Intellectual DisabilityNCT05986305
Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities
A study testing Go Act and Peer in people with Intellectual Disability, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
This study will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities. Read more about this study
- Who is it for?
- Ages 11 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Go Act and Peer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2023to 30 Jun 2026
- 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 11 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parents
- Raising an adolescent or young adult child (age 11-27), with diagnosed or suspected intellectual or developmental disability
- Able to attend group sessions
- Able to give informed consent
- Resident of any state except New York or Illinois due to electronic signature law
- Youth
- Being between the ages of 11 and 27
- Having diagnosed or suspected intellectual or developmental disability
Who cannot join
- Parents
- Having evidence of emergency mental health needs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, 27510
UNC Adult Psychiatry Clinic
Chapel Hill, North Carolina, 27514
About this study
This study will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities. Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.
Read the detailed description
A well-functioning system of care should provide a broad array of services that can support families with a child with complex health care needs. Nonetheless, adolescents and transition age youth with intellectual and developmental disabilities experience rates of unmet need for health care up to 6 times higher than others resulting in poor health and quality of life for themselves and their families.
The system of care approach has achieved positive impacts for children with intellectual and developmental disabilities and their families, but updates call for training to help parents develop advocacy skills on behalf of their children. Prior research on diverse populations indicates that parent advocacy skills are a promising target for increasing parent self-efficacy, which in turn is associated with better parent and youth health outcomes. Parent advocacy skills can be increased through a psycho-educational advocacy skills curriculum or through parent-directed peer-learning. However, the comparative effectiveness of these two strategies for families raising youth with intellectual and developmental disabilities is not yet known.
This study has two objectives. First, it will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities . Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.
- Conditions
- Intellectual Disability
- Being tested
- Go Act, Peer
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go ActBehavioural
Go Act sessions address becoming a parent who can 'Go Act,' caring for one's self as a parent, understanding and managing youth health needs, working with health providers as partners, and working with other service providers such as schools and vocational services. The intervention uses motivational interviewing, story-telling with self-disclosure, psycho-education introduced with a know-want to know-learned strategy, problem-solving, role play, and practice outside of class.
PeerBehavioural
During Peer sessions facilitators lay ground rules for respectful and confidential sharing and encourage group discussion. The group provides a format to make personal connections through shared identity. Participants may discuss strategies for individualized advocacy, so that they learn from the experiences of others.
| Study group | Role | What they receive |
|---|---|---|
| Go Act | Active comparator | Go Act is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period. Receives: Behavioral: Go Act |
| Peer | Active comparator | Peer is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period. Receives: Behavioral: Peer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent activation
The Parent Patient Activation Measure will be used to capture parent activation on behalf of their child (mean score=70) at 6, 12 and 18 months after intervention. The Parent Patient Activation Measure is a parent self-report 13-item scale with 4-level likert responses and scores ranging from 0 to 100.
Measured: up to18 months after intervention
Change in youth social functioning- life satisfaction
Youth social functioning will be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children life satisfaction measure at 6, 12 and 18 months after intervention.
Measured: up to18 months after intervention
Change in parent depression
Parent depression will be measured with the 8-item Patient Health Questionnaire at 6, 12 and 18 months after intervention. The Patient Health Questionnaire is scored from 0 to 24.
Measured: up to 18 months after intervention
Secondary outcomes (10)
Change in parenting self-efficacy
The Tool to Measure Parenting Self-Efficacy will be used to assess parent self-efficacy at 6, 12 and 18 months after intervention. The Tool to Measure Parenting Self-Efficacy short version consists of 36-items rated on an 11-point likert scale, from 0 to 10 completely disagree to completely agree. Individual items are summed to create a total score, with higher scores indicating greater feelings of parenting self-efficacy.
Measured: up to 18 months after intervention
Change in shared decision-making
Shared decision-making will be assessed using a three-item scale from the National Survey of Children's Health at 6, 12 and 18 months after intervention. Respondents report on a 4-point likert scale (never, sometimes, usually, or always) whether they feel that they 1) discuss with providers a range of treatment options; 2) are encouraged to raise concerns; 3) make treatment choices together. Mean scores range from 1 to 4 never to always.
Measured: up to 18 months after intervention
Change in alliance
The adapted Parenting Alliance Inventory will be used to measure parent-teacher alliance at 6, 12 and 18 months after intervention. The Parenting Alliance Inventory was adapted to focus on parent-teacher alliance, and consists of 20 items scored on a 5-point likert scale, producing a mean score between 1 and 5 never to always.
Measured: up to 18 months after intervention
Change in goal attainment
Goal attainment will be assessed with the psychometric equivalence tested goal attainment scale at 6, 12 and 18 months after intervention. The goal attainment scale measurement system is based on a 5-point response scale ranging from -2 (worse expected outcome) to 2 (best expected outcome).
Measured: up to 18 months after intervention
Change in stress
Parent stress will be measured with the 17-item Parental Stress Scale at 6, 12 and 18 months after intervention. Mean scores range from 1 to 5 with higher scores indicating higher stress.
