Postpartum DepressionNCT05400161
Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Impact on Child Development
A study testing MoodGym and Social Media-Based Parenting Program in people with Postpartum Depression and Parenting, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Parenting, Parent-Child Relations
- What is being tested?
- MoodGym and Social Media-Based Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 14 Apr 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who:
- Are >18 years old
- Screen positive for postpartum depression (score>9) on the EPDS at a -participating pediatric practice
- Have an infant <8 months of age
- Speak and Read English
- Have Access to a smart phone or computer tablet with internet access
- Children who:
- -Are < 8 months old
Who cannot join
- Women who:
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
- Report severe depressive symptoms (EPDS>20) at enrollment.
- Have a substantiated report of child maltreatment
- Children who:
- Were born premature (estimated gestational age<35 weeks)
- Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
- Are already currently receiving early intervention services for developmental delays at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
Official title: Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.
Read the detailed description
Postpartum depression (PPD) symptoms are common among women following the birth of a child and can adversely impact a mother's ability to care for her child. As a result, infants of mothers with PPD symptoms may experience less responsive parenting, placing them at greater risk for delays in development. Evidence- based parenting programs have been developed to guide mothers with caring for their infants but may not address the impact of depression on parenting, are intensive and expensive to administer with limited ability for scale up, or are not available in a format that facilitates participation by women with depressive symptoms. To address these barriers, investigators developed a theoretically-driven social media-based parenting program on responsive parenting and child development.
To determine whether the social media-based parenting program can improve responsive parenting and signal greater child development among women with PPD symptoms, investigators will conduct a prospective individually randomized group treatment trial. 113 eligible women who screen positive for PPD at their infants' well child visit and their children will be consented, enrolled, and randomized as mother-child dyads 1:1 to receive a) the social media-based parenting program plus online depression treatment or b) online depression treatment alone. Investigators chose a randomized design, because it is most effective in guarding against bias and will ensure that patients in both arms are similar in observed and unobserved characteristics. Treatment assignment will be done at the time of enrollment following informed consent.
Descriptive statistics for demographic and poverty characteristics and PPD symptoms measured at baseline will be examined across the two treatment groups to assess the success of the randomization. Investigators will assess responsive parenting at baseline and 3 months post-enrollment. Secondary endpoints which include the changes in EPDS, PSOC, and PSI-SF scores measured between baseline and the 3-month follow-up between groups, will be explored to determine if the effects of the parenting program are consistent with preliminary study findings. The secondary child developmental outcomes will include differences in the Bayley-3 cognitive, language, and motor subscale scores at the 12-month follow-up visit. The intervention arm will also be assessed with the Therapeutic Factors Inventory-8 (TFI-8) to measure cohesion and the Acceptability survey which measures feasibility of the parenting program at 3-months post-enrollment. Additionally, at the 3-month mark, all participants will be administered the MoodGym Acceptability Survey to assess feasibility of the online depression treatment program.
The results of this application would be expected to contribute important new knowledge and inform a future trial on parenting strategies to better assist mothers with PPD symptoms and improve child developmental outcomes.
- Being tested
- MoodGym, Social Media-Based Parenting Program
- Keywords
- Social Media, Parenting, Postpartum Depression, Mothers, Infants, Childhood Developmental Outcomes, Postpartum, Depression, Mother-Infant Interactions
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodGymBehavioural
Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. Investigators will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
Social Media-Based Parenting ProgramBehavioural
Participants in the intervention group will be enrolled in Facebook secret user groups, administered by a trained facilitator, to permit participants to view and comment on posted materials. Content and user identity are restricted to invited participants to maintain privacy. Investigators will organize educational materials into video vignettes, narrated PowerPoint presentations, and written materials. The facilitator reviews and comments on postings daily and provides feedback to participants. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed and counts of sessions viewed and comments posted. Participants randomized to the intervention will also have the option to take part in a preliminary virtual session through a secure video platform (e.g. BlueJeans) and will receive weekly engagement text messages. Women in the intervention group will be enrolled in the online depression treatment program, MoodGym.
| Study group | Role | What they receive |
|---|---|---|
| MoodGym Alone | Active comparator | The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction. Receives: Behavioral: MoodGym |
| Parenting Program + MoodGym | Experimental | The social media-based parenting program consists of 8 weekly sessions using a Facebook platform with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym. Receives: Behavioral: MoodGym; Behavioral: Social Media-Based Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in parent-child interactions
The Parent Child Early Relational Assessment (PCERA) will be used to assess parent-child interactions. The PCERA is a validated 65-item videotape assessment designed to measure the quality of affect and behavior in parent-infant interactions. The PCERA uses ratings that are based on observations of 5-minute videotaped interactions with parent-infant dyads engaged in free play. The PCERA contains 8 subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental Intrusiveness, Insensitivity, and Inconsistency. Each individual subscale is scored between 0-5, with higher scores indicating more responsive parenting. A subscale score of 1-2 indicates an area of concern, a score of 3 indicates some concern, and a score of 4-5 in
Measured: Baseline and 3-months
Secondary outcomes (9)
Changes in severity of depressive symptoms
Severity of depressive symptoms will be measured by using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a validated 10-item self-report measure of depressive symptoms with strong evidence for reliability, validity, and utility in varying populations. It has been used extensively in mental health research and provides cutpoints to determine the severity of depressive symptoms. It includes a question on suicidal thoughts and wishes (#10) that will be used to monitor for suicidality. The total score (range: 0-30) will be used with scores of 10 or higher representing minor or moderate depression and scores of 20 or greater representing severe depression.These outcomes will assess changes in EPDS from baseline to 3 months.
