Family RelationshipNCT05405972
A Behavioral Intervention With Foster Families
A study testing The Connected Family Series - For Foster Families in people with Family Relationship and Sibling Relations, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to investigate a behavioral intervention with foster families. Read more about this study
- Who is it for?
- Ages 7 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Relationship, Sibling Relations, Behavior, Social
- What is being tested?
- The Connected Family Series - For Foster Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Behavioral Intervention With Foster Families: A Randomized Controlled Trial
The purpose of this study is to investigate a behavioral intervention with foster families.
Read the 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.
- Conditions
- Family Relationship, Sibling Relations, Behavior, Social
- Being tested
- The Connected Family Series - For Foster Families
- Keywords
- Randomized controlled trial, Behavioral Intervention, Sibling, Foster Care
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Connected Family Series - For Foster FamiliesBehavioural
A 4-week program involving videos and activities for both the parent and child in the home.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before intervention, up to 2 week
Secondary outcomes (1)
Sibling Inventory of Behavior
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
Measured: Before intervention, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start15 May 2022
- Primary completion30 Aug 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family RelationshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Platt, DNP/PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405972
- Sponsor's protocol ID
- STUDY00000382
- Status last verified
- May 2024
- First submitted
- 5 May 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Behavioral Intervention With Foster Families: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05405972
- Acronym / sponsor ID
- STUDY00000382
- Conditions
- Family Relationship, Sibling Relations, Behavior, Social
- Keywords
- Randomized controlled trial, Behavioral Intervention, Sibling, Foster Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Receiving Intervention | Experimental | Behavioral: The Connected Family Series - For Foster FamiliesThe 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. |
| 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. |
Who may qualify
- Ages
- 7 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Connected Family Series - For Foster FamiliesA 4-week program involving videos and activities for both the parent and child in the home. | Behavioural | Group Receiving Intervention |
Primary outcome
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
1 secondary outcome
Sibling Inventory of Behavior
Time frame: Before intervention, up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- 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, 74-83Link provided by the sponsor.
- 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, 104703Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Platt, DNP/PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Connected Family Series - For Foster Families in people with Family Relationship and Sibling Relations, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Hardiness Index (time frame: Before intervention, up to 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.