Parent-Child RelationsNCT04488523
Family Telehealth Project for Foster Care Youth
A study testing Family-based Telehealth Intervention in people with Parent-Child Relations and Communication, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this research is to adapt and evaluate the efficacy of an existing family based intervention to be delivered via telehealth to child welfare-involved (CWI) youth and their caregiver of origin. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Parent-Child Relations, Communication
- What is being tested?
- Family-based Telehealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Nov 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible youth:
- Will be between the ages of 12 and 18 years
- Will have ongoing child welfare involvement
- Will be proficient in English
- Will have no cognitive impairment which would preclude provision of informed assent
- Eligible caregivers for dyadic version:
Show all 13Show fewer
- Will be the caregiver of origin for the enrolled youth
- Will be proficient in English or Spanish
- Will be cognitively capable of providing informed consent for themselves and their youth
- Eligible caregivers for caregiver-only version:
- Will be the caregiver of a youth, between the ages of 12 and 18 years, with ongoing child welfare involvement
- Will be proficient in English or Spanish
- Will have no cognitive impairment which would preclude provision of informed consent
Who cannot join
- Caregivers whose rights were terminated due to substantiated abuse or neglect.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94131
About this study
Official title: Leveraging Technology to Improve Family Relationships for Adolescents in Out-of-Home Placement
The purpose of this research is to adapt and evaluate the efficacy of an existing family based intervention to be delivered via telehealth to child welfare-involved (CWI) youth and their caregiver of origin.
Read the detailed description
The goal of this study is to adapt and evaluate the efficacy of an existing empirically supported, family-based affect management intervention to be delivered via telehealth. There are two versions of this intervention: 1) a dyadic version to be delivered to CWI youth and their caregiver of origin, and 2) a caregiver-only version to be delivered to any caregiver (including kinship caregivers) of a CWI youth. The study involves iteratively adapting the intervention with feedback from youth and caregiver participants and stakeholder partners, as well as evaluating the feasibility, acceptability, and preliminary effectiveness of the intervention.
- Conditions
- Parent-Child Relations, Communication
- Being tested
- Family-based Telehealth Intervention
- Keywords
- telehealth, parent-child relationships, adolescent, Quality communication, Housing stability, Child welfare, Emotional regulation
- Medical subject headings
- Communication, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based Telehealth InterventionBehavioural
The Family Telehealth intervention focuses on improving parent-child relationships and communication.
For the dyadic version, the intervention involves eleven hours of intervention material; it includes motivational interviews, individual and joint sessions co-led by two separate clinicians. The sessions will be delivered on a weekly basis.
For the caregiver-only version, the intervention involves six hours of intervention material; it includes a motivational interview and individual sessions led by a single clinician. The sessions will be delivered on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Family-based Telehealth Treatment | Experimental | A family-based telehealth intervention. Receives: Behavioral: Family-based Telehealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale
To measure caregiver and youth affect management skills. Scores range from 36 to 180, with higher scores indicating greater problems with emotion regulation.
Measured: Immediately after the intervention.
Difficulties in Emotion Regulation Scale
To measure caregiver and youth affect management skills. Scores range from 36 to 180, with higher scores indicating greater problems with emotion regulation.
Measured: Three months post-intervention.
Parent-adolescent General Communication Scale (PPAC)
To measure caregiver-youth communication. The PPAC measures both positive and negative communication. Scores for positive communication ranging from 7 to 35, with higher scores indicating more positive communication. Scores for negative communication range from 13 to 65, with higher scores indicating more negative communication.
Measured: Immediately after the intervention.
Parent-adolescent General Communication Scale
To measure caregiver-youth communication. The PPAC measures both positive and negative communication. Scores for positive communication ranging from 7 to 35, with higher scores indicating more positive communication. Scores for negative communication range from 13 to 65, with higher scores indicating more negative communication.
Measured: Three months post-intervention.
Secondary outcomes (6)
Telehealth Satisfaction Questionnaire
To measure attitudes about the delivery of the intervention via telehealth.
Measured: Immediately after the intervention.
Family telehealth feedback form
To measure attitudes about the content and delivery of the intervention.
Measured: Two weeks post-baseline.
Family telehealth feedback form
To measure attitudes about the content and delivery of the intervention.
Measured: Three weeks post-baseline.
Family telehealth feedback form
To measure attitudes about the content and delivery of the intervention.
Measured: Four weeks post-baseline.
Family telehealth feedback form
To measure attitudes about the content and delivery of the intervention.
Measured: Five weeks post-baseline.
Family telehealth feedback form
To measure attitudes about the content and delivery of the intervention.
