Clinical trial NCT05405972: A Behavioral Intervention With Foster Families
Official title: Effects of a Behavioral Intervention With Foster Families: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Relationship
Sibling Relations
Behavior, Social
Keywords: Randomized controlled trial
Behavioral Intervention
Sibling
Foster Care
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 95
Sex: ALL
Minimum age (years): 7
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employed a randomized control trial design of a behavioral intervention with foster families caring for a CDFC as well as a permanent child in the home. The intervention tested is self-paced and delivered via technology to include foster families in rural and underserved locations. Behavioral changes of caregivers and children in the home were predicted to improve family functioning and facilitate healing from relationship-based trauma and its associated symptoms. Stratified randomization was used to assign participants into the experimental or control group. Blinding of the two groups to participants was not done (participants knew whether or not they received the video intervention). However, the team blinded the statistical analysis to group with the use of a statistician. Families assigned to the control did have the opportunity to participate in the intervention post-data collection and analysis and outside of the research protocol.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate a behavioral intervention with foster families.

Detailed description: Study Aims: This study aims to investigate a technology-delivered family (sibling inclusive) intervention. Focus is on increasing family hardiness and preparation to care for children with disabilities and special needs in foster care. Three aims include: (1) establish the feasibility of the technology-based, family-centered intervention (2) explore in a preliminary manner the effects of the intervention on stress and relational quality outcomes among family member participants, and (3) an exploratory aim to determine feasibility and preliminary efficacy of the intervention on diurnal salivary cortisol levels within the foster family population.

Methods: This study employs a randomized control trial design of a behavioral intervention with both a control and experimental group. The intervention tested was created in partnership and adapted from the Connected Family Series (CFS) by psychologists at the Karyn Purvis Institute of Childhood Development and is called the Connected Family Series - For Foster Families (CFS-FF). Adaptation was needed as the original intervention was geared toward adoptive families and excluded foster families. The CFS-FF also needed content specific to fostering children with special needs. Stress and relational quality outcomes among members will be measured using the concepts of family hardiness, preparedness, and relationship development through a self-report questionnaire which include the Family Hardiness Index (FHI), the Integrating Foster Children (IFC) subscale from the Casey Foster Applicant Inventory (CFAI), and the Sibling Inventory of Behavior (SIB), respectively. Participation in the study spanned three to four months; one month for recruitment and collection of baseline data, one month for the intervention, and one-month post-intervention data collection. Exploratory aim 3 will be achieved by an objective indicator of stress-related biology, saliva diurnal cortisol rhythm, before and after completion of the intervention.

Eligibility criteria: Inclusion Criteria:

1. licensed foster families
2. must have at least one permanent child (biological or adopted) living in the home before the foster or newly adopted child entered the home
3. at least one foster or foster-to-adopt child placed in the home
4. all participants other than the foster or foster-to-adopt child must be proficient in English

Exclusion Criteria:

1. Non-English speaking
2. No permanent sibling between the ages of 7 at 17
3. No current foster placement living in the home
4. Designated as a group home
5. Greater than six children living in the home

Primary outcomes:
measure: Family Hardiness Index
timeFrame: Before intervention, up to 2 week
Secondary outcomes:
measure: Sibling Inventory of Behavior
timeFrame: Before intervention, up to 2 weeks
Other outcomes:
measure: Family Hardiness Index
timeFrame: After intervention, up to 3 months
measure: Sibling Inventory of Behavior
timeFrame: After intervention, up to 3 months
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Christine Platt, DNP/PhD
role: PRINCIPAL_INVESTIGATOR
References: