Family RelationsNCT04443504
An Online Post-Adoption Family Intervention Using Trust-Based Relational Intervention (TBRI) to Improve Understanding, Well-Being, and Connection in Adoptive Families
A study testing The Connected Family Series in people with Family Relations and Parenting, run by Jana Hunsley at 1 site in United States.
Trial summary
The current study aims to examine the effectiveness of an online, self-paced post-adoption intervention to improve understanding, well-being, and connection within adoptive families.To evaluate the effectiveness of this intervention, a mixed method, pre-post design with two conditions will be used. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Relations, Parenting
- What is being tested?
- The Connected Family Series
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 5 Apr 2021
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Study participants must be families who have legally adopted or have legal permanency of all children in their family.
- Study participants must have at least one adopted child in the family.
- Adoptive families who have at least two children with at least one child being 12 years or older. It does not matter if the child who is 12 years or older is an adopted or biological child in the family.
- All members of the family must be willing to participate in the intervention and all members 12 years and older must be willing to participate in the research assessments.
Who cannot join
- Families who are current foster homes.
- Families who have at least one member of the family who has recently been hospitalized for psychiatric issues.
- Families in which at least one member of the family is at risk of harm to self or others.
- Two-parent households in which the marriage is a consistent source of conflict.
- Families who have participated in Hope Connection 2.0, a therapeutic family camp.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on the Effectiveness of an Online Intervention for Adoptive Families
The current study aims to examine the effectiveness of an online, self-paced post-adoption intervention to improve understanding, well-being, and connection within adoptive families.To evaluate the effectiveness of this intervention, a mixed method, pre-post design with two conditions will be used. Data from standard, reliable measures and free-response items will be collected pre- and post-intervention from participants in two conditions: the intervention condition and the waitlist condition. The intervention condition involves receiving the intervention immediately following pre-assessments; the waitlist condition involves receiving the intervention approximately 3 months after the intervention condition once all data collection is completed.
The study aims to answer six research questions. Each research question involves analyses of the differences between the intervention and waitlist conditions across multiple time points.
- What is the intervention's effect on improving awareness of the needs of different family members and understanding how to meet these needs? Hypothesis 1: At post-intervention, parents in the intervention condition will report an improved awareness of the needs of each family member and greater understanding of how to meet these needs.
- What is the intervention's effect on parent well-being (i.e., parenting confidence and parenting stress) from pre- to post-intervention? Hypothesis 2: Parents in the intervention condition will report increased parenting confidence and trending decreases in parenting stress from pre- to post-intervention compared to those in the waitlist condition.
- What is the intervention's effect on child well-being (i.e., self-esteem and emotional and behavioral problems) from pre- to post-intervention? Hypothesis 3: Children in the intervention condition will report increased self-esteem and trending decreases in emotional and behavioral problems from pre- to post-intervention compared to those in the waitlist condition.
- What is the intervention's effect on the quality of the parent-child relationship from pre- to post-intervention? Hypothesis 4: Both parents and children in the intervention condition will report improved connection in the parent-child relationship from pre- to post-intervention compared to those in the waitlist condition.
- As an exploratory question, what is the intervention's effect on the quality of the sibling relationship from pre- to post-intervention? Hypothesis 5: Children in the intervention condition will report an improvement in the quality of their relationship with their sibling(s) from pre- to post-intervention compared to children in the waitlist condition.
- What is the intervention's effect on connection and communication within the overall family system from pre- to post-intervention? Hypothesis 6: Parents and children in the intervention condition will report increased family communication and family connection in the whole family system from pre- to post-intervention compared to parents and children in the waitlist condition.
Read the detailed description
One member of the family will complete a survey to ensure eligibility criteria have been met. In the recruitment application, the individual who completes the application will include an email address to be used as the primary contact person for the family. If the family meets the eligibility criteria, the primary contact person will receive consent forms to complete for each member of the family. Once consent forms are completed for the entire family and each member has agreed to participate in research, the primary contact will complete a demographic survey of basic household information. In the demographic survey, the primary contact will include email addresses for each family member 18 years and older. See timeline below for reference. *Note: dates are approximate.
