Family STEPS: Family Check-Up+

Официальное название

CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+

Обзор

Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all using a pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings. The trial will enroll 300 families in Ontario, Canada. The evaluation is informed by the RE-AIM framework, with a primary emphasis on Reach and Implementation and secondary examination of Effectiveness, consistent with the objectives of a Hybrid Type II design.

Подробное описание

The overall goal of the evaluation is to assess the extent to which the target population is reached and retained in FCU+ within routine service settings. Reach will be evaluated through recruitment rates (the proportion of eligible families who consent and enroll), retention (the proportion of randomized participants completing follow-up assessments), and family-level uptake of FCU+ intervention components. Second, we aim to provide robust evidence about the implementation and effectiveness of the Family Check-Up program, in the province of Ontario, on parenting practices and functioning, and child emotional behaviour problems outcomes. The investigators will conduct a ua pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings with 300 participating caregivers to compare the Family Check-Up (FCU) to treatment as usual (TAU) . Participants will be randomly assigned to one of the two conditions using stratified (by site) block randomization. All participants will undergo screening and a baseline assessment before randomization. Once randomized, the FCU participants will begin their sessions and the TAU participants will receive a different program, or short therapy sessions. Caregivers will complete a baseline research assessment and follow-up assessments at 6- and 12-months.

Вмешательства

• Поведенческое Family Check Up
  The FCU is a brief, strengths-based and evidenced informed intervention designed to support positive parenting and child and family well-being. Phase 1 of FCU an initial interview, an assessment, and a feedback session. Motivation interviewing is incorporated into all three components. During the feedback session the providers and caregivers work together to create a list of resources based on the needs identified by the families. Providers will work to connect the families to the identified res

Первичные конечные точки

• Recruitment Rate [Срок оценки: During recruitment - pre-randomization]
• Fidelity to FCU Delivery [Срок оценки: During Intervention- on average 3-5 weeks]
• Retention [Срок оценки: 3, 6, 9, and 12 months post-randomization]
• Completion of Core FCU Components [Срок оценки: During Intervention - on average 3-5 weeks]
• Engagement in Everyday Parenting (EDP) Sessions [Срок оценки: During Intervention- on average 6 sessions]
• Receipt of Navigation and Linkage Activities [Срок оценки: During Intervention- Up to 1 year]
• Dose of FCU Services Delivered [Срок оценки: During entire study period- up to 12 months]
• Timeliness of FCU Delivery [Срок оценки: Time of intervention- on average 3-5 weeks]

Вторичные конечные точки (2)

• Child emotional/behavioural problems [Срок оценки: Baseline, 6-months, 12 months]
• Parenting Practices [Срок оценки: Baseline, 6 months, 12 months]

Критерии участия

Критерии включения

• Custodial caregiver of child is aged 2 to 6 years at time of screening.
• Families with sufficient knowledge of English needed for assessment measures.
• Caregivers capable of giving informed, written consent.
• Definition of 'at-risk' as measured by (a) or (b)as outlined below:

parental mental health problems, as indexed by a score of ≥ 13 on the K6 distress scale or; (b) Meeting pre-determined criteria for higher risk, for example, a family may be eligible for FCU if any one or more of the following are present based on the Family Needs Assessment : i) child behaviour or school-related concerns; ii) parenting difficulty or low parenting confidence; iii) Substance use causing family-level problems; or iv) three or more social or material stressors affecting parenting

Критерии исключения

• Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• McMaster University — Hamilton

Идентификаторы

NCT: NCT07433361 · 19754

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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