Clinical trial NCT03706014: Innovative Family Prevention With Latino Siblings in Disadvantaged Settings
Official title: Innovative Family Prevention With Latino Siblings in Disadvantaged Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Promotion of Positive Sibling Relationships
Keywords: siblings
family
Latinos
social emotional competencies
parenting
middle childhood
late childhood
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 270
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial involving a contact-equivalent control group
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Parenting of Siblings Measure
timeFrame: 16 weeks
measure: Sibling Prosocial Behavior
timeFrame: 16 weeks
measure: Sibling Intimacy
timeFrame: 16 weeks
measure: Sibling Relationship Inventory: Negativity Subscale
timeFrame: 16 weeks
measure: Sibling Relationship Inventory: Negativity Subscale
timeFrame: 16 weeks
Secondary outcomes:
measure: Self-efficacy Measure
timeFrame: 16 weeks
measure: Children's Depression Inventory
timeFrame: 16 weeks
measure: Behavior Problem Index
timeFrame: 16 weeks
measure: Center for Epidemiological Depression Scale
timeFrame: 16 weeks
measure: Parenting Stress Index
timeFrame: 16 weeks
measure: Children's Reports of Parental Behavior Inventory - Parent-Child Warmth
timeFrame: 16 weeks
measure: Children's Reports of Parental Behavior Inventory - Harsh Discipline
timeFrame: 16 weeks
measure: Parent-Child Conflict measure
timeFrame: 16 weeks
measure: Family Adaptability and Cohesion Evaluation Scales II
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Harvard University
name: Adriana J Umana-Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University
name: Kimberly A Updegraff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.