Family STEPS: Family Check-Up+
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Family Check Up.
- Who it may be relevant to
- Registry conditions: Child Behavior Problem. Basic parameters: 2 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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
Primary outcome measures
- Recruitment Rate [Time frame: During recruitment - pre-randomization]
- Fidelity to FCU Delivery [Time frame: During Intervention- on average 3-5 weeks]
- Retention [Time frame: 3, 6, 9, and 12 months post-randomization]
- Completion of Core FCU Components [Time frame: During Intervention - on average 3-5 weeks]
- Engagement in Everyday Parenting (EDP) Sessions [Time frame: During Intervention- on average 6 sessions]
- Receipt of Navigation and Linkage Activities [Time frame: During Intervention- Up to 1 year]
- Dose of FCU Services Delivered [Time frame: During entire study period- up to 12 months]
- Timeliness of FCU Delivery [Time frame: Time of intervention- on average 3-5 weeks]
Secondary outcome measures (2)
- Child emotional/behavioural problems [Time frame: Baseline, 6-months, 12 months]
- Parenting Practices [Time frame: Baseline, 6 months, 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- McMaster University — Hamilton
Identifiers
NCT: NCT07433361 · 19754