Measured: Nine weeks post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jul 2019
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
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 RelationsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed to iteratively adapt a family-based intervention with feedback from youth and caregiver participants and stakeholder partners, as well as to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Visa Foundation
- Responsible party
- Sponsor
- Investigators
- Marina Tolou-Shams, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488523
- Sponsor's protocol ID
- 1928922
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2020
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folk JB, Valencia-Ayala C, Holloway ED, Anvar S, Czopp A, Tolou-Shams M. Feasibility and Acceptability of a Family-Based Telehealth Intervention for Families Impacted by the Child Welfare System: Formative Mixed Methods Evaluation. JMIR Form Res. 2024 Oct 15;8:e57939. doi: 10.2196/57939.
PubMed 39405104
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Technology to Improve Family Relationships for Adolescents in Out-of-Home Placement
- ClinicalTrials.gov ID
- NCT04488523
- Acronym / sponsor ID
- 1928922
- Conditions
- Parent-Child Relations, Communication
- Keywords
- telehealth, parent-child relationships, adolescent, Quality communication, Housing stability, Child welfare, Emotional regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Visa Foundation
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 28 Jul 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 purpose of this research is to adapt and evaluate the efficacy of an existing family based intervention to be delivered via telehealth to child welfare-involved (CWI) youth and their caregiver of origin.
Detailed description
The goal of this study is to adapt and evaluate the efficacy of an existing empirically supported, family-based affect management intervention to be delivered via telehealth. There are two versions of this intervention: 1) a dyadic version to be delivered to CWI youth and their caregiver of origin, and 2) a caregiver-only version to be delivered to any caregiver (including kinship caregivers) of a CWI youth. The study involves iteratively adapting the intervention with feedback from youth and caregiver participants and stakeholder partners, as well as evaluating the feasibility, acceptability, and preliminary effectiveness of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed to iteratively adapt a family-based intervention with feedback from youth and caregiver participants and stakeholder partners, as well as to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Family-based Telehealth Treatment | Experimental | Behavioral: Family-based Telehealth InterventionA family-based telehealth intervention. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Will be between the ages of 12 and 18 years
- Will have ongoing child welfare involvement
- Will be proficient in English
- Will have no cognitive impairment which would preclude provision of informed assent
- Will be the caregiver of origin for the enrolled youth
Key exclusion criteria (1 listed)
- Caregivers whose rights were terminated due to substantiated abuse or neglect.
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 |
|---|---|---|
| Family-based Telehealth InterventionThe Family Telehealth intervention focuses on improving parent-child relationships and communication. For the dyadic version, the intervention involves eleven hours of intervention material; it includes motivational interviews, individual and joint sessions co-led by two separate clinicians. The sessions will be delivered on a weekly basis. For the caregiver-only version, the intervention involves six hours of intervention material; it includes a motivational interview and individual sessions led by a single clinician. The sessions will be delivered on a weekly basis. | Behavioural | Family-based Telehealth Treatment |
Primary outcome
Difficulties in Emotion Regulation Scale
Time frame: Immediately after the intervention.
To measure caregiver and youth affect management skills. Scores range from 36 to 180, with higher scores indicating greater problems with emotion regulation.
Difficulties in Emotion Regulation Scale
Time frame: Three months post-intervention.
To measure caregiver and youth affect management skills. Scores range from 36 to 180, with higher scores indicating greater problems with emotion regulation.
Parent-adolescent General Communication Scale (PPAC)
Time frame: Immediately after the intervention.
To measure caregiver-youth communication. The PPAC measures both positive and negative communication. Scores for positive communication ranging from 7 to 35, with higher scores indicating more positive communication. Scores for negative communication range from 13 to 65, with higher scores indicating more negative communication.
Parent-adolescent General Communication Scale
Time frame: Three months post-intervention.
To measure caregiver-youth communication. The PPAC measures both positive and negative communication. Scores for positive communication ranging from 7 to 35, with higher scores indicating more positive communication. Scores for negative communication range from 13 to 65, with higher scores indicating more negative communication.
6 secondary outcomes
Telehealth Satisfaction Questionnaire
Time frame: Immediately after the intervention.
Family telehealth feedback form
Time frame: Two weeks post-baseline.
Family telehealth feedback form
Time frame: Three weeks post-baseline.
Family telehealth feedback form
Time frame: Four weeks post-baseline.
Family telehealth feedback form
Time frame: Five weeks post-baseline.
Family telehealth feedback form
Time frame: Nine weeks post-baseline.
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 24 Jul 2026.
- Derived from this study: PubMed 39405104Folk JB, Valencia-Ayala C, Holloway ED, Anvar S, Czopp A, Tolou-Shams M. Feasibility and Acceptability of a Family-Based Telehealth Intervention for Families Impacted by the Child Welfare System: Formative Mixed Methods Evaluation. JMIR Form Res. 2024 Oct 15;8:e57939. doi: 10.2196/57939.
- 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.
Marina Tolou-Shams, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based Telehealth Intervention in people with Parent-Child Relations and Communication, run by University of California, San Francisco 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 13 inclusion and 1 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 24 Jul 2026. 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?
Difficulties in Emotion Regulation Scale (time frame: Immediately after the intervention.). The study lists 4 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 NCT04488523, 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 24 Jul 2026.