Network-Based Support to Help Community Coalition Members Choose and Use Strategies to Improve Child Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

Community coalitions bring together residents and organizations to improve child health, but they may need support to identify and put research-supported strategies into practice. This study will examine whether a program called FICAS can be delivered successfully and is useful to coalition members. FICAS uses information about relationships within a coalition to help involve people with relevant perspectives, share evidence, compare possible strategies, make decisions, and adjust support as the coalition's work develops.

Three community coalitions will participate. All three will eventually receive Catalyzing Communities, a program that provides facilitated meetings, collaborative planning, technical assistance, and funding for coalition-led action. One coalition will begin the program later, one will receive Catalyzing Communities alone, and one will receive Catalyzing Communities with FICAS. The study will help determine whether FICAS and the study procedures should be refined and tested in a larger study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Coalition focuses on child health, childhood obesity prevention, healthy eating, active living, nutrition security, policy, systems, or environmental change, or related community health priorities.

Coalition works in or serves a community experiencing socioeconomic disadvantage.

Coalition has multisector participation.

Coalition has identifiable leadership or backbone capacity to participate in the study.

Disqualifiers

Coalition is unable to participate in required study activities.

Coalition lacks a feasible membership roster or the ability to construct one with study-team assistance, or lacks an identifiable leadership contact.

Coalition is unwilling to accept randomized coalition-level assignment.

Coalition is participating in a comparable formal coalition intervention that would prevent interpretation of the study findings.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Catalyzing Communities

    Behavioral

    Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding. The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation. Activities may be delivered virtually or in person and continue across the active intervention period.

  • FICAS Implementation Intervention

    Behavioral

    FICAS is a multicomponent implementation intervention delivered as an augmentation to Catalyzing Communities. It includes five strategies: using roster and network data to strengthen committee representation and connectivity; identifying and engaging influential or bridging coalition members; progressively assembling and reviewing research, practice, community, and policy evidence; using structured criteria and deliberation to select an evidence-informed strategy; and monitoring coalition network data to guide adaptations. Components are delivered at relevant milestones across evidence review, strategy selection, and early implementation.

Treatment groups

3,300 Participants
are divided into 3 treatment groups
Group A: Delayed ControlOther 1 intervention
Group B: Positive Control: Catalyzing CommunitiesActive comparator 1 intervention
Group C: Augmented Treatment: Catalyzing Communities Plus FICASExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Participation and Reach

The number of eligible coalition members who provide informed consent and complete at least one study data-collection activity will be divided by the total number of eligible coalition members invited to participate and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater study reach.

Time frame
From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation
2

Percentage of Enrolled Participants Retained Through the Primary Endpoint

The number of participants in the baseline cohort who complete the final scheduled primary assessment will be divided by the number enrolled in the baseline cohort and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater retention.

Time frame
Baseline through intervention month 12
3

Mean Acceptability of Intervention Measure Score for FICAS

Acceptability of FICAS will be measured using the four-item Acceptability of Intervention Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived acceptability. Mean scores will be reported separately at each assessment.

Time frame
Intervention months 6, 9, and 12
4

Mean Intervention Appropriateness Measure Score for FICAS

Perceived appropriateness of FICAS will be measured using the four-item Intervention Appropriateness Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived appropriateness. Mean scores will be reported separately at each assessment.

Time frame
Intervention months 6, 9, and 12

Secondary outcomes

1

Percentage of Selected-Strategy Adoption Milestones Completed

Coalition progress will be assessed using eight prespecified milestones: naming and actively considering a candidate strategy, formally selecting a strategy, assigning implementation roles, drafting an implementation plan, securing resources or commitments, completing launch preparation, initiating the first implementation activity, and beginning early monitoring or refinement. Each completed milestone receives one point. The number completed will be divided by eight and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater progress from strategy consideration through adoption and early action.

Time frame
Intervention months 9 and 12
2

Normalized Early Implementation Readiness and Action-Initiation Score

Readiness and action initiation will be assessed using a nine-indicator study-specific rubric. Indicators address confirmation of the selected strategy, implementation leadership, assigned responsibilities, a written implementation plan, timelines and milestones, resources and supports, partner commitments, launch preparation, and initiation of the first implementation action. Each applicable indicator is scored from 0, no evidence, to 3, completed or fully documented. Scores will be summed, divided by the maximum possible score for applicable indicators, and multiplied by 100. Scores range from 0 to 100. Higher scores indicate greater implementation readiness and action initiation.

Time frame
Intervention months 9 and 12
3

Coalition Child-Health Discussion Network Density

At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion. Coalition network density will be calculated as the number of observed directed child-health discussion ties among rostered coalition members divided by the total number of possible directed ties, excluding self-ties. Scores range from 0 to 1. Higher values indicate a more densely connected coalition discussion network.

Time frame
Pre-intervention baseline and monthly through intervention month 12
4

Percentage of Child-Health Discussion Ties Connecting Different Sectors

The number of reported child-health discussion ties connecting people from different organizational or community sectors will be divided by the number of reported ties with sector information and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater cross-sector connectivity.

Time frame
Pre-intervention baseline and monthly through intervention month 12

Other outcomes

Sponsors and contacts

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University of Pittsburgh

Lead sponsor

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

Collaborator

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