Once consented, online surveys of pre-assessments will be sent to families via email (via individual links; survey links for children under 18 will be sent to the primary contact). Pre-assessments include individual, dyad, and family measures to examine the effectiveness of the intervention in multiple systems of the family. Each family member who is 12 years and older will complete pre-assessments during a one-week data collection period.
After pre-assessments are complete, families will be randomly assigned to the intervention or waitlist condition using a random number generator, and families will be notified of their assigned condition.
Both the waitlist and intervention condition will complete pre-assessments.
Once the pre-assessment data collection period is complete, families in the intervention condition will have one week before the intervention begins. The primary contact of families assigned to the intervention condition will receive an email with instructions to register and to prepare for the 4-week intervention series. The waitlist condition will do nothing during this time.
One week after pre-assessment data collection is complete, the 4-week intervention series will begin. The intervention includes 4 weekly sessions. Each weekly session involves parents watching a 15-minute mini-webinar, children watching a 5-minute video, parents and children 12 years and older completing separate reflection questions (*note these questions will be used as data for analysis), and families completing two family activities together (an activity aimed at improving connection and an activity aimed at improving communication). The primary contact will complete a checklist of which activities were completed that week. The intervention should take approximately 1.5-3 hours each week for the whole family for a total of 6-12 hours over the 4-week period.
The intervention condition will complete the first week's activities at their own pace within the seven days. On each subsequent Monday of the four weeks, the next week's activities will open for the intervention condition to access. The previous weeks' activities will still be available to the families during the duration of the intervention. All intervention activities will be completed within the four-week time period.
Two weeks after the intervention condition completes the intervention series, post-assessments will be sent to both the intervention and waitlist conditions. Post-assessments will be the same as the pre-assessments in order to examine differences between pre- and post-intervention. Families will have a one-week period to complete the post-assessments.
Three months after the intervention condition completed the intervention, 3-month follow-up assessments will be sent to both the intervention and waitlist conditions. 3-month follow-up assessments will be the same as the pre- and post-assessments. This follow-up data collection period is to determine any longer-term changes that may occur in the family systems post-intervention that may not occur closely following the intervention at the post-intervention data collection time point. Families will have a one-week period to complete the 3-month follow-up assessments.
One week after the three-month follow-up data collection period is completed, families randomly assigned to the waitlist condition will receive the invitation to register for the intervention. The waitlist condition will receive instructions to register for the intervention and to prepare for the 4-week intervention series. The waitlist condition will receive the intervention series in the same order and manner as the intervention condition.
Approximately 6 months after the intervention condition completed the intervention, the intervention condition will complete 6-month follow-up assessments. This follow-up data collection is to determine the long-term changes that may occur in the family system post-intervention. Only the intervention condition will complete this data collection period as the waitlist condition would have completed the intervention at this time.
In total, participation in this study will take approximately 15-20 hours during a 6-month period with approximately 4 hours total to complete surveys and assessments and 6-15 hours to participate in the intervention.
- Conditions
- Family Relations, Parenting
- Being tested
- The Connected Family Series
- Keywords
- post-adoption intervention, Trust-Based Relational Intervention, adoption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Connected Family SeriesBehavioural
The intervention is an online, self-paced post-adoption family intervention that occurs over a 4-week period to support adoptive families post-adoption.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: The Connected Family Series |
| Waitlist Group | No intervention | The waitlist group will receive the intervention 3 months after the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Family Cohesion
Family Adaptability and Cohesion Scale IV
Measured: through study completion, an average of 6 months
Change in Parent and Child Relationship
Inventory of Parent and Peer Attachment-Revised, Child-Parent Relationship Scale-Short Form
Measured: through study completion, an average of 6 months
Secondary outcomes (5)
Change in Parenting Stress
Parental Stress Scale
Measured: through study completion, an average of 6 months
Change in Parenting Competence
Parenting Sense of Competence Scale
Measured: through study completion, an average of 6 months
Change in Child Self-Esteem
Rosenberg Self-Esteem Scale
Measured: through study completion, an average of 6 months
Change in Child Emotional and Behavioral Problems
Strengths \& Difficulties Questionnaire
Measured: through study completion, an average of 6 months
Change in Sibling Relationship
Sibling Relationship Questionnaire
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jul 2020
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family RelationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be created using random assignment: an intervention group and a waitlist control group who will receive the intervention 3 months after the intervention group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jana Hunsley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jana Hunsley, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443504
- Sponsor's protocol ID
- 1920-217
- Status last verified
- Oct 2021
- First submitted
- 18 Jun 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effectiveness of an Online Intervention for Adoptive Families
- ClinicalTrials.gov ID
- NCT04443504
- Acronym / sponsor ID
- 1920-217
- Conditions
- Family Relations, Parenting
- Keywords
- post-adoption intervention, Trust-Based Relational Intervention, adoption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Jana HunsleyUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 23 Jun 2020 (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 current study aims to examine the effectiveness of an online, self-paced post-adoption intervention to improve understanding, well-being, and connection within adoptive families.To evaluate the effectiveness of this intervention, a mixed method, pre-post design with two conditions will be used. Data from standard, reliable measures and free-response items will be collected pre- and post-intervention from participants in two conditions: the intervention condition and the waitlist condition. The intervention condition involves receiving the intervention immediately following pre-assessments; the waitlist condition involves receiving the intervention approximately 3 months after the intervention condition once all data collection is completed.