Measured: up to 18 months after intervention
Change in observed parent activation
Observed parent activation will be assessed through audio-recorded parent-physician conversations at 6, 12 and 18 months after intervention. Evidence of parent activation will be examined: 1) providing context, 2) giving feedback, and 3) asking questions. Audio-recordings will be transcribed and a coding manual created.
Measured: up to18 months after intervention
Change in youth social functioning- meaning & purpose
Youth social functioning will additionally be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children meaning and purpose measure at 6, 12 and 18 months after intervention.
Measured: up to 18 months after intervention
Change in youth unmet need for care
Unmet need for care will be assessed using a three-item scale from the National Survey of Children's Health items at 6, 12 and 18 months after intervention. Respondents report that they needed but did not receive care (yes/no).
Measured: up to 18 months after intervention
Change in youth psychiatric crisis care use
Psychiatric crisis care use will be measured by number of emergency department visits at 6, 12 and 18 months after intervention.
Measured: up to 18 months after intervention
Change in number of inpatient psychiatric stays
Inpatient psychiatric stays will be measured by number of stays at 6, 12 and 18 months after intervention.
Measured: up to 18 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Aug 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Participant
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Kathleen C Thomas, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986305
- Sponsor's protocol ID
- 23-0739
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT05986305
- Acronym / sponsor ID
- 23-0739
- Conditions
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 Aug 2023 (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.
This study will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities. Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.
Detailed description
A well-functioning system of care should provide a broad array of services that can support families with a child with complex health care needs. Nonetheless, adolescents and transition age youth with intellectual and developmental disabilities experience rates of unmet need for health care up to 6 times higher than others resulting in poor health and quality of life for themselves and their families.
The system of care approach has achieved positive impacts for children with intellectual and developmental disabilities and their families, but updates call for training to help parents develop advocacy skills on behalf of their children. Prior research on diverse populations indicates that parent advocacy skills are a promising target for increasing parent self-efficacy, which in turn is associated with better parent and youth health outcomes. Parent advocacy skills can be increased through a psycho-educational advocacy skills curriculum or through parent-directed peer-learning. However, the comparative effectiveness of these two strategies for families raising youth with intellectual and developmental disabilities is not yet known.
This study has two objectives. First, it will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities . Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Go Act | Active comparator | Behavioral: Go ActGo Act is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period. |
| Peer | Active comparator | Behavioral: PeerPeer is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period. |
Who may qualify
- Ages
- 11 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Parents
- Raising an adolescent or young adult child (age 11-27), with diagnosed or suspected intellectual or developmental disability
- Able to attend group sessions
- Able to give informed consent
- Resident of any state except New York or Illinois due to electronic signature law
Key exclusion criteria (2 listed)
- Parents
- Having evidence of emergency mental health needs
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 |
|---|---|---|
| Go ActGo Act sessions address becoming a parent who can 'Go Act,' caring for one's self as a parent, understanding and managing youth health needs, working with health providers as partners, and working with other service providers such as schools and vocational services. The intervention uses motivational interviewing, story-telling with self-disclosure, psycho-education introduced with a know-want to know-learned strategy, problem-solving, role play, and practice outside of class. | Behavioural | Go Act |
| PeerDuring Peer sessions facilitators lay ground rules for respectful and confidential sharing and encourage group discussion. The group provides a format to make personal connections through shared identity. Participants may discuss strategies for individualized advocacy, so that they learn from the experiences of others. | Behavioural | Peer |
Primary outcome
Change in parent activation
Time frame: up to18 months after intervention
The Parent Patient Activation Measure will be used to capture parent activation on behalf of their child (mean score=70) at 6, 12 and 18 months after intervention. The Parent Patient Activation Measure is a parent self-report 13-item scale with 4-level likert responses and scores ranging from 0 to 100.
Change in youth social functioning- life satisfaction
Time frame: up to18 months after intervention
Youth social functioning will be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children life satisfaction measure at 6, 12 and 18 months after intervention.
Change in parent depression
Time frame: up to 18 months after intervention
Parent depression will be measured with the 8-item Patient Health Questionnaire at 6, 12 and 18 months after intervention. The Patient Health Questionnaire is scored from 0 to 24.
10 secondary outcomes
Change in parenting self-efficacy
Time frame: up to 18 months after intervention
Change in shared decision-making
Time frame: up to 18 months after intervention
Change in alliance
Time frame: up to 18 months after intervention
Change in goal attainment
Time frame: up to 18 months after intervention
Change in stress
Time frame: up to 18 months after intervention
Change in observed parent activation
Time frame: up to18 months after intervention
Change in youth social functioning- meaning & purpose
Time frame: up to 18 months after intervention
Change in youth unmet need for care
Time frame: up to 18 months after intervention
Change in youth psychiatric crisis care use
Time frame: up to 18 months after intervention
Change in number of inpatient psychiatric stays
Time frame: up to 18 months after intervention
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 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board, Independent Ethics Committee, or Research Ethics Board, as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
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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.
Kathleen C Thomas, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go Act and Peer in people with Intellectual Disability, run by University of North Carolina, Chapel Hill at 2 sites 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 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 parent activation (time frame: up to18 months after intervention). The study lists 3 primary outcomes in all. 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 Oct 2026.