventory: Negativity Subscale
Time Frame: 16 weeks
The measure assesses parents' ratings of sibling conflict and negativity (Stocker & McHale, 1992). Scores range from 1 to 5. Higher scores indicate parents' perceptions of target child's greater negativity toward their sibling (i.e., worse outcome).
16 weeks
Sibling Relationship Inventory: Negativity Subscale
Time Frame: 16 weeks
The measure assesses children's ratings of sibling conflict and negativity (Furman & Buhrmester, 1985). Scores range from 1 to 5. Higher scores indicate target child's perceptions of higher sibling conflict and negativity (i.e., worse outcome).
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-efficacy Measure
Time Frame: 16 weeks
This measure assesses children's ratings of two constructs: social self-efficacy and emotional self-efficacy (Muris, 2001). For each subscale, scores range from 1 to 5. Higher subscale scores indicate greater social self-efficacy (i.e., better outcome) and greater emotional self-efficacy (i.e., better outcome). Subscales are not combined into a total score.
16 weeks
Children's Depression Inventory
Time Frame: 16 weeks
This measure assesses children's ratings of their depressive symptoms (Kovacs, 1985). Items are scored on a scale from 0 to 2, and higher scores indicate greater depressive symptoms (i.e., worse outcome). If mean scores are used, scores range from 0 to 2. If sum scores are used, scores range from 0 to 52.
16 weeks
Behavior Problem Index
Time Frame: 16 weeks
This measure assesses parents' perceptions of children's social emotional functioning in 6 domains (i.e., antisocial, anxious/depressed, headstrong, hyperactive, dependency, peer conflict; Peterson & Zill, 1986). For all scales, items are scored on a scale from 1 to 3. For each subcale, higher scores indicate higher problem behavior in the domain (i.e., worse outcome). Mean scores are created for each subscale, and a total mean score is created across all domains - in all cases, higher scores indicate worse outcomes.
16 weeks
Center for Epidemiological Depression Scale
Time Frame: 16 weeks
The CES-D (Radloff, 1977) assesses parents' depressive symptoms. Items are scored on a scale from 0 to 3, and higher scores indicate greater depressive symptoms (i.e., worse outcome). No subscales are created. If mean scores are used, scores range from 0 to 3. If sum scores are used, scores range from 0 to 60.
16 weeks
Parenting Stress Index
Time Frame: 16 weeks
This measure assesses parents' perceptions of parental stress and includes two subscales: parental distress and dysfunctional interaction (Abidin, 1995). Items for each subscale are scored on a scale from 1 to 5. Mean scores can be created for each subscale, and higher scores indicate higher levels of distress (i.e., worse outcome) and higher dysfunctional interaction (i.e., worse outcome). A total scale score can be created across all items and higher scores indicate higher parenting stress (i.e., worse outcome).
16 weeks
Children's Reports of Parental Behavior Inventory - Parent-Child Warmth
Time Frame: 16 weeks
This measure assesses parent and child's report of parent-child warmth (Schaefer, 1965). Items are scored on a scale of 1 to 5. Items are average and higher scores indicate greater perceptions of parent-child warmth (i.e., better outcome).
16 weeks
Children's Reports of Parental Behavior Inventory - Harsh Discipline
Time Frame: 16 weeks
This measure assesses parent's reports of harsh discipline (Schaefer, 1965). Items are scored on a scale of 1 to 5. Items are average and higher scores indicate greater perceptions of harsh discipline (i.e., worse outcome).
16 weeks
Parent-Child Conflict measure
Time Frame: 16 weeks
This measure assesses parents' perceptions of parent-child conflict (Smetana, 1988). Items are scored on a scale from 1 to 6. Average scores are created and higher values indicate greater parent-child conflict (i.e., worse outcome).
16 weeks
Family Adaptability and Cohesion Evaluation Scales II
Time Frame: 16 weeks
This measure assesses parents' perceptions of family cohesion (Olson, Portner, & Bell, 1982). Items are scored on a scale from 1 to 5. An average score is created and higher scores indicate greater family cohesion (i.e., better outcome).
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adriana J Umana-Taylor, PhD, Harvard University
  • Principal Investigator: Kimberly A Updegraff, PhD, Arizona State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SITE18-0185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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