Parent-Child RelationshipNCT04580459
CARE Mentalizing-Focused Parenting Group Outcomes Study
A study testing CARE Parenting Group Treatment and Treatment as Usual (TAU) in people with Parent-Child Relationship and Parenting, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to evaluate the 12-week mentalizing-focused group parenting intervention, Connecting and Reflecting Experience (CARE), relative to a treatment as usual (TAU) group in an outpatient child mental health clinic. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Parent-Child Relationship, Parenting
- What is being tested?
- CARE Parenting Group Treatment and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Aug 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents/caregivers of child receiving mental health services at community child outpatient clinic
- English- or Spanish-speaking
Who cannot join
- Parent has severe mental illness or significant cognitive impairment
- Child has significant developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10470
About this study
Official title: Connecting and Reflecting Experience (CARE) Mentalizing-Focused Parenting Group Treatment Outcomes Study
The primary objective of this clinical trial is to evaluate the 12-week mentalizing-focused group parenting intervention, Connecting and Reflecting Experience (CARE), relative to a treatment as usual (TAU) group in an outpatient child mental health clinic.
- Conditions
- Parent-Child Relationship, Parenting
- Being tested
- CARE Parenting Group Treatment, Treatment as Usual (TAU)
- Keywords
- Attachment, Parenting, Parent-Child Relationship, Caregivers, Parents, Child Mental Health, Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE Parenting Group TreatmentBehavioural
The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.
Treatment as Usual (TAU)Behavioural
Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.
| Study group | Role | What they receive |
|---|---|---|
| CARE Parenting Group Treatment | Experimental | Participants receive the CARE mentalizing-focused group parenting intervention. Receives: Behavioral: CARE Parenting Group Treatment |
| Treatment as Usual (TAU) | Other | Participants continue to receive treatment as usual in the outpatient child mental health clinic. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental reflective functioning
Change in parental reflective functioning as measured by parent/caregiver report on the Parental Reflective Functioning Questionnaire. Responses are reported on a 7-point Likert scale from 1 to 7. Total scores for the three sub-scales (Pre-Mentalizing Modes, Certainty about Mental States, and Interest and Curiosity) range from 6 to 42. Lower scores on Pre-Mentalizing Modes, moderate scores on Certainty about Mental States, and higher scores on Interest and Curiosity indicate better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in parenting stress
Change in parenting stress as measured by parent/caregiver report on the Parenting Stress Index. Responses are reported on a 5-point Likert scale from 1 to 5. Total scores for the Parenting Stress Index (PSI-SF-4) range from 36 to 180, with lower scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Secondary outcomes (9)
Change in parent psychiatric distress
Change in parent/caregiver psychiatric distress as measured by parent/caregiver report on the Brief Symptom Inventory. Responses are reported on a 5-point Likert scale from 0 to 4. Global severity index scores for the Brief Symptom Inventory (BSI-18) range from 0 to 82, with lower scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in child social-emotional impairment
Change in children's social-emotional impairment as measured by parent/caregiver and child report on the Youth Outcome Questionnaire. Responses are reported on a 5-point Likert scale from 0 to 4. Total scores on the Youth Outcomes Questionnaire (Y-OQ-30.2) range from 0 to 120, with lower scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in family functioning
Change in family functioning as measured by parent/caregiver and child report on the Family Assessment Device. Responses are reported on a 4-point Likert scale from 1 to 4. Total scores on the General Functioning scale of the Family Assessment Device range from 12 to 48, with lower scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in parent emotion regulation
Change in parent/caregiver emotion regulation as measured by parent/caregiver report on the Difficulties with Emotion Regulation Scale. Responses are reported on a 5-point Likert scale from 1 to 5. Total scores for the Difficulties with Emotion Regulation Scale (DERS-18) range from 18 to 90, with lower scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in parent perceptions of social support
Change in parent/caregiver perceptions of social support as measured by parent/caregiver report on the Interpersonal Support Evaluation List. Responses are reported on a 4-point Likert scale from 0 to 3. Total scores on the Interpersonal Support Evaluation List (ISEL-12) range from 0 to 36, with higher scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in parent perceptions of belongingness
Change in parent/caregiver perceptions of belongingness as measured by parent/caregiver report on the Sense of Belongingness Inventory. Responses are reported on a 4-point Likert scale from 1 to 4. Total scores for the Psychological Experience scale of the Sense of Belongingness Inventory range from 18 to 72, with higher scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in parent-child relationship
Change in parent-child relationship as measured by child report on the Security Scale. Responses are reported on a 4-point Likert scale from 1 to 4. Total scores on the Security Scale range from 1 to 96, with higher scores indicating better outcomes.
Measured: Baseline to post-intervention (12 weeks)
Change in reported exposure to adverse childhood experiences (ACEs)
Change in reported parent and child exposure to ACEs as measured by parent/caregiver report on the Adverse Childhood Experiences (ACE) questionnaire. Responses are reported on a binary (yes/no) scale. Total scores on the Adverse Childhood Experiences questionnaire range from 0 to 10.
