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

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ClinicalTrials.gov Identifier: NCT03706014
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Adriana Umaña-Taylor, Harvard University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Promotion of Positive Sibling Relationships Behavioral: SIBS Program Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial involving a contact-equivalent control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Innovative Family Prevention With Latino Siblings in Disadvantaged Settings
Actual Study Start Date : September 29, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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).


  3. 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).

  4. 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).

  5. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706014


Contacts
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Contact: Adriana J Umana-Taylor, PhD 617.384.5047 adriana_umana-taylor@gse.harvard.edu
Contact: Dean Redfearn, PhD 617.384.5047 dean_redfearn@gse.harvard.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Tempe, Arizona, United States, 85287
Contact: Kimberly Updegraff, PhD    480-965-6669    kimberly.updegraff@asu.edu   
Contact: Valerie Salcido, EdM    480.965.6978    vsalcid2@asu.edu   
Sponsors and Collaborators
Harvard University
Investigators
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Principal Investigator: Adriana J Umana-Taylor, PhD Harvard University
Principal Investigator: Kimberly A Updegraff, PhD Arizona State University
  Study Documents (Full-Text)

Documents provided by Adriana Umaña-Taylor, Harvard University:
Statistical Analysis Plan  [PDF] October 10, 2018
Study Protocol and Informed Consent Form  [PDF] October 10, 2018

Publications:
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Responsible Party: Adriana Umaña-Taylor, Professor, Harvard University
ClinicalTrials.gov Identifier: NCT03706014    
Other Study ID Numbers: 1R01HD093649 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adriana Umaña-Taylor, Harvard University:
siblings
family
Latinos
social emotional competencies
parenting
middle childhood
late childhood