- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05405972
A Behavioral Intervention With Foster Families
Effects of a Behavioral Intervention With Foster Families: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- licensed foster families
- must have at least one permanent child (biological or adopted) living in the home before the foster or newly adopted child entered the home
- at least one foster or foster-to-adopt child placed in the home
- all participants other than the foster or foster-to-adopt child must be proficient in English
Exclusion Criteria:
- Non-English speaking
- No permanent sibling between the ages of 7 at 17
- No current foster placement living in the home
- Designated as a group home
- Greater than six children living in the home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Receiving Intervention
The intervention group receives a link each week connecting them to the videos for both parents and children as well as a communicating/connecting activity. The intervention is self-paced over a 4 week period. The intervention was titled the Connected Family Series - For Foster Families (CFS-FF) (further referred to as the intervention) and was created/adapted in partnership from the Connected Family Series (CFS) by psychologists at the Karyn Purvis Institute of Childhood Development (KPICD). A letter of support from the KPICD is available in Appendix D. Adaptation was needed as the original intervention was geared toward adoptive families and excluded foster families. This process was done with the original creator (Dr. Jana Hunsley) with members of the research team and fostering community. |
A 4-week program involving videos and activities for both the parent and child in the home.
|
|
No Intervention: Control Group
Families in the control group receive no video links during the 4 week period.
Families assigned to the control do have the opportunity to participate in the intervention post-data collection and analysis and outside of the research protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family Hardiness Index
Time Frame: Before intervention, up to 2 week
|
Psychometrically validated self-report tool for family functioning.
Unabbreviated scale title: Family Hardiness Index Min Value: 0 Max Value: 60 Higher Score means better/improvement in hardiness
|
Before intervention, up to 2 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sibling Inventory of Behavior
Time Frame: Before intervention, up to 2 weeks
|
Psychometrically validated self-report tool for sibling relationships. Unabbreviated scale title: Sibling Inventory of Behavior (Positive) Min Value: 15 Max Value: 75 Higher Score means there are more positive outcomes between the siblings Unabbreviated scale title: Sibling Inventory of Behavior (Negative) Min Value: 17 Max Value: 85 Higher Score means there are more negative outcomes between the siblings |
Before intervention, up to 2 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family Hardiness Index
Time Frame: After intervention, up to 3 months
|
Psychometrically validated self-report tool for family functioning.
Unabbreviated scale title: Family Hardiness Index Min Value: 0 Max Value: 60 Higher Score means better/improvement in hardiness
|
After intervention, up to 3 months
|
|
Sibling Inventory of Behavior
Time Frame: After intervention, up to 3 months
|
Psychometrically validated self-report tool for sibling relationships. Unabbreviated scale title: Sibling Inventory of Behavior (Positive) Min Value: 15 Max Value: 75 Higher Score means there are more positive outcomes between the siblings Unabbreviated scale title: Sibling Inventory of Behavior (Negative) Min Value: 17 Max Value: 85 Higher Score means there are more negative outcomes between the siblings |
After intervention, up to 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine Platt, DNP/PhD, University of Arizona
Publications and helpful links
Helpful Links
- Bruskas, D., & Tessin, D. H. (2013). Adverse childhood experiences and psychosocial well-being of women who were in foster care as children. The Permanente Journal, 17(3), e131-e141.
- Gypen, L., Vanderfaeillie, J., De Maeyer, S., Belenger, L., & Van Holen, F. (2017). Outcomes of children who grew up in foster care: Systematic-review. Children and Youth Services Review, 76, 74-83
- Gypen, L., West, D., Van Holen, F., & Vanderfaeillie, J. (2020). Birth children of foster carers: How do they experience the foster care placement. Child and Youth Services Review 109, 104703
- Vanderfaeillie, J., Van Holen, F., Carlier, E., & Fransen, H. (2018b). Breakdown of foster care placements in Flanders: Incidence and associated factors. Eur Child Adolesc Psychiatry, 27(2), 209-220.
- Wojciak, A. S., McWey, L. M., & Waid, J. (2018). Sibling relationships of youth in foster care: A predictor of resilience. Children and Youth Services Review, 84, 247-254.
- Turney, K., & Wildeman, C. (2016). Mental and physical health of children in foster care. Pediatrics, 138(5)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000382
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Family Relationship
-
Montefiore Medical CenterChildren's Bureau - Administration for Children and FamiliesCompletedParenting | Family Relations | Relationship, FamilyUnited States
-
University of AarhusUniversity of Miami; TrygFonden, DenmarkCompletedFamily Relationship | Marital Conflict | Relationship DistressDenmark
-
Sun Yat-sen UniversityRecruitingRelationship, FamilyChina
-
The University of Hong KongThe Hong Kong Jockey Club Charities TrustCompleted
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA); American Academy of Child Adolescent...CompletedCoping Skills | Family RelationshipUnited States
-
United Nations Office on Drugs and Crime (UNODC)Polytechnique University of the Philippines; Anti-Drug Abuse Councils, LGUs...Enrolling by invitationFamily Relationship | Parenting SkillsPhilippines
-
University of KansasEnrolling by invitationParent-Child Relations | Parenting | Relationship, Marital | Fathers | Relationship, Family | Relationships, Father-ChildUnited States
-
The University of Hong KongCompletedSelf-esteem | Family Relationship | Self-efficacyChina
-
University of Texas Southwestern Medical CenterNot yet recruitingAdolescent | Depression | Emotional Dysregulation | Family Relationship | HRVUnited States
-
Beth Israel Deaconess Medical CenterNot yet recruitingRelationship, Family | Well-Being, PsychologicalUnited States
Clinical Trials on The Connected Family Series - For Foster Families
-
Jana HunsleyCompletedParenting | Family RelationsUnited States
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University... and other collaboratorsCompleted
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletedOppositional Defiant Disorder | Behaviour DisorderCanada
-
MDRCAbt Associates; Public Strategies; Child Trends; Optimal Solutions GroupCompletedChild Behavior | Adolescent Behavior | Family Relations | Low-Income Population | Marital RelationshipsUnited States
-
Oslo Metropolitan UniversityNorwegian Labour and Welfare AdministrationCompleted
-
Hong Kong Baptist UniversityUniversity Grants Committee, Hong KongCompletedAttention-deficit/Hyperactivity Disorder | Special Education | Attention Deficit Disorder | Special Needs Children | Hyperactivity DisorderHong Kong
-
Hong Kong Baptist UniversityUniversity Grants Committee, Hong KongCompletedDyslexia | Special Education | Special Needs ChildrenHong Kong
-
University of OklahomaTerminated
-
University of DelawareCompleted
-
Federal University of Rio Grande do SulHospital Moinhos de VentoCompleted