The study aims to answer six research questions. Each research question involves analyses of the differences between the intervention and waitlist conditions across multiple time points.
- What is the intervention's effect on improving awareness of the needs of different family members and understanding how to meet these needs? Hypothesis 1: At post-intervention, parents in the intervention condition will report an improved awareness of the needs of each family member and greater understanding of how to meet these needs.
- What is the intervention's effect on parent well-being (i.e., parenting confidence and parenting stress) from pre- to post-intervention? Hypothesis 2: Parents in the intervention condition will report increased parenting confidence and trending decreases in parenting stress from pre- to post-intervention compared to those in the waitlist condition.
- What is the intervention's effect on child well-being (i.e., self-esteem and emotional and behavioral problems) from pre- to post-intervention? Hypothesis 3: Children in the intervention condition will report increased self-esteem and trending decreases in emotional and behavioral problems from pre- to post-intervention compared to those in the waitlist condition.
- What is the intervention's effect on the quality of the parent-child relationship from pre- to post-intervention? Hypothesis 4: Both parents and children in the intervention condition will report improved connection in the parent-child relationship from pre- to post-intervention compared to those in the waitlist condition.
- As an exploratory question, what is the intervention's effect on the quality of the sibling relationship from pre- to post-intervention? Hypothesis 5: Children in the intervention condition will report an improvement in the quality of their relationship with their sibling(s) from pre- to post-intervention compared to children in the waitlist condition.
- What is the intervention's effect on connection and communication within the overall family system from pre- to post-intervention? Hypothesis 6: Parents and children in the intervention condition will report increased family communication and family connection in the whole family system from pre- to post-intervention compared to parents and children in the waitlist condition.
Detailed description
One member of the family will complete a survey to ensure eligibility criteria have been met. In the recruitment application, the individual who completes the application will include an email address to be used as the primary contact person for the family. If the family meets the eligibility criteria, the primary contact person will receive consent forms to complete for each member of the family. Once consent forms are completed for the entire family and each member has agreed to participate in research, the primary contact will complete a demographic survey of basic household information. In the demographic survey, the primary contact will include email addresses for each family member 18 years and older. See timeline below for reference. *Note: dates are approximate.
Once consented, online surveys of pre-assessments will be sent to families via email (via individual links; survey links for children under 18 will be sent to the primary contact). Pre-assessments include individual, dyad, and family measures to examine the effectiveness of the intervention in multiple systems of the family. Each family member who is 12 years and older will complete pre-assessments during a one-week data collection period.
After pre-assessments are complete, families will be randomly assigned to the intervention or waitlist condition using a random number generator, and families will be notified of their assigned condition.
Both the waitlist and intervention condition will complete pre-assessments.
Once the pre-assessment data collection period is complete, families in the intervention condition will have one week before the intervention begins. The primary contact of families assigned to the intervention condition will receive an email with instructions to register and to prepare for the 4-week intervention series. The waitlist condition will do nothing during this time.
