Self-regulationNCT04061031
Improving Self-Regulation Among Adopted Children
A study testing Parent-Child Interaction Therapy (PCIT) and Child-Centered Therapy with Parent Education in people with Self-regulation, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Self-regulation
- What is being tested?
- Parent-Child Interaction Therapy (PCIT) and Child-Centered Therapy with Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 1 Oct 2022
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is living with an adoptive caregiver
- Caregiver reports a qualifying score for the child on the SDQ
- Fluent in English
- Child is rated by the caregiver with a score of 14 or greater on the full scale of the SDQ.
Who cannot join
- Child diagnosed with a severe developmental delay and/or psychiatric problem that necessitates a higher level of care.
- IQ below 70 as assessed at the time of the first assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Improving Self-Regulation Among Adopted Children: A Randomized Controlled Feasibility Trial
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.
Read the detailed 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.
- Conditions
- Self-regulation
- Being tested
- Parent-Child Interaction Therapy (PCIT), Child-Centered Therapy with Parent Education
- Keywords
- Self-regulation, adoption, parent-child realtionship
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction Therapy (PCIT)Behavioural
A trained clinician teaches the caregiver to deliver a number of behavior modification techniques for use with the child and coaches the caregiver in the delivery of those techniques.
Child-Centered Therapy with Parent EducationBehavioural
Also called Treatment-as-Usual
A trained clinician delivers non-directive, child-centered treatment techniques with the child while providing education to the parent based on current recommendations from the Department of Health and Human Services' Child Welfare Information Gateway.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Child Interaction Therapy | Experimental | Not described Receives: Behavioral: Parent-Child Interaction Therapy (PCIT) |
| Child-Centered Therapy with Parent Education | Active comparator | Not described Receives: Behavioral: Child-Centered Therapy with Parent Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire (SDQ)
A measure of broadband concerns with emotional, behavioral, cognitive, and social regulation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start14 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-regulationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Allen, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061031
- Sponsor's protocol ID
- 12662
- Status last verified
- Dec 2021
- First submitted
- 16 Aug 2019
- Last updated
- 16 Dec 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 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Regulation Among Adopted Children: A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT04061031
- Acronym / sponsor ID
- 12662
- Conditions
- Self-regulation
- Keywords
- Self-regulation, adoption, parent-child realtionship
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 19 Aug 2019 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-Child Interaction Therapy | Experimental | Behavioral: Parent-Child Interaction Therapy (PCIT) |
| Child-Centered Therapy with Parent Education | Active comparator | Behavioral: Child-Centered Therapy with Parent Education |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child is living with an adoptive caregiver
- Caregiver reports a qualifying score for the child on the SDQ
- Fluent in English
- Child is rated by the caregiver with a score of 14 or greater on the full scale of the SDQ.
Key exclusion criteria (2 listed)
- Child diagnosed with a severe developmental delay and/or psychiatric problem that necessitates a higher level of care.
- IQ below 70 as assessed at the time of the first assessment.
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 |
|---|---|---|
| Parent-Child Interaction Therapy (PCIT)A trained clinician teaches the caregiver to deliver a number of behavior modification techniques for use with the child and coaches the caregiver in the delivery of those techniques. | Behavioural | Parent-Child Interaction Therapy |
| Child-Centered Therapy with Parent EducationAlso: Treatment-as-UsualA trained clinician delivers non-directive, child-centered treatment techniques with the child while providing education to the parent based on current recommendations from the Department of Health and Human Services' Child Welfare Information Gateway. | Behavioural | Child-Centered Therapy with Parent Education |
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 6 months
A measure of broadband concerns with emotional, behavioral, cognitive, and social regulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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 Parent-Child Interaction Therapy (PCIT) and Child-Centered Therapy with Parent Education in people with Self-regulation, run by Milton S. Hershey Medical Center 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 2 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: withdrawn, as of the sponsor's last update on 16 Dec 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 was withdrawn before enrolling participants, so there are no results.
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?
Strengths and Difficulties Questionnaire (SDQ) (time frame: 6 months). 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 16 Dec 2021.