A Behavioral Intervention With Foster Families

• Sponsor: University of Arizona (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05405972
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 43

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Family Relationship; Sibling Relations; Behavior, Social	Behavioral: The Connected Family Series - For Foster Families	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Masking Description: Randomization to group was blinded and done by an independent statistician.
• Primary Purpose: Supportive Care
• Official Title: Effects of a Behavioral Intervention With Foster Families: A Randomized Controlled Trial
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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.	Behavioral: The Connected Family Series - For Foster Families; 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.

Outcome Measures

Primary Outcome Measures

1. Family Hardiness Index [Before intervention, up to 2 week]

   Psychometrically validated self-report tool for family functioning

Secondary Outcome Measures

1. Sibling Inventory of Behavior [Before intervention, up to 2 weeks]

   Psychometrically validated self-report tool for sibling relationships

Other Outcome Measures

1. Family Hardiness Index [After intervention, up to 3 months]

   Psychometrically validated self-report tool for family functioning

2. Sibling Inventory of Behavior [After intervention, up to 3 months]

   Psychometrically validated self-report tool for sibling relationships

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85721

Sponsors and Collaborators

• University of Arizona

Investigators

• Principal Investigator: Christine Platt, DNP/PhD, University of Arizona

Study Documents (Full-Text)

• Study Protocol - Jan 1, 2022
• Statistical Analysis Plan - Oct 25, 2021
• Informed Consent Form - Jan 4, 2022

More Information

Additional Information:

• 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)

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT05405972
• Other Study ID Numbers: STUDY00000382
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Arizona: Randomized controlled trial; Behavioral Intervention; Sibling; Foster Care

Study Results

No Results Posted as of Jun 6, 2022