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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03706014
Other study ID # SITE18-0185
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 29, 2018
Est. completion date August 2024

Study information

Verified date September 2023
Source Harvard University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 270
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Promotion of Positive Sibling Relationships

Intervention

Behavioral:
SIBS Program
Universal prevention program promoting positive sibling and family relationships conducted in an afterschool setting
Control
Contact-equivalent attention control program in which students play educational games

Locations

Country Name City State
United States Arizona State University Tempe Arizona

Sponsors (1)

Lead Sponsor Collaborator
Harvard University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Feinberg ME, Solmeyer AR, Hostetler ML, Sakuma KL, Jones D, McHale SM. Siblings are special: initial test of a new approach for preventing youth behavior problems. J Adolesc Health. 2013 Aug;53(2):166-73. doi: 10.1016/j.jadohealth.2012.10.004. Epub 2012 Nov 20. — View Citation

Updegraff KA, Umana-Taylor AJ, Rodriguez De Jesus SA, McHale SM, Feinberg MF, Kuo SI. Family-focused prevention with Latinos: What about sisters and brothers? J Fam Psychol. 2016 Aug;30(5):633-40. doi: 10.1037/fam0000200. Epub 2016 Apr 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Parenting of Siblings Measure 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
Primary Sibling Prosocial Behavior 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
Primary Sibling Intimacy 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
Primary Sibling Relationship Inventory: Negativity Subscale 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
Primary Sibling Relationship Inventory: Negativity Subscale 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 Self-efficacy Measure 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
Secondary Children's Depression Inventory 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
Secondary Behavior Problem Index 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
Secondary Center for Epidemiological Depression Scale 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
Secondary Parenting Stress Index 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
Secondary Children's Reports of Parental Behavior Inventory - Parent-Child Warmth 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
Secondary Children's Reports of Parental Behavior Inventory - Harsh Discipline 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
Secondary Parent-Child Conflict measure 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
Secondary Family Adaptability and Cohesion Evaluation Scales II 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