Measured: Monthly (Baseline to 12-months)
Changes in parenting competence
Parenting competence will be measured using the Parenting Sense of Competence Scale (PSOC). The PSOC is a validated 17-item self-report measure of parenting self-esteem and competence and consists of two factors: satisfaction and efficacy. Response categories are on a 6-point likert-scale from strongly disagree to strongly agree. The total score (range: 17-102), which includes the sum of the two factors, will be used. A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool. These outcomes will assess changes in PSOC from baseline to 3 months.
Measured: Baseline and 3-months
Changes in parenting stress
Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a validated 36-item scale that measures parenting stress. The PSI-SF is a direct derivative of the full-length test (PSI) and it has been shown to have excellent internal consistency and to be positively associated with maternal psychological distress. Scores on the PSI-SF correlate well with the full-length PSI. It yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The total score (range: 36-180) will be used, with higher scores indicating higher levels of stress.These outcomes will assess changes in PSI-SF from baseline to 3 months.
Measured: Baseline and 3-months
Prior mental health service use
Prior mental health service use will be measured using the National Comorbidity Survey (NCS), which provides data on mental health treatment in the United States. Investigators will include a question from the NCS on prior mental health services use in the past month: "In the past month, did you receive treatment for problems with your emotions or nerves, or your use of alcohol or drugs?" We will consider mental health service use to have occurred in the past month if a mother responds "Yes" to this question. The results indicate the number of participants from each group who received mental health services/treatment at each time point. Additionally, if a mother responds "Yes" to the initial NCS item, a follow-up question will be asked to determine the specific types of services that were accessed: "If yes, what type of treatment did you receive?"
Measured: Monthly (Baseline to 12-months)
Social support
Social support will be measured using the Multi-dimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item scale that assesses perceived social support from family, friends, and a significant other. Response categories are on a 7-point likert-scale from 1=very strongly disagree to 7=very strongly agree. The total score will be used (range: 12-84).
Measured: Baseline
Therapy group cohesion
Therapy group cohesion will be measured using the TFI-8. The TFI-8 is a validated 8-item scale that is used to measure cohesion and is continuous process monitoring for therapy groups. Scores on the TFI-8 correlate well with the full TFI. The total score (range: 8-56) will be used, with higher scores indicating greater cohesion within the group. The TFI-8 will be administered at the 3-month visit to the intervention group, only.
Measured: 3-months
Acceptability of the parenting program
Acceptability of the parenting program will be measured using the Acceptability Survey. The Acceptability Survey is a 10-item scale with 3 additional open ended questions. The total score (range: 9-45) will be used and the open ended questions will be qualitatively analyzed to help inform the acceptability scores. Higher scores on the acceptability survey indicate greater satisfaction and feasibility of the parenting program. The acceptability survey will be administered at the 3-month visit to the intervention, only.
Measured: 3-months
Acceptability of the online depression treatment program
The acceptability of the online depression treatment program, MoodGym, will be measured using the MoodGym Acceptability Survey. The survey includes two qualitative open-ended questions and an additional question that asks, "It is ___________ that I will use MoodGym compared to going to a health care provider for depression treatment." The response is a 5-point likert-scale from "Much More Likely" to "Much Less Likely". The open ended questions will be qualitatively analyzed to help inform the acceptability scores. The MoodGym Acceptability survey will be administered at the 3-month visit to all participants.
Measured: 3-months
Child Development
Child development will be measured using the Bayley Scales of Infant and Toddler Development-3rd Edition (BSID-III). The BSID-III is a validated scale of child development from 1 to 42 months of age. The BSID-III has excellent reliability and correlates well with other measures of development including the Wechsler Preschool and Primary Scale of Intelligence (r=0.83). The BSID-III has three subscales that will be utilized (cognitive, motor, and language).
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start18 Nov 2022
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- James Guevara, MD,MPH, Principal investigator, Children's Hospital of PhiladelphiaRhonda Boyd, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400161
- Sponsor's protocol ID
- 22-019784
- Other IDs
- R33MH118405
- Status last verified
- Jul 2025
- First submitted
- 27 May 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms
- ClinicalTrials.gov ID
- NCT05400161
- Acronym / sponsor ID
- 22-019784
- Keywords
- Social Media, Parenting, Postpartum Depression, Mothers, Infants, Childhood Developmental Outcomes, Postpartum, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 1 Jun 2022 (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 long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.
Detailed description
Postpartum depression (PPD) symptoms are common among women following the birth of a child and can adversely impact a mother's ability to care for her child. As a result, infants of mothers with PPD symptoms may experience less responsive parenting, placing them at greater risk for delays in development. Evidence- based parenting programs have been developed to guide mothers with caring for their infants but may not address the impact of depression on parenting, are intensive and expensive to administer with limited ability for scale up, or are not available in a format that facilitates participation by women with depressive symptoms. To address these barriers, investigators developed a theoretically-driven social media-based parenting program on responsive parenting and child development.
