Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD

Официальное название

Families Moving Forward Bridges: An Early Intervention Enhancement for Infants and Toddlers With Prenatal Alcohol Exposure With or At-risk for Fetal Alcohol Spectrum Disorders

Обзор

This is an unblinded, feasibility study of an adapted positive parenting intervention to be carried out in a small sample (n=12 dyads) of young children with FASD and their primary caregiver in King County, WA.

Подробное описание

This is an initial feasibility study to examine Families Moving Forward Bridges (FMF Bridges), an FASD-informed early intervention designed to meet the specific needs of young children 6-36 months with prenatal alcohol exposure (PAE) or FASD and their caregivers. FMF Bridges was developed by this research team and is adapted from a scientifically-validated positive parenting intervention (Families Moving Forward) shown to be efficacious with preschool and school-aged children affected by PAE or FASD. FMF Bridges merges key components of FASD-informed care with family-centered and relationship-based early intervention practices and is designed to be delivered in community-based early intervention programs. The FMF Bridges early intervention needs to be tested with children and families in the community-based early intervention settings for which it was designed. The study team plans to evaluate the feasibility of FMF Bridges in a small community trial. the team will partner with an early intervention program that has a high population of children with prenatal alcohol exposure. EI providers will be trained as FMF Bridges Specialists and deliver the intervention to a total of 12 dyads (young child and their primary caregiver). Dyads will receive ten 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week) from community EI providers trained as FMF Bridges Specialists.

Primary Aim 1: Examine the feasibility of implementing the FMF Bridges early intervention in a community early intervention setting.

The study will focus on answering the questions: 1) Is it practical to implement the FMF Bridge intervention in a community EI setting? 2) Can the intervention be implemented with fidelity? 3) Is the intervention acceptable to providers and caregivers? and 4) What refinements might be needed to improve the feasibility of implementation?

Вмешательства

• Поведенческое Families Moving Forward Bridges
  Ten, 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week)

Первичные конечные точки

• Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT) [Срок оценки: From enrollment to the end of intervention 3-5 months]
• Parenting Interactions with Children - Checklist of Observations Linked to Outcomes (PICCOLO) 86 [Срок оценки: From enrollment to the end of intervention 3-5 months]
• Family Outcomes Survey - Revised (FOS-R) [Срок оценки: From enrollment to the end of intervention 3-5 months]
• Healthy Families Parenting Inventory (HFPI) [Срок оценки: From enrollment to the end of intervention 3-5 months]

Критерии участия

Критерии включения

• Child inclusion criteria: Infants and toddlers 6-36 months of age, any gender, any race/ethnicity, who:

• have confirmed PAE as ascertained by the standard child development center intake procedures;
• and 2) qualify for IDEA Part C EI services based on presence of a developmental delay (>25% in one or more areas of development) or therapist/provider informed clinical opinion.

Caregiver inclusion criteria:

• biological, foster, adoptive, or other legal guardian;
• age 18 or older;
• any gender.

Критерии исключения

• Child exclusion criteria:

• child has lived with current caregiver for less than 30% of chronological age or there is a planned change in caregiver placement or move out of King County within 3 months of intake;
• child has a medical or congenital/genetic condition that would severely limit participation in assessments, such as a significant visual or hearing impairment, degenerative muscle condition, or uncontrolled seizures;
• multiple birth;
• child currently receives inpatient medical care (e.g., NICU) or has a medical condition requiring a planned inpatient hospitalization or surgical intervention (e.g., heart condition);
• child diagnosis of a known genetic or non-FASD neurodevelopmental condition (e.g., Down syndrome, autism spectrum disorder).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Wonderland Child Development Center — Shoreline

Идентификаторы

NCT: NCT06935461 · STUDY00020599 · 1R61AA031695-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