Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04443504 |
| Other study ID # |
1920-217 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
April 5, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Texas Christian University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
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.