To determine whether the social media-based parenting program can improve responsive parenting and signal greater child development among women with PPD symptoms, investigators will conduct a prospective individually randomized group treatment trial. 113 eligible women who screen positive for PPD at their infants' well child visit and their children will be consented, enrolled, and randomized as mother-child dyads 1:1 to receive a) the social media-based parenting program plus online depression treatment or b) online depression treatment alone. Investigators chose a randomized design, because it is most effective in guarding against bias and will ensure that patients in both arms are similar in observed and unobserved characteristics. Treatment assignment will be done at the time of enrollment following informed consent.
Descriptive statistics for demographic and poverty characteristics and PPD symptoms measured at baseline will be examined across the two treatment groups to assess the success of the randomization. Investigators will assess responsive parenting at baseline and 3 months post-enrollment. Secondary endpoints which include the changes in EPDS, PSOC, and PSI-SF scores measured between baseline and the 3-month follow-up between groups, will be explored to determine if the effects of the parenting program are consistent with preliminary study findings. The secondary child developmental outcomes will include differences in the Bayley-3 cognitive, language, and motor subscale scores at the 12-month follow-up visit. The intervention arm will also be assessed with the Therapeutic Factors Inventory-8 (TFI-8) to measure cohesion and the Acceptability survey which measures feasibility of the parenting program at 3-months post-enrollment. Additionally, at the 3-month mark, all participants will be administered the MoodGym Acceptability Survey to assess feasibility of the online depression treatment program.
The results of this application would be expected to contribute important new knowledge and inform a future trial on parenting strategies to better assist mothers with PPD symptoms and improve child developmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoodGym Alone | Active comparator | Behavioral: MoodGymThe MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction. |
| Parenting Program + MoodGym | Experimental | Behavioral: MoodGym, Behavioral: Social Media-Based Parenting ProgramThe social media-based parenting program consists of 8 weekly sessions using a Facebook platform with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are >18 years old
- Screen positive for postpartum depression (score>9) on the EPDS at a -participating pediatric practice
- Have an infant <8 months of age
- Speak and Read English
- Have Access to a smart phone or computer tablet with internet access
Key exclusion criteria (8 listed)
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
- Report severe depressive symptoms (EPDS>20) at enrollment.
- Have a substantiated report of child maltreatment
- Were born premature (estimated gestational age<35 weeks)
- Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
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 |
|---|---|---|
| MoodGymParticipants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. Investigators will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage). | Behavioural | MoodGym Alone, Parenting Program + MoodGym |
| Social Media-Based Parenting ProgramParticipants in the intervention group will be enrolled in Facebook secret user groups, administered by a trained facilitator, to permit participants to view and comment on posted materials. Content and user identity are restricted to invited participants to maintain privacy. Investigators will organize educational materials into video vignettes, narrated PowerPoint presentations, and written materials. The facilitator reviews and comments on postings daily and provides feedback to participants. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed and counts of sessions viewed and comments posted. Participants randomized to the intervention will also have the option to take part in a preliminary virtual session through a secure video platform (e.g. BlueJeans) and will receive weekly engagement text messages. Women in the intervention group will be enrolled in the online depression treatment program, MoodGym. | Behavioural | Parenting Program + MoodGym |
Primary outcome
Changes in parent-child interactions
Time frame: Baseline and 3-months
The Parent Child Early Relational Assessment (PCERA) will be used to assess parent-child interactions. The PCERA is a validated 65-item videotape assessment designed to measure the quality of affect and behavior in parent-infant interactions. The PCERA uses ratings that are based on observations of 5-minute videotaped interactions with parent-infant dyads engaged in free play. The PCERA contains 8 subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental Intrusiveness, Insensitivity, and Inconsistency. Each individual subscale is scored between 0-5, with higher scores indicating more responsive parenting. A subscale score of 1-2 indicates an area of concern, a score of 3 indicates some concern, and a score of 4-5 in
9 secondary outcomes
Changes in severity of depressive symptoms
Time frame: Monthly (Baseline to 12-months)
Changes in parenting competence
Time frame: Baseline and 3-months
Changes in parenting stress
Time frame: Baseline and 3-months
Prior mental health service use
Time frame: Monthly (Baseline to 12-months)
Social support
Time frame: Baseline
Therapy group cohesion
Time frame: 3-months
Acceptability of the parenting program
Time frame: 3-months
Acceptability of the online depression treatment program
Time frame: 3-months
Child Development
Time frame: 12-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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.
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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.
James Guevara, MD,MPH principal investigator
Children's Hospital of Philadelphia
Rhonda Boyd, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoodGym and Social Media-Based Parenting Program in people with Postpartum Depression and Parenting, run by Children's Hospital of Philadelphia 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 8 inclusion and 8 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 22 Jul 2025. 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?
Changes in parent-child interactions (time frame: Baseline and 3-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 22 Jul 2025.