One week after pre-assessment data collection is complete, the 4-week intervention series will begin. The intervention includes 4 weekly sessions. Each weekly session involves parents watching a 15-minute mini-webinar, children watching a 5-minute video, parents and children 12 years and older completing separate reflection questions (*note these questions will be used as data for analysis), and families completing two family activities together (an activity aimed at improving connection and an activity aimed at improving communication). The primary contact will complete a checklist of which activities were completed that week. The intervention should take approximately 1.5-3 hours each week for the whole family for a total of 6-12 hours over the 4-week period.
The intervention condition will complete the first week's activities at their own pace within the seven days. On each subsequent Monday of the four weeks, the next week's activities will open for the intervention condition to access. The previous weeks' activities will still be available to the families during the duration of the intervention. All intervention activities will be completed within the four-week time period.
Two weeks after the intervention condition completes the intervention series, post-assessments will be sent to both the intervention and waitlist conditions. Post-assessments will be the same as the pre-assessments in order to examine differences between pre- and post-intervention. Families will have a one-week period to complete the post-assessments.
Three months after the intervention condition completed the intervention, 3-month follow-up assessments will be sent to both the intervention and waitlist conditions. 3-month follow-up assessments will be the same as the pre- and post-assessments. This follow-up data collection period is to determine any longer-term changes that may occur in the family systems post-intervention that may not occur closely following the intervention at the post-intervention data collection time point. Families will have a one-week period to complete the 3-month follow-up assessments.
One week after the three-month follow-up data collection period is completed, families randomly assigned to the waitlist condition will receive the invitation to register for the intervention. The waitlist condition will receive instructions to register for the intervention and to prepare for the 4-week intervention series. The waitlist condition will receive the intervention series in the same order and manner as the intervention condition.
Approximately 6 months after the intervention condition completed the intervention, the intervention condition will complete 6-month follow-up assessments. This follow-up data collection is to determine the long-term changes that may occur in the family system post-intervention. Only the intervention condition will complete this data collection period as the waitlist condition would have completed the intervention at this time.
In total, participation in this study will take approximately 15-20 hours during a 6-month period with approximately 4 hours total to complete surveys and assessments and 6-15 hours to participate in the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups will be created using random assignment: an intervention group and a waitlist control group who will receive the intervention 3 months after the intervention group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: The Connected Family Series |
| Waitlist Group | No intervention | –The waitlist group will receive the intervention 3 months after the intervention group. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Study participants must be families who have legally adopted or have legal permanency of all children in their family.
- Study participants must have at least one adopted child in the family.
- Adoptive families who have at least two children with at least one child being 12 years or older. It does not matter if the child who is 12 years or older is an adopted or biological child in the family.
- All members of the family must be willing to participate in the intervention and all members 12 years and older must be willing to participate in the research assessments.
Key exclusion criteria (5 listed)
- Families who are current foster homes.
- Families who have at least one member of the family who has recently been hospitalized for psychiatric issues.
- Families in which at least one member of the family is at risk of harm to self or others.
- Two-parent households in which the marriage is a consistent source of conflict.
- Families who have participated in Hope Connection 2.0, a therapeutic family camp.
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 SeriesThe intervention is an online, self-paced post-adoption family intervention that occurs over a 4-week period to support adoptive families post-adoption. | Behavioural | Intervention Group |
Primary outcome
Change in Family Cohesion
Time frame: through study completion, an average of 6 months
Family Adaptability and Cohesion Scale IV
Change in Parent and Child Relationship
Time frame: through study completion, an average of 6 months
Inventory of Parent and Peer Attachment-Revised, Child-Parent Relationship Scale-Short Form
5 secondary outcomes
Change in Parenting Stress
Time frame: through study completion, an average of 6 months
Change in Parenting Competence
Time frame: through study completion, an average of 6 months
Change in Child Self-Esteem
Time frame: through study completion, an average of 6 months
Change in Child Emotional and Behavioral Problems
Time frame: through study completion, an average of 6 months
Change in Sibling Relationship
Time frame: through study completion, an average of 6 months
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 12 Oct 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Family Relations and Parenting, run by Jana Hunsley 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 12 Oct 2021. 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?
Change in Family Cohesion (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. 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 12 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.