Improving the Health of Parents and Their Adolescent and Transition-age Youth With IDD

Study Overview
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Brief Summary
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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 (IDD) 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 IDD 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 psychoeducational advocacy skills curriculum or through parent-directed peer-learning. However, the comparative effectiveness of these two strategies for families raising youth with IDD is not yet known. This study has two objectives. Fist, it will determine the comparative effectiveness of GOACT, a tailored advocacy curriculum versus PEER parent-directed peer learning for increasing parent activation for parents of youth with IDD. 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.

Official Title
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Improving the Health of Parents and Their Adolescent and Transition-age Youth With IDD

Conditions
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IDD

Intervention / Treatment
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* Behavioral: GOACT
* Behavioral: PEER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents Bringing their adolescent or young adult child (age 11-27), with diagnosed or suspected intellectual or developmental disability, to one of the participating clinics Able to attend group sessions Able to give informed consent Resident of North Carolina Youth Being between the ages of 11 and 27 Having diagnosed or suspected intellectual or developmental disability Being present for a visit at one of the study clinics Exclusion Criteria: Parents Having evidence of emergency mental health needs Not willing to be recorded

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GOACT<br>GOACT is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period. | Behavioral: GOACT<br>* GOACT 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.<br>|
| Active Comparator: PEER<br>PEER is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period. | Behavioral: PEER<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in parent activation | The Parent Patient Activation Measure (PPAM) will be used to capture parent activation on behalf of their child (mean score=70) at 6, 12 and 18 months after intervention. The PPAM is a parent self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100. | up to18 months after intervention | 
| Difference in change in youth social functioning- life satisfaction | Youth social functioning will be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children (Pediatric PROMIS) life satisfaction measure at 6, 12 and 18 months after intervention. | up to18 months after intervention | 
| Difference in change in parent depression | Parent depression will be measured with the 8-item Patient Health Questionnaire (PHQ-8) at 6, 12 and 18 months after intervention. The PHQ-8 is scored from 0 to 24. | up to 18 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in parenting self-efficacy | The Tool to Measure Parenting Self-Efficacy (TOPSE) will be used to assess parent self-efficacy at 6, 12 and 18 months after intervention. The TOPSE 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. | up to 18 months after intervention | 
| Difference in change in shared decision-making | Shared decision-making (SDM) will be assessed using a three-item scale from the National Survey of Children's Health (NSCH) 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. | up to 18 months after intervention | 
| Difference in change in alliance | The adapted Parenting Alliance Inventory (PAI) will be used to measure parent-teacher alliance at 6, 12 and 18 months after intervention. The PAI 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. | up to 18 months after intervention | 
| Difference in change in goal attainment | Goal attainment will be assessed with the Psychometric equivalence tested goal attainment scale (GAS) at 6, 12 and 18 months after intervention. The GAS measurement system is based on a 5-point response scale ranging from -2 (worse expected outcome) to 2 (best expected outcome). | up to 18 months after intervention | 
| Difference in change in stress | Parent stress will be measured with the 17-item Parental Stress Scale (PSS) at 6, 12 and 18 months after intervention. Mean scores range from 1 to 5 with higher scores indicating higher stress. | up to 18 months after intervention | 
| Difference in 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. | up to18 months after intervention | 
| Difference in 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 (Pediatric PROMIS) meaning and purpose measure at 6, 12 and 18 months after intervention. | up to 18 months after intervention | 
| Difference in 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 1) that they needed but did not receive care (yes/no), 2) types of care not received, and 3) reasons for not receiving care. Counts of reasons (0 to 6) are summed for each of 5 types of care. | up to 18 months after intervention | 
| Difference in 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. | up to 18 months after intervention | 
| Difference in 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. | up to 18 months after intervention |