Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04061031 |
| Other study ID # |
12662 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2019 |
| Est. completion date |
October 1, 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Milton S. Hershey Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The proposed study will examine two different intervention programs and whether they improve
self-regulation of adopted children. The study is a small randomized controlled trial to test
the feasibility of conducting a larger, R01-funded clinical trial. Outcomes will primarily be
focused on feasibility concerns, such as recruitment and retention of a sufficient number of
participants and implementation of treatment protocols with fidelity, as well as determining
initial effect size estimates that might inform later power analyses and examining the
functioning of developmental assessment measures when administered in the context of a
clinical trial.
Description:
In the year 2016, over 57,000 children were adopted from the child welfare system and another
118,000 were awaiting adoption, an increase of 7.9% and 8.1%, respectively, since 2013.
Children adopted from the child welfare system, on average, display significant and often
profound challenges with self-regulation, defined as the external and internal processes
responsible for determining one's emotional, behavioral, and cognitive reactions to stimuli.
Poor self-regulation is linked to a host of later untoward outcomes. Permanency for children
through the process of adoption offers an opportunity for improving developmental
trajectories and later outcomes for children. Psychosocial interventions that can
significantly improve the parent-child relationship hold promise for increasing the success
of the adoption and further promoting healthy development for children. Prior to proceeding
with an R01 application and funded clinical trial, a feasibility study is required for
multiple reasons. First, it is necessary to determine the likelihood of recruiting and
retaining a sufficient number of participants, the extent to which participants attend
sessions on a regular basis, caregiver satisfaction with treatment, and potential barriers to
clinicians implementing the intervention protocols with fidelity (Specific Aim 1), Second, a
number of developmental measures will be implemented to examine improvement. These measures
are typically administered in longitudinal developmental research, not clinical research, and
the sensitivity of these tools to change is unknown. Therefore, this project will allow for a
pilot examination of the implementation of these tools in a clinical context and the extent
to which change may occur (Specific Aim 2). Finally, effect size estimates of change for key
outcome metrics (i.e., self-regulation, parent-child relationship) will be derived to inform
power analyses and sample size determinations for an R01 application (Specific Aim 3). For
the current study, 30 adoptive parent-child dyads (child ages 4-9) will be recruited and
randomly assigned to receive one of two interventions. As an inclusion criteria, all children
will be required to receive a parent-reported clinically elevated or borderline score on the
Total Score of the Strengths and Difficulties Questionnaire (SDQ; ≥ 14) as an index of
self-regulation. The SDQ will be used as an outcome measure, as well as a number of other
objective report measures, observations, interviews, and child-completed tasks. Dyads will be
recruited through the Penn State Children's Hospital's TLC Research and Treatment Center and
established partnerships with local adoption agencies.