Measured: Baseline and post-intervention (12 weeks)
Change in parent experiences of racism and discrimination
Change in reported distress in relation to experiences of racism and/or discrimination as measured by parent/caregiver report on the Daily Life Experiences scale of the Racism and Life Experience Scales. Responses are reported on two 6-point Likert scales from 0 to 5. Total scores on the Daily Life Experiences scale of the Racism and Life Experience Scales range from 0 to 100, with lower scores indicating better outcomes.
Measured: Baseline and post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parent-Child 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The FAR Fund
- Responsible party
- Sponsor
- Investigators
- Amanda Zayde, PsyD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580459
- Sponsor's protocol ID
- 2020-11240
- Status last verified
- May 2023
- First submitted
- 2 Oct 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zayde A, Derella OJ, Kilbride A. Safe haven in adolescence: Improving parental reflective functioning and youth attachment and mental health with the Connecting and Reflecting Experience. Infant Ment Health J. 2023 Mar;44(2):268-283. doi: 10.1002/imhj.22042. Epub 2023 Mar 2.
PubMed 36862314
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting and Reflecting Experience (CARE) Mentalizing-Focused Parenting Group Treatment Outcomes Study
- ClinicalTrials.gov ID
- NCT04580459
- Acronym / sponsor ID
- 2020-11240
- Conditions
- Parent-Child Relationship, Parenting
- Keywords
- Attachment, Parenting, Parent-Child Relationship, Caregivers, Parents, Child Mental Health, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- The FAR Fund
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 Oct 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 primary objective of this clinical trial is to evaluate the 12-week mentalizing-focused group parenting intervention, Connecting and Reflecting Experience (CARE), relative to a treatment as usual (TAU) group in an outpatient child mental health clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARE Parenting Group Treatment | Experimental | Behavioral: CARE Parenting Group TreatmentParticipants receive the CARE mentalizing-focused group parenting intervention. |
| Treatment as Usual (TAU) | Other | Behavioral: Treatment as Usual (TAU)Participants continue to receive treatment as usual in the outpatient child mental health clinic. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents/caregivers of child receiving mental health services at community child outpatient clinic
- English- or Spanish-speaking
Key exclusion criteria (2 listed)
- Parent has severe mental illness or significant cognitive impairment
- Child has significant developmental delay
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 |
|---|---|---|
| CARE Parenting Group TreatmentThe CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions. | Behavioural | CARE Parenting Group Treatment |
| Treatment as Usual (TAU)Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Change in parental reflective functioning
Time frame: Baseline to post-intervention (12 weeks)
Change in parental reflective functioning as measured by parent/caregiver report on the Parental Reflective Functioning Questionnaire. Responses are reported on a 7-point Likert scale from 1 to 7. Total scores for the three sub-scales (Pre-Mentalizing Modes, Certainty about Mental States, and Interest and Curiosity) range from 6 to 42. Lower scores on Pre-Mentalizing Modes, moderate scores on Certainty about Mental States, and higher scores on Interest and Curiosity indicate better outcomes.
Change in parenting stress
Time frame: Baseline to post-intervention (12 weeks)
Change in parenting stress as measured by parent/caregiver report on the Parenting Stress Index. Responses are reported on a 5-point Likert scale from 1 to 5. Total scores for the Parenting Stress Index (PSI-SF-4) range from 36 to 180, with lower scores indicating better outcomes.
9 secondary outcomes
Change in parent psychiatric distress
Time frame: Baseline to post-intervention (12 weeks)
Change in child social-emotional impairment
Time frame: Baseline to post-intervention (12 weeks)
Change in family functioning
Time frame: Baseline to post-intervention (12 weeks)
Change in parent emotion regulation
Time frame: Baseline to post-intervention (12 weeks)
Change in parent perceptions of social support
Time frame: Baseline to post-intervention (12 weeks)
Change in parent perceptions of belongingness
Time frame: Baseline to post-intervention (12 weeks)
Change in parent-child relationship
Time frame: Baseline to post-intervention (12 weeks)
Change in reported exposure to adverse childhood experiences (ACEs)
Time frame: Baseline and post-intervention (12 weeks)
Change in parent experiences of racism and discrimination
Time frame: Baseline and post-intervention (12 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 2 Jun 2023.
- Derived from this study: PubMed 36862314Zayde A, Derella OJ, Kilbride A. Safe haven in adolescence: Improving parental reflective functioning and youth attachment and mental health with the Connecting and Reflecting Experience. Infant Ment Health J. 2023 Mar;44(2):268-283. doi: 10.1002/imhj.22042. Epub 2023 Mar 2.
- Individual participant dataSharing planned: No
Related trials for Parent-Child Relationship
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Not yet recruitingObservational study
CIC101-02-LT is a Long-term Follow-up Study of Subjects Treated With TRTP-101 and Will Evaluate the Long-term Safety and Efficacy of TRTP-101.
Atrophic Scar
Not yet recruitingPhase 2
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
Malaria, Malaria Vivax
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
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.
Amanda Zayde, PsyD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE Parenting Group Treatment and Treatment as Usual (TAU) in people with Parent-Child Relationship and Parenting, run by Montefiore 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 2 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: finished, as of the sponsor's last update on 2 Jun 2023. 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 parental reflective functioning (time frame: Baseline to post-intervention (12 weeks)). 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?
On the ClinicalTrials.gov record for NCT04580459, which also lists 1 linked publication.
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 2 Jun 2023.