NCT05405972

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

May 5, 2022

Last Update Submit

May 2, 2024

Conditions

Keywords

Randomized controlled trialBehavioral InterventionSiblingFoster Care

Outcome Measures

Primary Outcomes (1)

  • Family Hardiness Index

    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 Outcomes (1)

  • Sibling Inventory of Behavior

    Before intervention, up to 2 weeks

Other Outcomes (2)

  • Family Hardiness Index

    After intervention, up to 3 months

  • Sibling Inventory of Behavior

    After intervention, up to 3 months

Study Arms (2)

Group Receiving Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

A 4-week program involving videos and activities for both the parent and child in the home.

Group Receiving Intervention

Eligibility Criteria

Age7 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Links

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christine Platt, DNP/PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomization to group was blinded and done by an independent statistician.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

June 6, 2022

Study Start

May 15, 2022

Primary Completion

August 30, 2022

Study Completion

November 30, 2023

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations